TWI232104B - Compositions for the treatment of viral infections - Google Patents

Abstract

This invention relates to compositions derived from Chinese herbal medicines, medicinal plants and extracts thereof, and to their use for the treatment of animals infected with viruses, especially with hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV). More specifically, the compositions of the present invention are derived from various Chinese herbal medicines or medicinal plants which have a long history of human consumption. The compositions of the invention are obtained through specific techniques and have demonstrated outstanding efficacy for treating human HBV carriers and hepatitis C patients. Compositions according to the invention have also exhibited in vitro antiviral activities against murine leukemia virus (MuLV) and HIV. HIV is the virus known to cause acquired immunodeficiency syndrome (AIDS) in humans and AIDS presents special problems to the medical community which the present invention addresses.

Description

1232104 A7 B7 Fifth invention description (printed by the Consumers' Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs j_L_Application This application filed an application number 6〇 / 〇161〇〇 on July 9, 6th, and its name is Provisional application for a viral agent; and application priority for an antiviral agent from Chinese herbal medicine number 60 / 021,467, filed on July 10, 1996. Technical Scope The present invention relates to Compositions of substances of antiviral active components of medicinal plants and their extracts, and their treatment of viruses, especially hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV) Use of infected humans or animals. More specifically, the composition of the substance of the present invention is derived from various Chinese herbal medicines or medicinal plants with a long history of human consumption. The composition of the substance of the present invention is obtained through special techniques, and Has proven efficacy in the treatment of human HBV carriers and patients with hepatitis C. The composition of the substance according to the invention also shows resistance to murine leukemia virus (MuLV) and HIV in vitro Activity. HIV is a virus known to cause acquired immunodeficiency syndrome (AIDS) in humans, and AIDS poses special problems to the medical community, which is the focus of the present invention. Individual antiviral active herbs or medicinal plants or extracts thereof The active ingredients have been separated by this special separation technique and have been characterized by the use of recognized chemical techniques. BACKGROUND Modern medical science is constantly looking for new and more effective agents to prevent, treat or hinder histobacter and viral infections, and Treatment of those caused by diseases. Bacterial and viral infections of humans and domestic animals cost hundreds of millions of dollars each year. Chinese national standards (CNS) A4 specifications (2Η) X 297 mm are applied to this paper standard. Please read the note on the back. Matters are again fm! R · Ben 1). Binding · Binding · HI n 1232104 A7 B7 Printed by the Consumer Cooperatives of the Central Bureau of Standards of the Ministry of Economic Affairs 5. Description of the invention (2) Pharmaceutical companies spend huge sums of money on identifying, characterizing and manufacturing new antibiotics and Antiviral agents have emerged as a serious problem against emerging drug-resistant strains. Reliable preventive management of disease prevention is also a major concern. But despite the cost and effort of identifying treatments for viral infections such as hepatitis and aids, effective treatments remain elusive. Hepatitis is a disease of the human liver. It is expressed as inflammation of the liver and is usually caused by a viral infection, and is sometimes derived from toxic agents. Hepatitis can progress to cirrhosis, liver cancer, and eventually death. Several viruses such as hepatitis A, B, C, D, E and G are known to cause various types of viral hepatitis. Among them, HBV and HCV are the most serious. HBV is a DNA virus with a virus particle size of 42 nm. HCV is an RNA virus with a virion size of 30-60 nm. See D. S. Chen, J. Formos. Med. Assoc., 95 (1), 6-12 (1996). Hepatitis B is a major health problem worldwide, especially in Asia and Africa. About 300 million people are chronically infected with HBV worldwide. More than one million HBV carriers were found in the United States. HBV infection is currently the main cause of cirrhosis and cancer. HBV carriers are not only the long-term preservation of the virus, but also can develop chronic liver disease and have a greatly increased risk of cirrhosis and cancer. Progression from chronic hepatitis B to cirrhosis often occurs without noticeable deterioration and without significant changes in symptoms. Once symptoms of sclerosis or cancer appear, treatment is almost priceless. HBV infection can be prevented through safe and effective vaccination. However, vaccination is not effective in treating those who are already infected, ie, carriers and patients. Many drugs have been used to treat chronic hepatitis B, and none have proven effective except interferon. The treatment with interferon has limited success, and this paper size is applicable to the Chinese National Standard (CNS) A4 specification (210X297 mm) (Please read the precautions on the back page first)

1232104 A7 B7 Printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs 5. Description of the Invention (3) Frequent and adverse side effects such as fatigue, fever, chills, headache, muscle weakness, mild baldness, psychiatric effects and related diseases Autoimmune phenomena and related disorders and thyroid insufficiency. Treatment with interferon has been effective for 16 weeks, with continuous loss of viral replication in approximately 40% of patients with hepatitis B. Most of the responders showed normal serum levels of aminotransferases and low recurrence rates. See R.P. Perrillo, Digestive Diseases and Sciences, 38 (4) · 577-593 (1993). However, Chinese patients receiving interferon therapy for chronic hepatitis B have reported a higher long-term recurrence rate (24%). See ASF Lok, T. Chung, VWS Liu, & 0CK Ma, Gastroenterology, 105 (6), 1833-1838 (1993). Also, in patients treated with interferon, 10-15% serum Hepatitis B surface antigen (HB s Ag) disappeared. The loss of HB s Ag is consistent with the disappearance of HB V. In HBsAg-negative patients, subsequent improvements in liver histology continued for several years. The lack of disease progresses, so it is believed that when treatment is provided in the pre-sclerotic stage of infection, it leads to prevention of liver cancer. See R. P. Perrillo, Digestive Diseases and Sciences, 38 (4) · 577-593 (1993). Hepatitis C has previously been described as non-A and non-B hepatitis, which is caused by HCV. There are about 100 million HCV carriers in the world. An estimated 3.5 million people in the United States have chronic hepatitis C. HCV infection can lead to cirrhosis and cancer with fewer clinical manifestations. Most people with hepatitis C do not have a specific syndrome and are therefore easily overlooked until treatment is too late. This raises a more serious problem than hepatitis B. HCV carriers also become long-term storage pathogens of the virus and eventually develop chronic liver disease, which greatly increases the risk of cirrhosis and cancer. See D. S. Chen, Science, 262, 369-370 (1993). -6- This paper size applies to the Chinese National Standard (CNS) A4 specification (210X297 mm). Please read the precautions on the back before loading this page).

1T 1232104 A7 B7 Printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs 5. Description of the Invention (4) There is currently no effective immunization available, and hepatitis C can only be prevented by preventive measures such as improvements in hygiene and health conditions and fight against Break route. Currently, the only acceptable treatment for chronic hepatitis C is interferon, which requires at least 6 months of treatment. The initial treatment had a response rate of about 50%. However, after stopping interferon treatment, half of them relapsed. As a result, only about 25% of patients have a sustained response. See DS Chen, J. Formos. Med. Assoc., 2iXl), 6-12 (1996) and N. Terrault & T. Wright, New Engl. J. Med., M (22), 1509-1511 (1995 ). Because interferon therapy has limited effectiveness and often has adverse effects, more effective therapies are needed. AIDS is a fatal disease caused by HIV. Since the disease was first described in 1981 and its cause was discovered in 1983, HIV has been a worldwide problem. In 1993, about 13 million people became infected with the world-famous HIV infection. In 1996, the number has increased to about 21 million. See B. Jasny, Science, 2M (5112), 1219 (1993) and P. Piot, Science, 271 (5270), 1855 (1996). Several drugs have been shown to treat this devastating disease, such as azidovudine (AZT), didanosine (dideoxymidine, ddl), d4T, zalcitabine (two Deoxycyte, ddC), nevirapine, lamivudine (epivir (3TC)), saquinavir (invirase) Ritonavir (Norvir), indinavir (Crixivan) and delavirdine (Rescriptor). See M.I. Johnston & D.F. Hoth, Science, 260 (5112), 1286-1293 (1993) and D, D. Richman, (please read the precautions on the back-installation-this page) The paper size of the book is applicable to the Chinese National Standard (CNS) A4 specification (210X297 mm) 1232104 A7 B7 V. Description of the invention (5)

Science, 272 (5270) · 1886-1888 (1996). All drugs currently proven for the treatment of AIDS inhibit the proliferation of the virus and are viral reverse transcriptase inhibitors or viral protease inhibitors. More protease inhibitors. Such as nelfinavir and improved saquinavir are under development. The AIDS vaccine (Salk ' s vaccine) has been tested and several proteins found as chemokines from CD8 have been identified as HIV inhibitors. In addition to the synthetic nucleolus analogs, proteins, and antibodies described above, several plants and plant-derived substances have been found to have anti-HIV activity in vitro, such as Lonicera japonica and Prunella vulgaris. And glycyrrhizin from Glycyrrhiza radix, see R.S. Chang & W. Yeung, Antiviral Research, 2_, 163-175 (1988) and M. Ito et al., Antiviral Research, L 127- 137 (1987). Although all available medicines are available to treat HIV, there is no cure for this deadly disease. The HIV virus continues to mutate and becomes resistant to existing drugs such as reverse transcriptase and protease inhibitors. Recently, treatment with a mixture of 2 or 3 anti-HI V drugs has been found to be effective in significantly reducing the load of H V in AIDS patients. The results are promising. However, patients continue to develop resistance to the drug, and long-term outcomes (survival and cure ratio) remain unknown. As a result, the world's medical community continues to look for medicines that can prevent HIV infection, treat HIV carriers, and prevent them from progressing to the deadly AIDS, as well as treating AIDS patients. Herbs Herbs and folk medicine have been used in China for thousands of years. These herbs started-8-Zhang scales apply Chinese National Standards (CNS) Cong Mi (21〇 > < 297 cm) (Please read the precautions on the back first. II Pack — Order this page from the Central Bureau of Standards of the Ministry of Economic Affairs Printed by employee consumption cooperation 1232104 A7 B7 V. Description of invention (6) In the treatment of countless diseases, from arthritis to viral infection, western medicine has previously been regarded as ineffective and dangerous. In the 19th century, many home medical medicines containing herbs Patented and sold. Modern medicine has replaced those of home medicine, but many modern medicines contain ingredients derived from herbs. For example, in 1776, British botanist and doctor William Withering learned an herb made by an old peasant woman, It is effective in treating edema or excess water in tissues, which is caused by the heart not strong enough to punch out blood. It found that a component of the medicine is made from the leaves of the inflorescence plant, which strengthens the heart's ability to beat. The medicine made from the top flower plant is now called foxglove. Folk medicine is a fairly modern term for the West, but it means the care and treatment of diseases through various herbs. In recent years, people Medicine has become a growing concern in the Western scientific and medical communities. Previously, the technique-printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Herbal Economics, called AEGINETIAE HERB A. , Urinary tract infection, osteomyelitis, palate, psoriasis, goiter, pharyngitis, thyroiditis, enteritis, liver disease, cancer, rheumatism, vomiting, neurasthenia, redness, itching, irregular menstruation, edema, jaundice, hernia , Snake bites, and pediatric developmental disorders. The official line is made from whole plants belonging to the Aeginetia indica. The therapeutic dose of dried plants is typically from 4 to 150 grams per day. It should be noted that Plants are bitter and toxic.

Okubo et al. Revealed that phosphate-buffered saline (PBS) extract (pH 7.2, at ambient temperature to 4 ° C) obtained from the seeds of wild coriander showed excellent carcinogenesis and interleukin-2 and interferon flammability. Effect. PBS is 0.1M phosphate buffer -9- This paper size is applicable to Chinese National Standard (CNS) A4 specification (21 ×: 297 mm) 1232104 A7 B7 printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs 7) physiological saline, pH 7.2, without Ca or Mg ions. The extracted substance is shown as a macromolecular polysaccharide, which may or may not contain lipid A bound to the protein, depending on whether it is extracted with butanol or phenol. The extracted material is soluble in water but not in n-butanol. Its molecular weight is in the range of 100,000 to 200,000 ears. See S. Okubo, M. Sato, & K. Himeno, U.S. Patent No. 5,366,725, published on November 22, 1994. Chinese herbal medicine called Banphiccanthis Rhizoma ET Radix is traditionally used to treat many diseases such as fever, abscess, erysipelas, swollen throat, headache, yellow acne, skin disease, vaginal discharge and syphilis. Isatis roots are prepared from dried rhizomes and the roots of Baphicacanthes cusia, Strobilanthes cusia, Isatis tinctoria, Isatis indigotica or Polygonum tinctorium. This herb has been reported to inhibit cold viruses in vitro. The decoction of Daqing Root boiled in water has also shown an antibacterial effect. Daqingye and Malan belong to the family Juebeidae. Daqing and Isatis indigotica belong to the family Brassicaceae. Lvdai belongs to the family Pupae. The therapeutic dose is typically 10 to 19 grams per day for BAPHICACANTHIS RHIZOMA ET RADIX.

Ho et al. Disclosed the use of extracts obtained from a mixture of herbs including Daqing for the living body to suppress HIV infection in human T lymphocytes and mononuclear phagocyte lineage cells. The activity is based on test results obtained from a water extract of a mixture of 3 herbs: Isatis indigotica, Lonicera japonica, Polygonum bistorta. See D. D. Ho & X. S. Li, U.S. Patent No. 5,178,865, published on January 12, 1993. -10-This paper size applies Chinese National Standard (CNS) A4 (21 × 297 mm) ~ '(Please read the note on the back page first) Preparation 1232104 A7 B7 V. Description of the invention (8) The compound called tryptanthrin is used as the main anti-bacteria agent in the leaves of horse blue, and the main anti-skin plant is used in the green leaves and green leaves Material clocks don't come out. See Η · Y · Hsu, Y. P_ Chen, & M. Hong, Chemical Composition of Oriental Herbs, Volume 2, Oriental Healing Arts Institute, Los Angeles, Califomia, USA, 758-759 (1985) ° is called Guan BLECHNI RHIZOMA Chinese herbal medicine, also known as Mianmagen, is traditionally used to treat diseases such as cuts, edema, fever, mochi and erysipelas. The Guanzhong line is prepared from the dried roots and stems of blechnum orientale belonging to the water dragon orthopaedics or the black hair fern family. Mianma root system is prepared from the dried roots and stems of Mianma belonging to the trigeminaceae family. Osmundajaponica (Asteraceae), Woodwardia orientalis and Woodwardia unigemmata (Aconopteraceae), Athyrium acrostichoides (Faceae), Sphaeropteris lepifera (Asteraceae), Cyrtomium falcatum, Cyrtomium fortunei (Trigeminaceae) have also been used to prepare these herbs. These herbs are bitter and astringent and are slightly toxic. The therapeutic dose is typically 4 to 11 grams per day. Blechnum fern has also shown a strong inhibitory effect on influenza viruses. Filmarone, Mianma acid, Mianmasu, White Mianmasu, and Mianmaic acid found in Mianma have been characterized as insect repellent. See Η. Y. Hsu, YP Chen, SG Hsu, JS Hsu, CJ Chen, & HC Chang, Concise Pharmacognosy, New Medicine Publishing Company, Taipei, ROC ·, 577-578 (1985); and Η · Υ · Hsu Υ · Ρ · Chen, & Μ · Hong, Chemical Composition of Oriental Herbal Medicine, Oriental Healing Arts Institute, Los -11-This paper size applies to Chinese National Standards (CNS) (21 OX297 mm) (Please read the back Note on this page), τ 1232104 A7 B7 V. Description of the invention (9)

Angeles, California, U.S.A., 249-250 (1982)

Hozumi et al. Revealed that Mianma root is used as an anti-cancer therapeutic virus agent, an anti-poliovirus agent, and an anti-varicella-zoster virus agent. The roots of Guanzhong and the rhizomes of the Eastern Dog Spine are also revealed as anti-arsenic virus, anti-poliomyelitis virus, anti-measles virus, anti-varicella-zoster virus and anti-mast cell virus (CMV) agent, and as anti-DNA and Anti-RNA virus agent. See T. Hozumi, T. Matsumoto, H. Ooyama, T. Namba, K. Shiraki, M. Hattori, M. Kurokawa, & S. Kadota, U.S. Patent No. 5,411,733, published on May 2, 1995 . Chinese herbal medicine called BLITILLAE TUBER has traditionally been used to treat diseases such as coughing blood, potential blood, vomiting blood, abscesses, burns, dry and cracked skin, tuberculosis, gastric ulcer, and sores. Antibacterial and antibacterial properties. The white sturgeon is prepared from dried tubers of the white sturgeon (Bletilla / striata) belonging to the orchid family. Paeonia lactiflora is bitter, sweet, astringent and non-toxic. The therapeutic 'dosage' is typically 2 to 11 grams per person. Chinese herbal medicine called CIRSII RHIZOMA ET RADIX, printed by the Consumer Cooperative of the Central Bureau of Standards of the Ministry of Economics, is traditionally used to treat diseases such as vomiting blood, acute infectious hepatitis, bleeding from cuts, sores and abscesses. Thistle is prepared from dried rhizomes or roots or whole plants of plants belonging to the family Asteraceae, such as Cirsium japonicum, Cirsium albescens, and Cirsium japonicum var. Australe. Small thistle is made from dried roots of plants of the family Asteraceae, such as Brea segetum, also known as Cephalanoplos segetum and Breea setosum. Both herbs have a sweet and slightly bitter taste and are non-toxic. The therapeutic dose for an average human is typically 5 to 75 grams per day. -12- This paper size applies to Chinese National Standard (CNS) A4 (210X297 mm) 1232104 A7 B7 Printed by the Consumers' Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs 5. Description of the invention (10) Called horseshoe gold Chinese herbal medicines are traditionally used to treat diseases such as yellow cancer, dysentery, gonorrhea, edema, abscesses, convulsions, encephalitis, rheumatism, hernia, diabetes and hypertension. Horseshoe gold is prepared from whole plants of Dichondra repens or Dichondra micrantha (which belongs to Convolvulaceae). This plant is bitter and non-toxic. The therapeutic dose of dried plants is typically 10 to 40 grams per day. Nine compounds isolated from n-hexane and ethanol extracts of horseshoe gold's whole grass have been identified. These compounds are maltitol, umbelliferone, 7-hydroxy-6-methoxycoumarin, umbelliferone-7-0-carbofuran glucose, buttercup spirit, asragalin , Black Oak Peel Answer, Kempferol-3-Ruxiang Fen, and Pipi Taste-3-0-Rudol '^. See C.-J. Chou, L.-C. Lin, S.-Y. Hsu ^ LC.-F. Chen, J. Chin. Med., 4 (2), 143-149 (1993). Chinese herbal medicine called FORS YTHIAE FRUCTUS is traditionally used to treat diseases such as sores, abscesses, lymph node swelling, urethritis and hypertension. It has also been found to inhibit several bacteria and influenza viruses. Lianmei line is prepared from dried mature fruits of Forsythia suspensa, Forsythia viridissima or Forsythia koreana (belonging to the family Oleaceae). This herb is bitter and non-toxic. The therapeutic dose is typically 3 to 11 grams per day. Hozumi et al. Revealed that the fruit of Forsythia suspense is an anti-poliovirus agent and an anti-narcotic virus agent for treating these viral infections. See T. Hozumi, T. Matsumoto, H. Ooyama, T. Namba, K. Shiraki, M. Hattori, M. Kurokawa, & S. Kadota, U.S. Patent No. 5,411,733, published on May 2, 1995 . -13- Ben, "Zhang's scale is applicable to the Chinese National System ^ ((: milk) 8 4 specifications (210/297 public envy ^ ~ (Please read the precautions on the back before this tile)-Order-Order 1232104 A7 B7 Description of the Invention (H) Compounds Forsythia A (found in the leaves of Forsythia), Forsythiaside B (found in the stems of Korean Forsythia), and Forsythia C and Forsythia D (found in the fruits of Forsythia) have been reported Shows antibacterial activity against Staphylococcus aureus at a concentration of less than 2 mM. Suspensaside (found in Fructus Forsythia, like Forsythia suspensa C) has also been reported to show a minimum inhibitory concentration (MIC) of 2.6 mg / ml on gold Antibacterial activity of Staphylococcus aureus Terashima. See HY Hsu, TP Chen & M. Hong, Chemical Composition of Oriental Herbs, Volume 2, Oriental Healing Arts Institute, Los Angeles, California, USA, 53-55 , 142-143 (1985). Chinese herbal medicine called Bozhijiacao (also known as OLDENLANDIAE HERBA) is traditionally used to treat diseases such as urinary tract infections, pharyngitis, laryngitis, tonsillitis, subacute or chronic , Coccygeal pain, appendicitis Bowel cancer, bruises, and eye diseases. It has also been found to have weak antibacterial activity in vitro. Bochia grass is prepared from dried whole grass of Hedyotis diffusa (also known as Oldenlandia diffusa (part of Rubiaceae)). This herb is sweet and non-toxic. The therapeutic dose is typically 19 to 300 grams per day. It is printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs (please read the precautions on the back before this page) and it is called Hu Zhizi Chinese herbal medicine (LESPEDEZAE HERB A) and arrowhead (SENECINIS HERBA) are traditionally used to treat diseases such as urinary incontinence, gonorrhea, asthma, stomach pain, general weakness and failure, diarrhea, contusion, eye disease, red eyes, kidney disease, acute inflammation Sexual diseases, cataracts, dysentery, enteritis, jaundice, colds, septicemia, sores, edema and palm disease. Lespedezae HERBA is a dry whole grass from Lespedeza cimeata (belonging to legumes). Prepared. Senecinis Herba A is dried from Senecio scandens (belonging to Asteraceae) -14- This paper size is applicable to Chinese National Standard (CNS) A4 (210X297 mm) 12 32104 A7 B7 Printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs 5. Description of the invention (12) Preparation of whole grass. Night-closing doors and Senecio have been shown to have antibacterial effects. Both herbs have a sour, astringent and bitter taste. The therapeutic dose is typically 4 to 40 grams per day. Traditional Chinese herbal medicine called Ligustrum Fructus is traditionally used as a conditioner and to treat diseases such as insomnia, constipation, early white hair, cervical lymph node tuberculosis and edema. Ligustrum lucidum is prepared from dry mature fruits of Ligustrum lucidum or Ligustrum japonicum (which belongs to the family Osmanthaceae). Ligustrum lucidum leaves have been used as antipyretics, analgesics and anti-inflammatory agents. The leaves of Ligustrum lucidum have also been used to treat diseases such as eye pain, ulcerative gastritis, mastitis, edema and burns. The fruit of Ligustrum lucidum is bitter and non-toxic. The therapeutic dose of dried fruits is typically 6 to 20 grams per day. Dry leaves are typically 40 to 75 grams per day. Chinese herbal medicine called LONICERAE FLOS is traditionally used to treat diseases such as fever, acute infectious diseases, anaesthesia, dysentery, enteritis, addiction, and similar skin diseases. Honeysuckle is prepared from dried flower buds of Lonicera japonica or Lonicera confusa. Two plants belong to the honeysuckle family. Honeysuckle flowers have diuretic, antipyretic, anti-inflammatory, anticonvulsant, antibacterial and antiviral properties. Flower buds are also used as diuretics. This herb is sweet and non-toxic. The therapeutic dose is typically 1 to 75 grams per day for a typical human. Ho et al. Revealed the in vitro anti-HI V activity of honeysuckle, Daqing (or blue) and a mixture of Polygonum bistorta or honeysuckle and Huangda. An aqueous extract of this mixture, treated with ethanol precipitation and carbon adsorption, is disclosed for the preparation of an anti-HIV active composition, see D. D. Ho & X. S. Li, U.S. Patent No. 5,178,865 published on January 12, 1993. Several tannins such as coffee quinolinate isolated from honeysuckle have been reported to be anti-15 against HIV-1. This paper size applies Chinese National Standard (CNS) A4 specification (2.0 × 297 mm) (please read the back first) Precautions for this education).

1T 1232104 A7 B7 V. Description of the invention (13) Transcriptase activity has inhibitory effect, see C.-W. Cheng, M.-T. Lin, S.-S. Lee, KCSC Liu, F.-L. Hsu & J.-Y. Lin, Antiviral Research, 22, 367-374 (1995). A mixture of water extracts of honeysuckle flower buds and forsythia fruits and crude flavonoids from Scutellaria baicalensis has shown antibacterial and antiviral properties. . A group of patients with severe respiratory disease were treated with this mixture, and they responded as a control group treated with standard antibiotics. See P. J. Houghton, Z. Boxu, & Z. Xisheng, Phytother. Res., Z, 384-386 (1993). Called PHELLODENDRI CORTEX, it has been traditionally used to treat diarrhea, diarrhea, jaundice, blood in the stool, abdominal pain, indigestion, bacterial enteritis, and tuberculosis-like diarrhea. Herbal medicine has also been used to prepare eyewash, to strengthen the stomach and intestines to stimulate appetite, and as an astringent, anti-inflammatory agent and the like. It has antibacterial, anti-inflammatory and wound healing properties. Scutellaria baicalensis is derived from the dried cortex of plants of the family Rutaceae, such as Phellodendron amurense, Phellodendron chinense, Phellodendron amurense var. Sachalinense, and Phellodendron wilsonii. Scutellaria baicalensis is bitter and non-toxic. The therapeutic dose is typically 1 to 11 grams per day. Employees' Cooperatives of the Central Bureau of Standards of the Ministry of Economic Affairs

Hozumi et al. Revealed that the bark of Scutellaria baicalensis was used as an antiviral virus, an anti-poliomyelitis virus, an anesthetic virus, an anti-strip cancer virus, an anti-CMV agent, and an anti-DNA virus and anti-RNA virus agent. See T. Hozumi, T. Matsumoto, H. Ooyama, T. Namba, K. Shiraki, M. Hattori, M. Kurokawa, & S. Kadota, U.S. Patent No. 5,411,733 'May 2, 1995 Publication . -16-This paper size is in accordance with Chinese National Standard (CNS) A4 (21 0X 297 mm) 1232104 A7 B7 V. Description of the invention (14) Called Polygonum cuspidatum (POL YGONI CUSPID ATI RHIZOMA) Chinese herbal medicine, traditionally used Come to treat diseases such as red dysentery, menstruation, dysmenorrhea, difficulty urinating, retarded growth of the baby and appendicitis. Polygonum cuspidatum is prepared from Polygonum cuspidatum, Polygonum runcinatum, or Polygonum reynoutria (also known as Reynoutria japonica), which belongs to the rare family. Its young leaves are also used to treat contusions and cuts. Herbal extracts have shown antibacterial and antiviral effects in vitro. Excessive use of herbs can cause mild diarrhea. The herbs have a bitter taste and a therapeutic dose of typically 6 to 40 grams per day.

Hozumi et al. Revealed the roots and rhizomes of Polygonum cuspidatum as anti-herpes virus, anti-poliomyelitis virus, anti-shingles virus, and anti-CMV agent. See T. Hozumi, T. Matsumoto, H. Ooyama, T. Namba, K. Shiraki, M. Hattori, M. Kurokawa, & S. Kadota, U.S. Patent No. 5,411,733, published on May 2, 1995 . Resveratrol has been reported as an antifungal and antibacterial component in the roots of Polygonum cuspidatum. See ΗY. Hsu, ΥP. Chen, & M. Hong, Chemical Composition of Eastern Herbs, Book 2, Oriental Healing Arts Institute, Los Angeles, California, U.S.A., 51 (1985). The Consumer Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs printed a Chinese herbal medicine called PRUNELLAE SPICA, which is traditionally used to treat diseases such as goiter, hemorrhoids, enlarged eyes, eye pain, gonorrhea, uterine disease, mastitis, breast Abscesses, breast cancer, chronic arthritis, conjunctivitis and hypertension. Prunella vulgaris is prepared from dried flower spikes or whole grass of Yuzhou Prunella vulgaris or Prunella vulgaris subsp. Asiatica (also known as Prunella vulgaris vra. Lilachina). Both plants belong to the lip -17- This paper size applies to the Chinese National Standard (CNS) A4 ^ Luo (210X297 mm) 1232104 A7 B7 Printed by the Consumer Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs 5. Description of the invention (15) Forms. Whole plants can be used as diuretics and also have antibacterial effects in vitro. This herb is bitter and non-toxic. The therapeutic dose is typically 4 to 110 grams per person for an average human. Hozumi et al. Revealed that Yuzhou prunella vulgaris was used as an anti-herpes virus agent to treat herpes virus infection. See 1 \ 11〇211111 丨, 1 \ 1 ^ 15111110 plus, 11 · Ooyama, T. Namba, K. Shiraki, M. Hattori, M. Kurokawa, & S. Kadota, US Patent No. 5,411,733, 1995 Announced on May 2, Water extract of Luzhou prunella vulgaris (3 grams boiled in 100 ml of water for 45 minutes). Anti-HIV (H9 / 3B strain) activity has also been reported. The extract also shows synergistic anti-HIV activity with aziridine (AZT) and danoxin (ddl). Only a slight addition was observed for Prunella vulgaris and Citabine (ddC). See JF John, R. Kuk? &Amp; A. Rosenthal, Abstr. Gen. Meet. Am. Soc. Microbiol., 94, 481 (1994) 0 In vitro assessment by Yamasaki et al. It is a kind of crude drug, and it is reported that the hot water extract of Luzhou prunella vulgaris (flower spike) shows strong anti-HIV-1 activity in vitro and has IQ. . 16 μg / ml. See 1 (:-Yamasaki, T. Otake, H. Mori, M. Morimoto, N. Ueba, Y. Kurokawa, K. Shiota, & T. Yuge, Yakugaku Zasshi, 113 (11), 818-824 (1993 Yao et al. Reported that the dried whole plant water extract of Luzhou Prunella vulgaris inhibits HIV-1 replication in vitro and is active, and has relatively low cytotoxicity to MT-4 cells. This extract is also effective in reverse transcriptase inhibition. It is active. The active factor is purified and identified as an anion with a molecular weight of about 10,000 channels. This active component can be like prunellin, such as by Tabba et al. Below-(Please read the precautions on the back first This page). The size of the paper is in accordance with the Chinese National Standard (CNS) A4 (210X297 mm) 1232104 A7 B7. 5. Description of the invention (16). The purified extract is 6, 30 and 12.5 μg / ml. Effective concentrations inhibit HIV-1 replication in lymphoid cell line MT-4, monocyte-like cell line U937, and peripheral vascular mononuclear cells (PBMC). Prior to virus exposure, this extract was pretreated without infection Cells do not prevent HIV-1 infection. HIV-1 and purified extract Pre-cultivation of the material drastically reduces infectivity. The purified extract can also block the transmission of HIV-1 cells to cells, prevent the formation of fused cells, and interfere with the ability of HIV-1 and purified gpl20 to bind to CD4. PCR ( Polymerase chain reaction (PCR) analysis confirmed the absence of HIV-1 provirus in cells exposed to the virus in the presence of the extract. The results suggest that the purified extract antagonizes HIV in susceptible cells by preventing the virus from attaching to the CD4 receptor -1 infection. See 乂. And Ya 30, ^ 1. 1 Wainberg, & MA Parniak, Virology, 187 (1), 56-62 (1992).

Tabba et al. Isolated and partially characterised the anti-HIV component, prunella vulgaris, from the water extract of the dried inflorescence of Prunella vulgaris. Prunella is a carbohydrate with an in vitro anti-HIV-1 MIC (minimum inhibitory concentration) of 2.2 μg / mL. It was identified as a partially sulfated polysaccharide with a molecular weight of about 10,000 channels. See H. D. Tabba, R. S. Chang, & K. M. Smith, Antiviral Research, U, 263-273 (1989)

Zheng evaluated 472 traditional herbs for antiviral action against herpes simplex virus type 1 (HSV1). Luzhou prunella is one of 10 highly effective herbs found in vitro. Clinically, 78 cases of herpes keratitis due to HSV1 were treated with Yuzhou Prunella vulgaris and Pyrrosia lingua eye drops. Among them, 38 cases were effectively cured, 37 cases showed improvement, and 3 cases showed no benefit. See M. Zheng, J. -19- This paper size applies to Chinese National Standard (CNS) A4 (210X297 mm) 1232104 A7 B7 Printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs 5. Description of the invention (17

Tradit. Chin. Med., And (3), 203-206 (1988). Triterpene 1 and triterpene 2 isolated from Prunella vulgaris showed antiviral activity against HSV1. Triterpene 1 was identified as betulinic acid and triterpene 2 was identified as 2α, 3 ubiquitin-dilight-based Wusan-12- 晞 -28-acid. The EC50 was estimated to be 30 μg / ml for three boxes of 1 and 8 μg / ml for triterpene 2, which was determined by plaque reduction. See S. Υ. Ryu, CK. Lee, C. Lee, Η S. Kim, & O. Zee, Arch. Pharmacal Res. (Seoul), 11 (3), 242-245 (1992 ) 〇 Called SCUTELLARIAE BARBATAE HERBA is traditionally used to treat diseases such as hematemesis, gonorrhea (with trace blood), sores, cancer, convulsions, pneumonia, enteritis, coccygeal pain, appendicitis, asthma, cancer, And rheumatism. It has also been found to have antibacterial effects. Scutellaria is prepared from Scutellaria barbata, Scutellaria rivularis, or Scutellaria dependens, and belongs to the Labiatae family. This herb is bitter and should not be taken by people with anemia. Pregnant women should avoid taking this herb. The therapeutic dose is typically 4 to 300 grams per day. The dried whole plant of Scutellaria rivularis is used in folk medicine to treat tumors, hepatitis, cirrhosis and other diseases in China and Taiwan. See Y. L. Lin, H. Kuo, G. H. Lee, and S. Ivi peng chem Research (S), 320-321 (1987). Sprouts isolated from whole grass of Scutellaria rivularis have anti-influenza virus activity. See Τ · Nagai et al., Pharm Bull., 38. (5), 1329-1332 (1990) 0 Chinese herbal medicine called SOLANI HERBA, traditionally used for curing diseases-20-This paper size applies Chinese national standards (CNS) A4 specification (210X297 male water chestnut-

Printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs 1232104 A7 B7 V. Description of the invention (18) Rugao, acute nephritis, cancer and epidemic diseases. Solanum nigrum is prepared from dried whole plants of Solanum nigrum (belonging to the family Solanaceae). Long steamed extracts have proven anti-inflammatory properties. Its fruits also show a cough suppressant effect and relieve bronchial inflammation. This herb has a bitter and slightly sweet taste and is non-toxic. The therapeutic dose is typically 11 to 60 grams per day. The compound solanine (found in the whole grass, fruits, leaves and fresh immature berries of Solanum nigrum) has anti-inflammatory effects similar to cortisone. Solanine and solanine (also found in solanum) have the ability to increase or decrease blood glucose levels in rats (depending on the animal's condition). Solanine has also been reported to have a stimulating effect on the heart, while solanine has an inhibitory effect. When administered in small doses, solanine promotes the stimulation of the central nervous system in animals (ie rats and rabbits). On the other hand, when administered in large doses, it promotes the inhibitory process. Su Jie test can also reduce blood clotting. See (1) Y · Y · Hsu, Υ · P. Chen, SG · Hsu, JS Hsu, CJ Chen, & HC Chang, Concise Pharmacognosy, New Medicine Publishing Company, Taipei, ROC, 176-177 (1985 ); (2) Η · Υ · Hsu, Υ · P. Chen, & M. Hong, Chemical composition of Oriental herbs, Oriental Healing Arts Institute, Los Angeles, California, USA, 1400-1401, 1406 (1982); And (3) Y Y. Hsu, YP Chen, & M. Hong, Chemical Composition of Oriental Herbs, Book 2, Oriental Healing Arts Institute, Los Angeles, California, USA, 742 (1985). A mixture of herbs such as honeysuckle, isatis root and forsythia has been used as an antipyretic and antidote and for the treatment of acute hepatitis. Herba Aconitum and Polygonum cuspidatum has been used with other herbs in formulas for the treatment of hepatitis B. Herbal Scutellaria barbata and Ligustrum lucidum -21-(Please read the note on the back first)

The size of the paper is in accordance with the Chinese National Standard (CNS) (210X297 mm) 1232104 A7 B7 V. Description of the invention (19) It is often added with other herbs in the above formula to improve the treatment. Herbal Ligustrum lucidum is often used with other herbs, mainly as a tonic, and the herb Bosch Grass is often used with other herbs as an antidote. The herb prunella is also used with other herbs to relieve liver pressure.

Chang and Yeung screened boiling water extracts of 27 herbs for anti-HIV activity. They found that 11 extracts inhibited HIV in H9 cells. Lonicera japonica, Luzhou prunella vulgaris, single-bud dog ridges and thousands of miles are active substances with moderate activity. Lian Zhao (Forsythia suspensa), Daqingye and Polygonum cuspidatum were those who showed no activity in the test of anti-HIV measurement. In addition, the anti-HIV active extract of Viola yedoensis was tested and found to be quite specific. This extract does not inactivate HIV outside the cells and does not inhibit the growth of herpes simplex, polio or varicella gastritis virus in human fibroblast culture. See R.S. Chang & HW Yeung, Antiviral Research, £, 163-175 (1988) 0 Printed by Syzygium aromaticum, Sapium sebiferum, Huang Zhi and Scutellaria barbata isolates antiviral agents. Syringin (tannin) isolated from clove and methyl tannate isolated from bird's mortar showed anti-herpes simplex virus activity in vitro. Phytoflavonoids, such as 5,7,4f-tricarboxy-8-methoxyflavonoids from the root of Scutellaria baicalensis, and Celery (5,7,4'_trihydroxyflavonoids) from the whole plant Anti-influenza virus activity has been reported. See (1) T. Hozumi et al., U.S. Patent No. 5,411,733 (1995); (2) 1 ^. 丁 31 < ^ 111 & ¥ · Tanaka, Planta Medica, 42-? 69-74 (1981); (3 ) CJM Kane et al., Bioscience Reports, and, 85-94 (1988); and (4) T. Nagai et al., Chem. Pharm. Bull., (5), 1329-1332 (1990) 〇-22- Paper Zhang scale is applicable to Chinese National Standard (CNS) A4 specification (210X297 mm) 1232104 A7 B7 V. Description of invention (20)

Hozmni and other studies have proven 91 kinds of herbs with antiviral activity, more specifically, 52 of them have anti-herpes virus activity, and 64 have anti-polio

I Inflammatory virus activity, 37 species have anti-measles virus activity, 27 species have anti-shingles virus activity, 23 species have anti-CMV activity, and 28 species have anti-DNA virus and anti-RNA virus activity. See T. Hozumi, T. Matsumoto, H. Ooyama, T. Namba, K. Shiraki, M. Hattori, M. Kurokawa, & S. Kadota, U.S. Patent No. 5,411,733, published on May 2, 1995 . The anti-DNA virus and anti-RNA virus activities of the 28 herbs disclosed in the 5,411,733 patent are based on their anti-herpes virus, polio virus, anti-measles virus, and / or anti-herpes virus and anti-CMV active. However, the experiments performed did not find extrapolation covering anti-DNA virus and anti-RNA virus activity. The data of the present invention provided below proves that two herbs derived from the rhizomes of Guanzhong (Cyrtomium · £ 〇1 * 1: 11116 丨) and the bark of Scutellaria baicalensis at 2.5 and 0.5 mg / ml, little or no. -HIV activity. In contrast, three herbal medicines, including the flower spike of Prunella vulgaris, the fruit of forsythia, and the roots and rhizomes of Polygonum cuspidatum, showed strong to moderate anti-HIV activity at 2.5 mg / ml. Luzhou prunella has also been reported by others as very good anti-HIV activity. It should be noted that in traditional Chinese medicine practice, herbal medicine is used to treat the patient's symptoms, not the disease or the pathogen itself, and is therefore known to be non-specific for a particular disease. Herbs are prescribed according to the symptoms of individual patients. The composition of herbal medicines also varies from case to case, and even during treatment, individual patients may be altered depending on the outcome of each treatment. It is therefore difficult to formulate a special herb composition suitable for a particular disease from the prior art. 23- This paper size is in accordance with China National Standard (CNS) A4 (210 X 297 mm). Please read the notes and notes first.

Printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs 1232104 A7 B7 V. Description of the Invention (21) The present invention is directed to the discovery of antiviral herb compositions, their extracts and their active chemical ingredients. The antiviral herb composition of the present invention is obtained from individual herbs, herb compositions, and commercially available Chinese herbal medicines. These novel herb compositions and their extracts and / or active ingredients have been demonstrated herein as antiviral diseases such as HB V and HCV carriers, Hepatitis B, Hepatitis C, HIV infection and AIDS. Brief Description of the Drawings To familiarize those skilled in the art with the principles of the present invention ', reference is made to the accompanying drawings which form a part hereof. Figure 1 is the HPSEC UV side view of No. 5 (5) EA-AP1X, the acid-precipitable active component of No. 5 (5) EA, purified in one form at 214 nm; where No. 5 ( 5) EA is C18-SPE-LC water-soluble eluate of No. 5 (5). Figure 2 is the HPSEC UV side view of No. 5 (5) EC-AP, the acid-precipitable active component of No. 5 (5) EC in acid form, at 214 nm; where No. 5 (5) EC is No. 5 (5) C18-SPE-LC 1% HC1 / water soluble chaotropic fraction. For these two figures 1 and 2, the columns used for HPSEC (High Performance Size Exclusion Chromatography) analysis are Varian MicroPak TSKgel-G3000 PWXL columns (7.8 mm ID x 30 cm long) and TSK PWXL protection columns (6.0 mm The inner diameter (χ4 · 0 cm in length) was connected in series, the mobile phase was 0.1 N NH4HC03, the flow rate was 0.80 ml / min, and the sample was prepared in the mobile phase at 0.92 to 0.93 mg / ml. The injection volume is 100 microliters. Figure 3A is a side view of No. 5 (5) E-Α · AP1X at 214 nm and Figure 3B is a side view of RI. The collected HPSEC parts are shown in 6-18 and 7-12. -24- This paper size applies to Chinese National Standard (CNS) A4 specification (210X297 mm) Please read the note of © ©

Printed by the Consumers 'Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs 1232104 Printed by the Consumers' Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs A7 B7 V. Description of the Invention (22) Figure 4-8 is number 5 (5) £ 01 > 3 £ (: 1; ¥ side view, and Figure 4B is the RI side view. The collected HPSEC part is shown in 6-18 and 7-12. 0 Figure 3 The HPSEC situation of A, 3B, 4A and 4B is as shown above. Figures 1 and 2 except that the sample concentration is 6.1 to 6.2 mg / ml. Figure 5 A is the HPSEC UV side view at 214 nm of HPSEC fraction 8 purified by chromatography, No. 5 (5) E-C_AP And Figure 5B is the RI side view. HPSEC conditions are as described above for Figures 1 and 2, except that the mobile phase is 0.2 N NH4HC03 and the sample concentration is 0.55 mg / ml. Figure 6 A is purified by chromatography Side view of C18-HPLC UV at 214 nm of No. 5 (5) EC-AP HPSEC Part 8, and Figure 6B shows the part of No. 5 (5) EC-AP HPSEC Part 9. Cl8-HPLC (octadecyl HPLC Analytical method) The analytical column was a Rainin Microsorb-MV C18 column (5 micron particles, 100 A pore size, 4.6 mm inner diameter x 25 cm length), and the mobile phase was 0.1 N NH4HC03 containing 30% ethanol, and the flow rate was 0. . 80 ml / min. The sample was prepared in the mobile phase at 1.0 mm / ml and the injection volume was 5 μl. Figure 7 shows the number 5 (5) EA-AP1X-NH4, and the number 5 (5) in the form of ammonium salt. ) HPSEC UV side view of the active component of EA at 214 nm by the purified acid of EA. The HPSEC condition of this figure 7 and the following figures 13 and 17 are the same as those in figures 1 and 2 above, except that the mobile phase contains 30 0.3 N NH4HC03 in% acetonitrile. This sample was prepared in 0.3 N NH4HC03 with a sample concentration of 0.65 mg / ml for Figure 7 and 1.4 mg / ml for Figures 13 and 17. Figure 8 is the number 5 (5) E-AP1X- NH4, No. 5 (5) -25 in the form of ammonium salt ^ This paper ^ size applies to Chinese National Standard (CNS) A4 specification (210X29 * 7 mm) (Please read the precautions on the back first \ ^^^ this page) -Install_ order

Printed by the Consumers' Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs I 1232104 A7 B7 V. Description of the invention (23) HPSEC UV side view of water-extractable and acid-precipitable active components. For this Fig. 8 and the following Figs. 14, 18, 21, 24, and 27, the HPSEC conditions are the same as those in Figs. 1 and 2, except that the sample concentration is 1.0 mg / ml and the injection volume is 50 microliters. Figure 9 is a gradient RP-HPLC UV side view of the water-extractable and acid-precipitable active components of the number 5 (5) E-AP1X-NH4 and number 5 (5) in the form of ammonium salt. For Figure 9 and Figures 15, 19, 22, 25, and 28 below, the columns used for 1 ^ -11? 1 ^ (reverse phase high performance liquid chromatography) analysis were PerSeptive Biosystems · POROS R2 / H columns ( 4.6 mm inner diameter x 10 cm long), the mobile phase is 0.1 N NH4HC03 with ethanol, which changes from 2% to 60% according to the gradient in Table 17, the flow rate is 2.0 ml / min, and the sample is in 2% ethanol Prepared in 0.1 N NH4HC03 with an injection volume of 20 μl. Figure 10A is the U V spectrum of No. 5 (5) E-AP6X, Figure 10B is the UV spectrum of GE-AP6X, and Figure 10C is the UV spectrum of HEAP6X. The UV spectrum of the sample was measured in NH4HC03. No solvent blank correction. Figure 11 shows the IR spectrum of the active component numbered 5 (5) E-AP6X and numbered 5 (5) in the form of water-extractable and acid-precipitable acid. Figure 12 shows the IR spectrum of the water-extractable and acid-precipitable active component of the number 5 (5) E-AP1X-NH4 in the form of an ammonium salt. For Figures 11 and 12, and Figures 16, 20, 23, 26, and 29 below, the IR spectra of each sample were measured in KBr sheets. Figure 13 shows the HPSEC UV side view of GE_AP, the water-extractable and acid-precipitable active component of G in acid form at 214 nm. The HPSEC conditions in this figure and in Figure 17 below are the same as those in Figure 7 above, except that the sample concentration is 1.4 mg / _-26 -__ This paper size applies the Chinese National Standard (CNS) A4 specification (210X297 mm) (please first (Read the notes on the back page)

-Order 1232104 A7 B7 V. Description of the invention (24) ml. Figure 14 shows the HPSEC UV side view of GE-AP2X-NHU, the water-extractable and acid-precipitable active ingredient of G in the form of ammonium salt. The HPSEC conditions in this figure are the same as those in Figure 8 above. Figure 15 is a gradient RP-HPLC UV side view of the water-extractable and acid-precipitable active components of G-AP2X-NHU in the form of ammonium salt G. The gradient RP-HPLC conditions in this figure are the same as those in Figure 9 above. Figure 16 shows the IR spectrum of the active components of GE-AP2X-NH4, water-extractable and acid-precipitable G in the form of ammonium salt. Figure 17 shows the HPSECUV side view of HE-AP, the active component of water-extractable and acid-precipitable tritium in acid form at 214 nm. The HPSEC conditions in this figure are as shown in Figure 13 above. Figure 18 is a HPSEC UV side view of the water-extractable and acid-precipitable active components of tritium in the form of ammonium salt of HE-AP1X-NKU. The HPSEC conditions in this figure are as shown in Figure 8 above. Figure 19 is a gradient RP-HPLC UV side view of HE-AP1X-NH4, a water-extractable and acid-precipitable active component of amidine in the form of ammonium salt. The gradient RP-HPLC conditions in this figure are similar to those in Figure 9 above. Printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs (please read the precautions on the back \ ^! ^ This page) Figure 20 is the water extractable and acid-precipitable activity of ΗΕ-ΑΡ1χ-ΝΗ4 as ammonium salt IR spectrum of components. Figure 21 is a HPSEC UV side view of the water-extractable and acid-precipitable active component of No. 5 (8) E-AP1X_ΝΗ4, No. 5 (8) in the form of ammonium salt. The HPSEC conditions in this figure are as shown in Figure 8 above. Figure 2 2 is No. 5 (8) E-AP1X-NH4, No. 5 (8) -27 in the form of ammonium salt- This paper size applies to China National Standard (CNS) A4 (210X297 mm) 1232104 A7 B7 V. Description of the invention (25) A gradient RP-HPLC UV side view of water-extractable and acid-precipitable active components. The gradient conditions in this figure are the same as those in Figure 9 above. Figure 23 shows the IR spectrum of the water-extractable and acid-precipitable active component numbered 5 (8) E-AP1X-NH4 in the form of ammonium salt and numbered 5 (8). Figure 24 is a HPSEC UV side view of the water-extractable and acid-precipitable active component of No. 5 (11) E · AP1X · ΝΗ4, No. 5 (11) in the form of ammonium salt. The HPSEC conditions in this figure are as shown in Figure 8 above. Figure 25 is a gradient RP-HPLC UV side view of the water-extractable and acid-precipitable active component of No. 5 (11) E-AP1X-ΝΗ4, No. 5 (11) in the form of ammonium salt. The gradient RP-HPLC of this figure is as shown in Figure 9 above. FIG. 26 is an IR spectrum of a water-extractable and acid-precipitable active component of No. 5 (11) E-AP1X-ΝΗ4, No. 5 (11) in the form of an ammonium salt. Figure 2-7 is the HPSEC UV side view of the water-extractable and acid-precipitable active component of No. 4 (2) E-AP1X-NY4, No. 4 (2) in the form of ammonium salt. The HPSEC conditions in this figure are as shown in Figure 8 above. Figure 28 is a gradient RP-HPLC UV side view of the water-extractable and acid-precipitable active components of No. 4 (2) E-AP1X-NH4, No. 4 (2) in the form of ammonium salt. The gradient RP-HPLC conditions in this figure are as shown in Figure 9 above. Printed by the Consumer Cooperatives of the Central Bureau of Standards of the Ministry of Economic Affairs (please read the precautions on the back and then this page). Figure 29 is the water extractable number 4 (2) E-AP1X-NH4 in the form of ammonium salt. And IR spectra of acid-precipitable active ingredients. One aspect of the present invention is directed to a composition of matter comprising water-extractable and acid-precipitable anti-HIV active components obtained from various Chinese herbal medicines or medicinal plants, of which Figures 1, 2, 5A, 5B, 7, 8 , 13, 14, 17, 18, 2 1, 24 and 27 HPSEC side views; Figure 6 A and 6 B Cl 8-HPLC side -28- This paper size applies to China National Standard (CNS) A4 specifications (2I0X297 (Mm) 1232104 Α7 Β7 Printed by the Consumer Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs 5. Description of the invention (26) Figures; Figures 9, 15, 19, 22, 25, and 28 gradient 10 > -11? 1 ^ side view; Figures UV spectra of 10A, 10B, and 10C; and IR spectra of Figures 11, 12, 16, 20, 23, 26, and 29. Summary of the Invention As used herein and in the scope of the patent application, the following nomenclature is used to confirm that 4 kinds of herbal mixtures are called HHT888-4, HHT888-5, HHT888-45 and HHT888-54 ° HHT888-4 is 5 single Chinese herbal medicines with the number 4 ( 1): No. 4 (2): No. 4 (3): No. 4 (4): No. 4 (5) The preferred ratio is a mixture of about 3: 3: 3: 3: 4 (w / w). The weight ratio of each component can vary up to 50%. " Variation by weight ratio of 50% " means that each component of the ratio can be increased or decreased by 50%. Therefore, as an example, the range of 1: 1 can be from 1 · 5: 0 · 5 to 0 · 5: 1 · 5 (or 3: 1 to 1: 3). The 11 single Chinese herbal medicines of HHT888-5, a mixture of No. 5 (1) to No. 5 (11), preferably in approximately equal weight proportions. The weight ratio of each component can vary up to 50%. HHT888-45 is a mixture of 4 to 6 single Chinese herbal medicines, numbered 4 (3): 4 (4): 5 (4): 5 (5): 5 (8): 4 (2) The preferred ratio is about 1: 1: 1: 1: 0-1: 0-1 (w / w). The weight ratio for each component can be changed up to 50%. HHT888-54 is number 5 (5) or Η and at least one selected from number 4 (2), number 4 (3), number 4 (4), number 4 (5), number 5 (1), number 5 ( 2), a mixture of single herbs of No. 5 (4), No. 5 (7), No. 5 (8), and No. 5 (11), among which the preferred weight ratio of No. 5 (5) or tincture to other single herbs For -29- This paper size applies the Chinese National Standard (CNS) A4 specification (210 X 297 mm) (please read the precautions on the back before this education) Order-Quan 1232104 A7 B7 V. Description of the invention (27) 1 " . Therefore, in the preferred embodiment, HHT888-54 consists of number 5 (5) or Η plus number 4 (3), number 4 (4), number 5 (8), and number 5 (11); preferred weight The ratio is 1: 1: 1: 1: 1. More generally, the weight ratio of number 5 (5) or tincture to the sum of other single herbs is 1:10 to 10: 1. The single herbal component of YT888-4 is: No. 4 (1) = Bozhijiacao (also known as Hedyotis diffusa) Source · Hedyotis diffusa (also known as Oldenlandia diffusa) No. 4 (2 ) = Scutellaria barbata source: Scutellaria barbata, Scutellaria rivularis, Scutellaria dependens No. 4 (3) = Honeysuckle source: Honeysuckle, Earth honeysuckle No. 4 (4 ) = Prunella vulgaris source: Yuzhou prunella vulgaris, Japan prunella vulgaris (Prunella vulgaris subsp. Asiatica) (also known as Prunella vulgaris var. Lilachina) Printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs No. 4 (5) = Dragon sunflower : The single herbal component of Solanumnigrum HHT888-5 is: No. 5 (1) = Bozhijiacao (also known as Hedyotis diffusa) Source · Hedyotis diffusa (also known as Oldenlandia diffusa) 30- This paper size is applicable to China; ^ (CNS) A4 size (210X297 mm) 1232104 Α7 Β7 Printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs 5. Description of the invention (28) No. 5 (2) = Consistent Public or Northeast Guanzhong (〇1 ^ 0? 丁 £ 1118 011 eight 881111120-MAE RHIZOMA) Source: Black hair fern, Northeast Guanzhong, Wei, Woodwardia orientalis, Single bud dog ridge, Athyrium acrostichoides, Taiwan Sphaeropteris lepifera, Cyrtomium falcatum, Cyrtomium fortunei number 5 (3) = CIRSII RHIZOMA ET RADIX and BREEAE RADIX Source: Cirsium japonicum, Cirsium albescens, Cirsium japonicum var. australe, Brea segetum (also known as Cephalanoplos segetum), Breea setosum number 5 (4) = night-closing door or source of senecio · Lespedeza cuneata, Senecio scandens number 5 (5) = Government cancer source: wild cricket number 5 (6) = Banlangen sources: Daqingye, Malan, Isatis tinctoria, Banlangen (13 & 1 ^ 丨 11 (^ 8 (^ 03), Qingdai number 5 ( 7) = Polygonum cuspidatum source: Polygonum cuspidatum, Dokawachi, Japanese Polygonum cuspidatum (also known as Reynoutria japonica) -31-Exactly, the scale of the scale is applicable to the Chinese National Standard (CNS) A4 specification (21〇χ297 male thin)

1232104 A7 B7 V. Description of the invention (29) No. 5 (8) = Forsythia Source: Forsythia, Admiralty, Korean Forsythia No. 5 (9) = Scutellaria Source: Guan Huanghua, Chuan Huanghua, Yueben Huanghua, Scutellaria baicalensis No. 5 (10) = Source of Bai Zhi: Source of Bai Zhi No. 5 (11) = Source of Ligustrum lucidum, Ligustrum lucidum, Ligustrum lucidum HHT888-45 The single herbal component is: No. 4 (3) = Honeysuckle Source: Honeysuckle, Earth Honeysuckle No. 4 (4) = Source of Prunella vulgaris · Luzhou Prunella vulgaris, Japanese Prunella vulgaris (also known as Prunella vulgaris var. Lilachina) No. 5 (4) = Night Close Door or Senecio Source: Closed at night, Senecio number 5 (5) == Printed by the Consumers' Cooperative of the Central Standards Bureau of the Ministry of Economy and Economics. Source: Nojiri No. 4 (2) = Scutellaria barbata. Source: Scutellaria barbata. Zhilian (Scutellaria rivularis), Cynodon dactylon No. 5 (8) = Forsythia Source: Lianmei, Admiralty, Han Liangui -32- This paper size applies to China National Standard (CNS) A4 (210X297) 1232104 A7 B7 Five 'Invention Note (30.) printed by the Consumers' Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs (30.) The single herbal component of HHT888_54 is No. 5 (5) = Guanyuan Source: Wild pheasant = Horseshoe gold. Source: Steamed moss or horseshoe gold (Dichondra micrantha) and at least one of the following: No. 4 (2) = Scutellaria source: Banzhi Lotus (Scutellaria barbata), Scutellariarivularis, Cynodon dactylon No. 4 (3) = Honeysuckle Source: Honeysuckle, Earth Honeysuckle No. 4 (4) = Prunella Source: i Except Prunella, Japan Prunella vulgaris (also known as Prunella vulgaris var. Lilachina) Number 4 (5) = Dragon Sunflower Source: Dragon Sunflower No. 5 (1) = Bozhijia grass (also known as White Flower Hedyotis) Source: White Flower Hedyotis ( (Also known as Oldenlandia diffusa) No. 5 (2) == Guanzhong or Northeast Guanzhong Sources: Black hair fern, Northeast Guanzhong, Wei, Woodwardia odentalis, Single bud ridge, North China Guanzhong, Taiwan Guanzhong, Guanzhong number 5 (4) == Night Closing Door or Trinidad Light Source: Night Closing Door, Trinidad Light -33- This paper size applies to Chinese National Standard (CNS) A4 specification (21〇X 297 mm) (Please read the precautions on the back first (This page) I installed · Taidang 1232104 A7 B7 The seal of consumer cooperation of employees of the Central Bureau of Standards of the Ministry of Economic Affairs — V. Invention (31) No. 5 (7) = Polygonum cuspidatum ·· Polygonum cuspidatum, No.7, Japanese knotweed No. 5 (8) = Forsythia source: Lian Wei, Admiralty flower, Han Lianfan * No. 5 (11) = Ligustrum lucidum source: Ligustrum lucidum and Ligustrum lucidum should note that number 4 (1) is the same as number 5 (1) (Bo Zhijia Cao). For a single herbal component, the name of the herbal medicine is shown in uppercase, followed by its plant source in italics. As used herein and in the scope of the patent application, the terms HHT888-4, HHT888-5, HHT888-45, and HHT888-54 include the Zhengzheng herbal mixture, its water extract, and the active components or ingredients of the extract. In a similar manner, the use of terms such as number 5 (5), number 5 (8) and the like includes tincture of herbs, extracts thereof and agents of isolated active molecules. As it is also used in patent specifications and patent applications, G is wild weed or number 5 (5), number 4 (2), number 4 (3), number 4 (4), number 4 (5), number 5 (1), number 5 (2), number 5 (3), number 5 (4), number 5 (5), number 5 (6), number 5 (7), number 5 (8), number 5 (9), No. 5 (10), No. 5 (11), and the base plants are the above-mentioned single herb herbal components, including their respective base plants. The above special descriptions of Chinese herbs and herbs can be found in the following references: (1) H. C Chang, Medical Herbs I, Holiday Publishing Company, Taipei, Taiwan, ROC ·, 15, 36, 100, 113, 127, 147 ( (1990); (2) HC Chang, Medicinal Herbs II, Holiday Publishing Company 'Taipei' -34- (Please read the precautions on the back page first) Installation, 1T This paper size is applicable to Chinese National Standards (CNs) M specifications ( 210X 297 mm) 1232104 Printed by the Consumer Cooperatives of the Central Government Bureau of the Ministry of Economic Affairs A7 Β7 V. Invention Description (32) Taiwan, ROC ·, 15, 27, 131, 135, 155 (1991); (3) WS Kan, Pharmaceutical Botany, National Institute of Chinese Medicine, Taipei, Taiwan, ROC, 113, 124-130, 200-201, 206-207, 289-290, 353-354, 442-444, 460-461, 485, 487-488 , 497, 505, 513-514, 522, 527-529, 558, 562-563, 648-649 (1971); (4) M · S · Lee Handbook of Common Chinese Herbal Medicine and Folk Medicine, 12th edition, Sheng-Chang Medicinal Record Magazine, Taipei, Taiwan, ROC ·, 4-6, 17, 21, 29, 36, 38, 40, 48, 58, 64, 71, 79, 85 (1992) and (5) Η · Υ · Hsu, Y. P. Chen, SG Hsu, JS Hsu, CJ Chen, & HC Chang, Concise Pharmacognosy, New Medicine Publishing Company, Taipei, Taiwan, 11.0. (:. , 90, 97, 105-106, 117-118, 126-127, 130-131, 133, 138, 144-145, 152-153, 156-157, 161-162, 174, 176-177, 357-358 , 381-382, 384-385, 456-457, 577-578 (1985). In its broadest aspects, the present invention relates to the use of said herbal mixtures and their use in the prevention and treatment of viral infections. The present invention also A novel blend of herbs and herbs derived from them. For example, named as HHT888-4, HHT888-5, HHT888-45, HHT888-54, number 5 (5) -H, number 5 (5) -number 4 (3), number 5 (5) -number 4 ( 4), number 4 (3) -number 4 (4), number 5 (5) -number 5 (11), H-number 4 (4), H-number 4 (3), H-number 4 (5 ), H-No. 5 (8), H-No. 5 (11), herbal mixtures, mixtures thereof and pharmaceutically acceptable salts thereof. More specifically, viral infections are caused by HB V, HCV, and HIV. The antiviral mixtures according to the present invention have been described above as HHT888-4, HHT888-5, HHT888-45 and ΗΗ888 · 54. In addition, it is named No. 4 (2), No. 4 (5), No. 5 (5), No.-35- This paper ^ size applies to China National Standard (CNS) Α4 specification (210 × 297 mm) '(Please read first Note on the back page) • Equipment · 1T 1232104 A7

1232104 Α7 Β7 V. Description of the invention (34) 11 of the 15 single herb components of HHT888-4 and HHT888-5, that is, number 4 (2), number 4 (3), number 4 (4), number 4 (5), number 5 (1), number 5 (2), number 5 (4), number 5 (5), number 5 (7), number 5 (8), number 5 (11), and herb loan Inhibits virus proliferation in HIV-infected human peripheral blood lymphocytes (PBLs). This model highly predicts anti-HIB activity in vivo. The water extract of the single herb herbal component No. 5 (5), prepared directly from its source plant wild pheasant, has shown good anti-HIV activity. In addition, the water extracts of the single herb components No. 4 (3), No. 4 (4) and No. 5 (11) have shown moderate to strong anti-HIV activity. The water extracts of single herb components No. 4 (2), No. 4 (5), No. 5 (1), No. 5 (sentences and No. 5 (8) only show weak anti-HIV activity. No. 4 (2) The water-extractable and acid-precipitable components of No. 4 (5), No. 5 (1), No. 5 (5), No. 5 (8), and Tritium are shown herein as effective anti-HIV agents. Similar Water-extractable and acid-precipitable components have also been isolated from numbers 4 (4) and 5 (11) and are shown herein as anti-HIV. These water-extractable and acid-precipitable anti-HIV active groups The copies are similar, not previously described, and are novel and unknown. Printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs (please read the note on the back page first) Water Extractable and Acid Soluble Anti-HIV Active Group Portions have also been separated from numbers 4 (4) and 5 (11). The water-extractable and acid-soluble components of number 5 (11) have not been previously described and are novel. Water of number 4 (4) may be Extracted and acid-soluble active ingredients can be the same as previously described partially sulfated polysaccharides or prunella saponins. Only one active ingredient is isolated from the water extract number 4 (3), which is soluble in acid. -37- Paper The scale is applicable to the Chinese National Standard (CNS) A4 specification (210 × 297 mm) 1232104 A7 B7 V. Description of the invention (35 Compositions of other disclosed substances, herb mixtures HHT888-4, HHT888-5, HHT888-45 and HHT888-54. The composition of these substances has not been previously described and is unknown. It is also disclosed that the substance composition contains at least one herb from a single herb or is selected from: No. 4 (2), No. 4 (4), No. 4 (5) , No. 5 (1), No. 5 (5), No. 5 (8), No. 5 (11), and Η source plants are separated or mixed to separate water-extractable and acid-precipitable anti-HIV active groups The composition of these substances has not been previously described and is unknown and novel. The composition of this substance is used for the treatment of viral infections. Therefore, a method of treating a viral infection in mammals is also disclosed, the method At least one composition comprising a therapeutically effective amount (e.g., 0.4 to 120 grams per day) of the mammal is selected from the group consisting of ΗΗ888-4, ΗΗ888-5, ΗΗ888-45, ΗΗ888-54, number 4 (2), number 4 ( 5), number 5 (1), number 5 (2), number 5 (4), No. 5 (5), No. 5 (7), No. 5 (8), No. 5 (11), and Rhenium and their respective extracts or active ingredients. More specifically, reveal viruses that reduce HBV-infected humans A loading method comprising administering to a human a therapeutically effective amount (e.g., 0.4 to 120 grams per day) of a composition including ΗΗ888-5 or an extract derived from ΗΗ888-5. It also discloses treatment of humans infected with HCN. A method comprising administering to the human a therapeutically effective amount (eg, 0.4 to 120 grams per day) of a composition containing HT888-45 or an extract obtained from HT888-45. It also discloses a method for reducing the viral load of a human carrier of HBV, and a method for treating or preventing human hepatitis B, which method includes administering to that person 38- This paper size applies the Chinese National Standard (CNS) A4 specification ( 210 X 297 mm) Please read the precautionary page of © © Printed by the Consumer Standards Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs 1232104 A7 Invention Description (36 Printed effective amounts of the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs (such as 0.4 every day To 120 g) at least one composition selected from the number 5 (5) and at least one composition selected from the number 5 (1), the number 5 (2), the number 5 (3), the number 5 (4), and the number 5 (6 ), No. 5 (7), No. 5 (8), No. 5 (9), No. 5 (10) and No. 5 (11). In addition, the method of treating HCV carriers and the treatment or prevention of human type C Method of Hepatitis' The method comprises administering to the human a therapeutically effective amount (eg, 0.4 to 120 grams per day) of a composition comprising a single herb herbal number 5 (5), an extract or active ingredient thereof and at least one single herb herbal , Its extract or active ingredient is selected from number 4 (2), number 4 (3), number 4 (4) A mixture of No. 5 (4), No. 5 (8), and No. 5 (11). Also disclosed is a method for treating human hepatitis B, which method comprises administering to a human a therapeutically effective amount (such as 0 to 12 per day) 〇)) at least one selected from the group consisting of ΗΗ888-45 and ΗΗ888-5. Also disclosed is a method for treating human hepatitis B, which method comprises administering to the human a therapeutically effective amount (such as 0.4 to 120 grams per day) At least one composition is selected from the group consisting of (1) single herb herbal medicine No. 5 (5), its extract or active ingredient and at least one single herb herbal medicine, its extract or active ingredient (selected from No. 4 (2), number A mixture of 4 (3), No. 4 (4), No. 5 (4), No. 5 (8), and No. 5 (H)); and (2) Single herb herbal medicine No. 5 (5), its extract Or active ingredient and at least one single herb herbal medicine, its extract or active ingredient (selected from No. 5 (1), No. 5 (2), No. 5 (3), No. 5 (4), No. 5 (6) , No. 5 (7), No. 5 (8), No. 5 (9), No. 5 (10), and No. 5 (11)). In addition, a method for treating humans infected with HIV is disclosed. The method includes Cast _ -39- (Please (Read the notes on the back page) — One 'binding · binding • I .......!.?-· Exactly, · The common Chinese National Standard (CNS) 8th and 4th secrets (210X297 mm) 1232104 A7 B7 V. Description of the invention (37) A method for administering to a human a therapeutically effective amount (such as 0.4 to 120 grams per day) of a composition comprising HHT888-4. A method for treating a human infected with HIV is disclosed, which comprises administering to the human a therapeutically effective amount (e.g., 0.4 to 120 grams per day) of a composition comprising HHT888_5. A method is disclosed for treating HIV infection, which method comprises administering to the human a therapeutically effective amount (e.g., 0.4 to 120 grams per day) of a composition comprising HHT888-45. A method for treating a human infected with HIV, HBV, and HCV is disclosed, which comprises administering to the human a therapeutically effective amount (e.g., 0.4 to 120 grams per day) of a composition comprising HT888-54. Also disclosed is a method of treating a human infected with HIV, which method comprises administering to the human a therapeutically effective amount of a composition comprising at least one single herb herbal medicine, an extract or an active ingredient thereof (selected from No. 4 (2), (No. 4 (5), No. 5 (1), No. 5 (2), No. 5 (4), No. 5 (5), No. 5 (7), No. 5 (8), No. 5 (11), and Η) . Also disclosed are novel herb mixtures and methods of treating HIV-infected humans, the methods comprising administering to the human a therapeutically effective amount of the herb mixture comprising at least one herb selected from the number 5 (5) and mixtures thereof, and at least One herb is selected from the number 4 (2), the number 4 (3), the number 4 (4), the number 4 (5), the number 5 (1), the number 5 (2), the number 5 (4), and the number 5 (7), No. 5 (8), No. 5 (11). Also disclosed is a method for treating a human infected with HIV, which method comprises administering to the human a therapeutically effective amount of a mixture comprising at least two Anti-disease-40- This paper size is applicable to Chinese National Standard (CNS) A4 (210X297mm) Please read the notes on the back first. Printed by the Consumers' Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs 1232104 V. Invention Description (38 Ministry of Economic Affairs) The Central Standard Bureau employee consumer cooperative prints the parent component, which is derived from a single herb or its source plant selected from the number 4 (2), number 4 (3), number 4⑷, number 4 (5), and number 5 ( 1), number 5 (2), number 5⑷, number 5 (5), number 5⑺, number 5⑺, number 5 (11), and Η are separated 'Also disclosed is a method for treating a human infected with HIV, which method comprises administering to the human a therapeutically effective amount of a composition comprising at least one herb from a single herb or selected from the group consisting of No. 4 (2), No. 4⑷, No. 4 (5), No. 5 (1), No. 5 ^ 5), No. 5⑻, No. 5 (11), water-extractable and acid-precipitable antiviral components or compounds isolated from the source plant. Therefore, the present invention is directed to: a composition of υ substances (that is, a mixture of herbs and isolated chemical entities); 2) a method for treating ΗΒν and Hcv carriers; 3) prevention and treatment of hepatitis B and hepatitis C; 4 ) Treating the audiophile; and 5) preventing and treating AIDS by administering the composition according to the present invention. 0 The dosage of the composition according to the present invention may range from 0.4 to 120 grams per day for mammals to be treated. Those skilled in the art need to understand that depending on the individual's weight and the progress of the viral infection, higher doses of the composition may be required. Since the composition according to the present invention has been proven to have almost no side effects, a high dose can be used, and the dose can be reduced after showing efficacy (i.e., reducing viral load). Those who are proficient in this way can increase or decrease the proportion of each dose without undue experience for a given individual. More specifically, the dosage for a given composition may range from 0.4 to 100 grams per day, and more preferably 10 to 25 grams per day. Preferably, these compositions are administered at least three times per day, however, bolus administration is effective. More specifically, HHT888_5 has been delivered at a dose of 5.5 grams orally 3 times a day (a total of 165 grams per day) (please read the precautionary page on the back first) -Packing ·, ^ τ • I;-In «n 1 ^ 1 · -41 1232104 A7 B7 printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs 5. Description of the invention (39) The HBV load of the carriers has been effectively reduced. Oral administration of 2.7 · 5 · 7 grams of grass mixture JJHT888-45 3 times a day (8-17 grams a day) has been found to be effective in restoring normal liver function in patients with hepatitis C. No serious side effects have been demonstrated for JJHT888-5 up to 121 grams per day and for 63 grams per day of HT888-45. It should be understood that the dosages described herein are for the herb in dry form (the extract is attached to the ground plant or adsorbent). In addition, the extract of the composition of the present invention increases the concentration of the active substance, so it is necessary to understand that the dosage is reduced. Dosages as low as 10% of those described in the compositions of the invention are encompassed. For a preferred dose of No. 5 (5) for the treatment of HCV infection, from 0.4 to 17 grams per day. The composition of the invention is preferably administered orally or enterally, however, intravenous (iv) and / or intramuscular (i.m.) administration is also encompassed herein. Those skilled in the art need to know how to prepare i.v. and i.m. formulations and how to obtain effective doses. In the method according to the invention, the mammals can be humans or animals. Humans can be adults, children or infants. Therefore, for infants, infant formulas containing the plant extracts or active ingredients described below are effective for treating infants infected with HBV, HCV or HIV. For children and adults, medicinal foods or nutritional products, such as cow's milk and yogurt, containing the plant extracts or active ingredients described herein are also effective in treating humans infected with HBV, HCV or HIV. The invention also relates to the isolation of effective compounds from said herbs or medicinal plants and the isolated compounds themselves. The herb used as the starting material of the present invention can be obtained from commercial sources, and it is a single herb herb 'which can be mixed, or extracted and concentrated, and placed in a composition for administration to humans. Plant extract, once separated from plant material, can be concentrated and placed again -42- This paper size applies Chinese National Standard (CNS) A # specification (21〇 > < 297mm) (Please read the notes on the back first to write this Page) • Loading ·

1T 1232104 Printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs A7 B7 V. Description of the invention (40) In a form suitable for administration to humans (ie pills, capsules and lozenges). Once the active ingredient is isolated or synthesized from the plant, it can be placed in a composition for administration to humans, and can take various forms such as capsules, lozenges, powders, confections, gels, beverages, tea, nutrition products and the like. It is also disclosed that it is a pharmaceutical product manufactured by a method including the following steps: (a) crushed plant materials such as numbers 5 (1) to 5 (11), numbers 4 (2) to 4 (5), Η , And its mixture in contact with water to form an aqueous dispersion; (b) heating the aqueous dispersion to about 001 and maintaining the temperature at about 0.5 to about 3 hours; (0 insoluble plant material separated from the aqueous phase, and; and (D) Concentrate the solute contained in the aqueous phase. The concentrated solute is obtained by freeze-drying, spray-drying, evaporation or ultrafiltration. It is also disclosed that the pharmaceutical product is manufactured by a method including the following steps: (a) will be selected From number 4 (2), number 4 (4), number 4 (5), number 5 (1), number 5 (5), number 5 (8), number 5 (11), 编号, and mixtures thereof Crush the plant material 'in contact with water to form an aqueous dispersion; (b) heating the aqueous dispersion to about j ° C and maintaining the temperature at about 0.05 to about 3 hours; (c) separating the insoluble plant material from the aqueous phase; d) acidifying an aqueous solution with an acid (such as HC1) to a pH of less than about 2.0; (e) separating the acid precipitate from the supernatant; and (f) purifying the acid by dissolving in an alkaline solution (such as 0.1 N NHUHCO3) sink The precipitate is reprecipitated with acid. Depending on the situation, the acid precipitate can be dissolved in a 0.1N NH4HC03 solution and concentrated. The concentrated solute can be obtained by freeze-drying, spray-drying, evaporation or ultrafiltration. Used for acidified water extraction Representatives of acid acids include HC1, H3P04, Bing Yicao, HjO4, etc. It is important that the acid has sufficient pKa to convert the active component into acid form. The pH of the extract should be less than 3.0 and optimally Less than 2.0 for -43-

Han Gong 1232104 V. Description of the invention (41 Precipitation occurred. It is also disclosed that the pharmaceutical product is manufactured by a method including the following steps: (a) will be selected from: No. 4 (2), No. 4 (4), No. 4 (5 ), No. 5 (1), No. 5 (5), No. 5 (8), No. 5 (11), at least one herb of the tincture and its mixture is contacted with water to form an aqueous dispersion; (b) the aqueous dispersion is Stir at ambient temperature for about 0.5 to about 3 hours; (c) separate insoluble plant material from the water phase; item (d) acidify the aqueous solution with acid to less than about 20 ipH to form a precipitate; (e) self-acid The supernatant was used to separate the acid precipitate; and (f) the acid precipitate was purified, and the precipitate was separately dissolved in a 1N NH4HC03 solution and purified by reprecipitating with acid. This application is described in the present invention. Data, and fully describe the composition of the material, their preparation, clinical application and analytical tools for the specificization of various active groups. These and other aspects of the invention will be apparent from the following examples. In this regard, the following examples are intended to illustrate, but not to limit, the invention. In order for those skilled in the art to understand the principles of the present invention, the following examples are presented for illustration and not limitation. All percentages, unless otherwise specified, are weight ratios. Example 1 Herbal mixture: In the preparation of the herb composition according to the present invention , From commercial sources in powder form through the single herb type herbal medicines. Individual single herb herbal medicines are mixed in appropriate proportions to prepare each herb mixture. -44- This paper is suitable for χ 297 mm 1232104 A7 B7 V. Description of the invention (42) Mix 3: 3: 3: 3: 4 by weight ratio No. 4 (1), No. 4 (2), No. 4 (3), No. 4 (4) and No. 4 (5) to prepare HHT888-4. Herbal mixture. The preparation of the herbal mixture HHT888-5 is performed by assigning equal weights to No. 5 (1), No. 5 (2), No. 5 (3), No. 5 (4), No. 5 (5), No. 5 (6), No. 5 (7), No. 5 (8), No. 5 (9), No. 5 (10), and No. 5 (11) are mixed. The preparation of the herb mixture HHT888-45 is based on 4 to 6 single herbs Herbs No. 4 (3), No. 4 (4), No. 5 (4), No. 5 (5), No. 5 (8), and No. 4 (2) in proportion of mi: 0-l: 0-l by weight Mixed. Some feelings in HHT888-45 In the initial administration, no single herb herbal number 5 (8) or number 4 (2), or both were used. Later, when the treatment needs to be improved, one or both of the two single herbal herbs are added. In the herb mixture HHT888 The weight ratio of the single herb herbal medicine number 4 (2) in -45, when used, varies between 0.5 and 1 depending on the situation. It is to be noted that individual decoction mixtures prepared from the source plants of the single herb herbal medicine or from each The decoction of a single herb component of a herb mixture from a premixed source plant is within the scope of the present invention. Example 2 Preparation of Mono-herb Herbs The plant sources from which each single-herb herb was obtained are listed in the previous techniques and summary section of this application. It should be understood that more than one species or genus of medicinal plants can be used to make the same herb. For example, herbal number 5 (8) or forsythia (FORS ΥΊΉΙΑΕ FRUCTUS) can be prepared from three species of forsythia genus, also gp lianwei, fuchsia, hanlianqu or mixtures thereof. Herb No. 5 (6) (Board -45- This paper size is applicable to Chinese National Standard (CNS) A4 specification (210X: 297 mm) (Please read the precautions on the back first. Installation-Zero Horse Page)

1T printed by the Consumer Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs 1232104 printed by the Consumer Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs A7 B7 V. Description of the invention (43) Fish (BAPHICACANTHIS RHIZOMA ET RADIX) can be prepared from 5 plants Isatis root, horse blue, daqing, isatis indigotica), indigo or a mixture thereof. Herbal medicines are prepared from their respective plant sources as follows. The appropriate part or whole grass is obtained, washed with cold water, dried and crushed. The plant material is then extracted with boiling water, and about 5 to 10 parts by weight of water are based on 1 part by weight of the plant material. The amount of water used covers at least the plant material in the extraction container. Boil the sample for 0.5 to 1 hour, but not more than 3 hours, so as to effectively extract the injury of the team. Shorter or longer heating does not substantially affect extraction, except for yield and cost. The aqueous solution was separated from the plant material by filtration. The aqueous solution can be freeze-dried or spray-dried, or reduced by heating with or without application. The concentrate can be spray-dried or freeze-dried or absorbed in the powder form of the same plant material, starch or other absorbent. Therefore, a single herb herb is prepared. The decoction is an aqueous solution of plant material, which is prepared by boiling the plant material in water for about 0.5 to 1 hour as described above. The decoction can be taken directly after preparation and cooling to a warm or weekly temperature or stored in a suitable sterilizer for later consumption. Sterilization can be accomplished by microfiltration or heating. Example 3 Treatment of Hepatitis B Virus Vector with Normal Serum Glucosamine Acetoacetate Acetyltransferase (sgot) and Glutamate Pyruvate Transferase (SGPT) (Liver Enzyme) 29 HB V Bands The original, treated with HHT888-5. Several HBV carriers with increased SGOT and SGPT content were first treated with other drugs to restore their serum liver enzymes to normal levels -46- This paper is compliant with China National Standard (CNS) A4 specifications (210X297) ) ~ '

1232104 A7 B7 5. Description of the invention (44) The amount (SGOT of 8-40 units / ml and SGPT of 5-35 units / ml) cannot reduce the HBV load. Resume treatment with HHT888-5. HHT888-5 was prepared as described in Example 1 by mixing 11 monoherb herbs obtained from commercial sources and then manufacturing according to Good Manufacturing Practices (GMP). Prior to each patient's treatment, their consent was obtained. The patients were instructed to take HHT888-5 3 times a day, each dose being 5.5 grams. Each 5.5-gram packet of the herb mixture was mixed with warm water and taken orally. At intervals shown in Table 1, each patient measured the serum hepatitis B surface antigen (HBsAg) titer and monitored the progress of treatment. The serum HBsAg titer was determined using the reverse passive hemagglutination test as follows: (1) Instruction of nTaifu " Serodia-HBs Test Reagent for HBsAg Detection, Taifu Pharmaceutical Co., Taoyuan, Taiwan, R_0.C ·; (2) DS Chen & JL Sung, J. Formosan Med. Assoc., 77, 263-270 (1978); and (3) T. Juji & T. Yokochi, Japan, J. Exp. Med., 3_9? 615-620 (1969) ° Table 1 shows the results of treatment of 29 HBV carriers. Patients show improvement in disease status during treatment, as indicated by their reduced HBsAg titer and tranquility. Fourteen carriers (48%) had HBsAg titers in the range of 20 to 81,920. After 35 to 964 days of treatment, the HBsAg titers were significantly reduced (4- to 256-fold reduction, or changed from positive to negative). Four carriers (14%) reduced their HBsAg titer (after 56-153 days of treatment), from 20, 40, and 2,560 to negative (ie, less than 20 nanograms per milliliter). 14 HBsAg titers (48%) had no significant change in the HBsAg titer during the treatment period (63-284 days) (2-fold titer decreased or increased or unchanged). The original (3%) in the belt has a 4 times increase in value. 0 -47- This paper size is applicable to the Chinese National Standard (CNS) A4 specification (210X297 mm). Please read the back notice first.

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7 7 AB V. Description of the invention (45) Table 1 Clinical effect of HHT888-5 on hepatitis B virus carriers. HBsAG titer. After treatment period before treatment (say) 1 40 negative 56 2 2560 negative 72 3 20 negative 153 4 20 negative 88 5 2560 80 53 6 1280 320 101 7 2560 1280 32 1280 399 320 964 8 2560 1280 79 640 412 9 20480 5120 53 10 20480 5120 60 11 40960 10240 35 12 81920 40960 74 10240 461 13 81920 20480 63 14 5120 2560 170 2560 245 1280 556 1280 832 15 160 80 284 16 320 160 198 17 640 320 276 18 1280 640 120 19 2560 1280 69 20 5120 2560 263 21 20480 10240 77 22 40960 40960 120 20480 210 Staff Consumer Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs Printed (Please read the note on the back page first) -48- This paper size is applicable to Chinese National Standard (CNS) A4 (210X297 mm) 1232104 A7 V. Description of the invention (46) The period after treatment (days) before treatment ) 23 160 160 227 24 320 320 79 25 640 640 157 26 1280 1280 69 27 40960 40960 137 28 5120 10240 63 29 160 640 121 here The embodiment of HHT888-5 and the currently accepted treatment comparison of interferon therapy is advantageous. The proportion of interferon therapy and HHT888-5 treatment that reduced the HBsAg titer in patients with HBV infection was comparable, about 40% to 48%, respectively. The serum HBsAg clearance rate of the two is also comparable. Interferon therapy is 10-15%, and HHT888-5 is about 14%. In addition, interferon therapy is typically administered intramuscularly or intravenously, often with adverse effects. . HHT888-5 is administered orally (eg, drinking tea) in all patients treated without significant side effects. Oral is much more convenient and more economical than intramuscular or intravenous administration. Therefore, HHT888-5 can safely and conveniently reduce or control the proliferation of HB V in HB V carriers and patients with hepatitis B even after long-term administration. Printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs (please read the precautionary page on the back). When the HBV virus is reduced or maintained at a sufficiently low level in the HBV carrier, the carrier will proceed to hepatitis, liver Sclerosis, liver cancer, and death are much less likely. Therefore, HHT888-5 can be used to prevent and treat hepatitis B, or even avoid cirrhosis or liver cancer caused by HBV infection. Therefore, in this example, HHT888-5 is effective in treating HBV by first mixing the powder in water and then orally, separating the active component of HHT888-5 and then administering it to humans. The dosage of the herbal mixture HHT888-5 up to 120 grams per day has been completed without serious side effects. -49- This paper size is applicable to Chinese National Standard (CNS) A4 specification (21 ×; 297 mm) 1232104 A7 B7 V. Description of the invention (47) Example 4 Anti-retroviral test of medicinal tincture mixture and its water extract In this example, two herb mixtures, HHT888-4 and HHT888 · 5, were tested for anti-retroviral activity and found to be active against EmuLV and HIV in an in vitro assay. The anti-retroviral activity of the composition of the present invention was tested in two in vitro assays using anti-Ecotropic murine leukemia virus (anti-EMuLV) and anti-HIV. The anti-EMuLV assay uses a large, enveloped, RNA-containing retrovirus, EMuLV, which belongs to the same viral system group as HIV and has many characteristics similar to HIV. 1 · Anti-Ecotropic Murine Leukemia Virus Assay This assay consists of two parts, a cytotoxicity test and a virus suppression test. See QBI Project Book 39014 Final Report and QBI Project Book 39016 Final Report, Quality Biotech, Camden, NJ, USA, 1992, each sample was initially tested for cytotoxicity to SC-1 indicator cells, which are used for XC phagocytosis Titration of infectious EmuLV in plaque assays. The cytotoxicity reported herein is expressed as a percentage of proliferation in the control group. Higher percentages indicate that the substance tested is non-toxic to cells. This is important because highly toxic compounds will explain the results of scew measurements. For example, high activity and high cytotoxicity (low% of control group proliferation) in the HIV assay means that the test compound inhibits the growth of host cells and thus limits the growth of the virus. Therefore, false positives of antiviral activity can be explained. See QBI Project Book C30015, Quality Biotech, Camden, NJ, USA. Each sample was dispersed in a virus-free virus resuspension buffer (50 mM Tris, pH 7.8, 10 mM KCL, 0.1 mM EDTA). Then make the solution at 50- This paper size applies Chinese National Standard (CNS) A4g (210X297mm) Please read the note on the back of Λ first

Page Printed by the Consumer Standards Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs 1232104 V. Description of the Invention (48) Accept the xc plaque assay under the same conditions as the EM11LV titer. If the indicated cells for the assay are less than 50% confluent culture, the sample is considered to be cell mother. Select non-cytotoxic sample concentrations for virus suppression tests. In the virus suppression test, each sample was mixed with EmuLV (AKV623 strain, potency 2. 2_4.2 X 105 PFU / ml) in virus resuspension buffer at 23-25 mg / ml (eg 100 mg / 4.0 ml) ) Cultivate 12-32 points. Adjust the pH of the maggot-treated virus suspension, if necessary, to within 6 · 8-7 · 2: test its titer in the X C plaque assay. Dilute a portion (1.5 ml) in the cell culture medium to the end points 0.00, 10 · 1, ΗΤ2, 10 · 3, 10-4, 10-5, 10-6, 10-7, and 1 0.8 dilution, or as appropriate). Each dilution was vortexed, any pellets were resuspended (if present), and the X C plaque assay was repeated twice for infectious virus particles. The positive control group (untreated virus suspension) and negative control group (cell culture medium, virus-free) were also analyzed to confirm this analysis. The anti-EMuLV activity of the sample is expressed as loglG of the decrease in the titer of EmuLV when compared with the positive control group. A titer of 10 giG greater than 0.05 is considered active. Printed by the Consumer Cooperative of the Central Bureau of Standards of the Ministry of Economic Affairs. Initially tested HHT888-4 and HHT888-5 " as is, tested, and showed good antiviral activity at 25 g / ml and cultured with virus for 12 minutes at room temperature. (The loglG of the decrease in virus titer is 1 ^ to ^). Then they were tested for longer incubation time (32 points) with the virus at the same concentration. Each sample was also tested for soluble and insoluble portions in the virus resuspension buffer described above to see if any active components were water-soluble. Centrifuge at 10,000 × g for 10 minutes at room temperature to separate the soluble and insoluble fractions. Divide the soluble fraction ___ -51-\ The paper size applies the Zhongguanjia standard (〇 奶) 八 视 ^ (21 (^ 297mm) ~~ " '' 1.02 (90%) 1 1.04 (91%) 2 1.74 (98%) 2 1.59 (97%) 2 2.64 (99.8%) 2 1.35 (96%) 1 2.10 (99.2%) 2 2.05 (99.1%) 2 1.71 (98.1%) 2 1.72 (98.1%) 2 Economy Printed by the Consumer Standards Cooperative of the Ministry of Standards of the People's Republic of China 1232104 Α7 __Β7 V. Description of the Invention (49) is divided into two parts, one with a size of 0.45 micrometers, and the other without a size of "." Have any effect on the activity. Table 2 summarizes the results of the anti-EMuLV activity test. This result confirms that HHT888-4 and HHT888-5 and their soluble and insoluble parts have anti-EMuLV activity. When cultured for 32 minutes in milliliters, 10 g10 that caused a decrease in virus titer was 1.0 to 2.6. Microfiltration did not significantly affect the activity of any soluble fraction. Table 2 Anti-Ecotropic Murine Leukemia Virus Activity Cytotoxicity 3 Anti-EMuLV Active sample processing 25 2.5 0.25 mg / ml Reduced Log104 HHT888-4 "as is" with or without "as is" with or without solubility ... Solubility, after Concerns ... Insolubility — — HHT888-5 " As is " Is there any "as is" Is there dissolubility ... Fallability 'pass; Concerns---- Insoluble i Health — ~ —

1 -52 2 This paper size is in accordance with Chinese National Standard (CNS) A4 (210X297 mm). 3 If the SC-1 indicates that less than 50% of the cells are confluent culture, the sample is considered cytotoxic. 4 When compared with a working virus suspension with a potency of 2.2-4.2 X 105 PFU / ml (plaque-forming units / ml) or Log10 (PFU / ml) = 5.34-5.62. The brackets in parentheses indicate the percentage reduction in virus titer from the working virus suspension. 1232104 A7 B7 V. Description of the invention (50) *** The culture time is 12 minutes, and the content is tested at 25 mg / ml. Activity can be caused by the sample 'or by microbial contamination, or non-specific physical interactions between the sample particles and the virus, because the sample is not sterilized and filtered before the measurement. **** Incubation time: 32 minutes. For "unfractionated samples of π", the test content is 25 mg / ml. For soluble, soluble and sterilized filters, and insoluble fraction, the test content is equivalent to 2 Unfractionated sample at 3 mg / ml. The data contained in Table 2 proves that TT888-4 and TT888-5 are effective anti-EMuLV agents. 2. Anti-human immunodeficiency virus assay This assay also contains two parts, Toxicity test and HIV inhibition test. Mix the sample in cell culture medium, such as 50 mg in 1.00 ml. The mixture, vortex &centrifuge; separate the soluble and insoluble parts. The supernatant is filtered through a 0.45 micron filter membrane The cell culture medium was diluted to an appropriate concentration for determination. The cell culture medium used for this assay was RPMI 1640 supplemented with 10% fetal calf serum, 2 mM glutamine, 50 units / ml penicillin, and 50 μg / ml streptomycin. (pH 7 · 3 ± 0 · 3). This sample was used to determine the cytotoxicity and / or cytostatic activity of the target cells and human peripheral hemolymphs (PBLs). The lymphocyte proliferation assay was used for the toxicity test. Liter sample with 100 Microliters of cell suspensions of uninfected PBLs (3 X 105 cells) are cultured under conditions such as HIV suppression tests. Lymphocyte proliferation is measured by colorimetric assay (MTT-test). See T. Mosmann, J. Immunological Methods, 65., 55-63 (1983) 0 The concentration of 70% of the samples in the control group was considered to inhibit HIV-53. This paper is in accordance with Chinese National Standard (CNS) A4 (210X297 mm). ) Please read the notes on the back first

Page Printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs 1232104 A7 B7 V. Description of Invention (51) The test is acceptable. Printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs. In the HIV suppression test, PBLs infected with HIV-1 were cultured for 4 days in the presence of samples as in the toxicity test. See H. Ruebsamen-Waigmann et al., J. Med. Virology, 1 £, 335-344 (1986). ELIS A technology and HIV-RNA blot hybridization technology were collected by HIV-1 p24 on the 3rd and 4th days, respectively, and the secreted viral core protein p24 and / or viral RNA were used as indicators of viral proliferation status. The concentration of p24 synthesized by HIV-infected cells was determined by Sandwich ELISA. A standard preparation of recombinant p24 (MicroGeneSys, USA) was used for ELISA calibration. See Ch. Mueller et al., Fresenius Z. Anal. Chem., 330. 352-353 (1988) ° HIV-RNA synthesized in infected cells was determined by nucleic acid hybridization technology. RN A of cells was prepared from infected cells and Analysis by ink dot hybridization technique. The hybrid solution contains a P32-labeled DNA probe, which contains a 5.5 DNA fragment of HIV isolate D31, see Η V. Briesen et al., J. Med. Virology, 21, 51-66 (1987). This fragment covering the gag / pol region of the virus was labeled with oligonucleotide and P32 with -d CTP. The gag / poi region from virus isolate D31 corrected strand RNA transcripts was used as an extra standard for hybridization. These ·· outflows ·· transcripts are produced by a T 7 polymerase reaction under the control of a negatively-activated HIV-DNA under the control of a T7-activator gene. The concentration of the RN A transcript was determined by spectroscopic spectrometry. The hybridized probe is detected by automatic radiogram method, and the processed automatic radiograph is evaluated by density meter. The positive control group, the negative control group and the AZT control group were performed simultaneously to evaluate the effectiveness of the HIV suppression test. All tests were performed in triplicate, 96-well round bottom microtiter plates were used for all determinations. _ -54- This paper size applies Chinese National Standard (CNS) M specification (2 丨 0X297 mm) 1232104 A7 B7 V. Description of the invention (52 Positive control group is HIV cultured in the presence of cell culture medium without samples -1 Infected lymphocytes. The negative control group was lymphocytes infected with inactivated virus inoculum that could not be replicated with heat. These "infected" lymphocytes were cultured in the same way as infected cells and Assay. The amount of viral protein present in the culture is determined as the background because of the remaining inoculum. Then the p24 content minus the background content is determined by the test sample and the positive control group due to virus replication. Viral protein P24 will compare the amount of viral protein present in the sample-containing culture due to virus proliferation to those in the positive control group, i.e., those in the culture without the sample. The difference in content is divided by the p24 content of the positive control group and then multiplied by 100% to determine the% inhibition of HIV proliferation. As the azide thorium (AZT) is 100, 10, 1 and 0.1 ng / ml, respectively Lymphocyte-infected HIV-1 cultured in the presence of concentrations was used as the AZT control group. This provides an assessment of the sensitivity of lymphocytes to AZT, which is known to be an inhibitor of HIV-1 replication. The inhibitory effect of HIV-1 proliferation should be higher than 50% when compared with the untreated positive control group. Table 3 summarizes the cytotoxicity and HIV suppression tests of HHT888-4 and HHT888-5 and AZT control groups. Result. The two herbal mixtures were active at 2.5-5.0 mg / ml in infected human lymphocytes to inhibit the proliferation of HIV, but were inactive at 50 μg / ml (50-100 times dilution). The AZT control group showed the expected activity and thus ensured the validity of this test. 55- This paper size is applicable to the Chinese National Standard (CNS) A4 specification (210X297 mm) Please read the %% matter first_ Consumption by Staff of the Central Bureau of Standards Printed by the cooperative 1232104 Α7 Β7 Printed by the Consumers' Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs 5. Description of invention (53 Table 3 Anti-HIV activity test of ΗΗΤ888-4 and ΗΗ8888-5 HTV inhibition ~~ m ~

RNA sample concentration Cytotoxicity * Day 3 Day 4 Day 3 Day 4 HHT888-4 2.5 mg / ml &gt; 46% 100% 100% 100% 100% 50 μg / ml 85% 1% 6% __ one HHT888 -5 5.0 mg / ml 75% 100% 97% 99% 100% 50 μg / ml 86% 0% 12% 1 · AZT 100 ng / ml 99- 100% 100% — 10 ng / ml • 85 -98% 77-96% 1 ng / ml — 20-39% 8-12% 0.1 ng / ml 0% 0-3% * Proliferation percentage of control group. HHT888-4 is 46% at 5.0 mg / ml. Both HHT888-4 and HHT888-5 were cytotoxic at 25 mg / ml (<50% of the control group). HHT888_4 and HHT888_5 at 2.5_5.0 mg / ml, HIV proliferation in infected human lymphocytes was substantially completely inhibited: determined on the 3rd and 4th day after treatment, based on the viral protein ρ24 of 97-100% and Virus-based & \ eight is 99-100% inhibition. The anti_1 ^ 1 \ ^ activity at 50 µg / ml is negligible 'and has a 0-12% inhibitory effect on the two herb mixtures. The activity could not be attributed to insoluble pellets, as they were filtered out with a 0.45 micron membrane before the assay, and the activity was not attributed to cytotoxicity. Repeated tests on 3 batches of ΗΗ888-4 showed that with acceptable cytotoxicity (control group proliferation of 71-100%), there was 100% inhibition at 2.5 mg / ml on days 3 and 4. For 3 batches (2.5 亳 -56- this paper size applies to China National Standard (CNS) 8 4 specifications (210 × 297 mm) C, please read the precautions on the back page first} — — Binding and ordering 1232104 Ministry of Economic Affairs Printed by A7 B7 of the Consumer Standards Cooperative of the Central Bureau of Standards 5. Repeated experimentation of the invention description (54) g / ml of HHT888-5 showed that acceptable cytotoxicity (control group 85-91% proliferation) on day 3 There are 93-98% and 89-99% inhibition on the 4th day. The results of repeated experiments are shown in Table 4. Table 4 Anti-HIV activity of HHT888-4 and HHT888-5 and their water extracts HIV inhibitory effect ** Sample batch weight% Test concentration Cytotoxicity 1 2 3 Day 3 Day 4 ΗΗ888-4 1 100% 2.5 mg / ml &gt; 46% 100% 100% 2.5 mg / ml 98% 100% 100% 0.05 mg / ml 85% 1% 6% 2 100% 2.5 mg / ml 100% 100% 100% 100% 2.5 mg / ml 71-79% 100% 100% 888888-4-Ε1 2 17% 1.0 mg / ml 98% 100% 96 % Ε2 2 11% 1.0 mg / ml 96% 100% 87% Ε 2 28% 1.0 mg / ml 47% 100% 100% 0.5 mg / ml 78% 100% 100% 4 27 ± 1% (+) 1.0 mg / Ml 72 % 100% 100% 1.0 mg / ml 100% 100% 93% 0.1 mg / ml 97% 34% 12% 0.02 mg / ml 82% 23% 2% 888888-5 1 100% 5.0 mg / ml 75% 100% 97 % 2.5 mg / ml 89% 93% 91% 0.05 mg / ml 86% 0% 12% 2 100% 2.5 mg / ¾: 91% 94% 89% 100% 2.5 mg / ml 44-85% 98% 99% 0.5 mg / ml 52-100% 0% 0% ΗΗΤ888-5-Ε 2 19% 1.0 mg / ml 91% 71% 26% Batch-(Please read the precautions on the back first \ | ^ 舄 本本) 、 tr 1 Toxicity is expressed as a percentage of the proliferation of the control group. 2 HIV inhibition based on the content of viral protein P24. 3 Each single herbal component is an equal composition. No. 5 (10) and Ed. Applicable to China National Standard (CNS) A4 specification (210 × 297 mm) 1232104 A7 B7 Printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economy in. + Based on 2 determinations. It should be noted that the third batch of HHT888-4 or HHT888-5 was prepared by mixing equal parts by weight of each single herb component. The third batch of HHT888-5 consists of 9 single herb components, with the exception of numbers 5 (10) and 5 (11). Water extracts (E to E2) of HHT888-4 and HHT888-5 from batches 1 to 2 were retested to see if the active components were water-extractable. Preparation of water extracts of HHT888-4 and 5 was performed by extracting 5 g of powder with 25 ml of MilliQ purified water (twice). Each aqueous suspension was vortexed for 1 minute, left for 5 minutes, and vortexed again for 1 minute to facilitate extraction. Centrifuge at 1,000-2,000 rpm for 20 minutes to separate the extract and insoluble matter. The supernatant was transferred to a clean, pre-weighed 50 ml centrifuge tube, freeze-dried, weighed and tested for anti-HIV activity. The weight percentage of the extract material for the first 25 ml of HHT888-4 (batch 2) extract was 17.3%, and the weight percentage of the extract material for the second 25 ml extract was 10.8%. For the first 25 ml of HHT888-5 (batch 2), the extract was 14.2%, and for the second 25 ml of the extract was 4.6%. The first (E1), second (E2) and combined (E) extracts of HHT888-4 (batch 2) were tested for anti-HIV activity. All other extracts were tested by combining the first and second extracts. The results are also described in Table 4. All three batches of each herb mixture were very active, with 100 ° / 0 inhibition at 2.5 mg / ml for HHT888-4 and 89-100% inhibition at 11-11 888-5 at 2.5-5.0 mg / ml. For 1111 Ding 888-4 1 (: 50 is between 0.05-2.5 mg / ml, and for HHT888-5 is 0.5-2.5 mg / ml _-58- This paper size applies Chinese National Standard (CNS) A4 Specifications (210X297 mm) (Please read the precautions on the back before this page)

Order spring-1232104 A7 B7 V. Description of the invention (56). IC5. The concentration of the test substance that will cause 50% inhibition of virus proliferation. The water extract of HHT888-4 shows very good activity: at 0.5-1 · 0 mg / ml, 93-100% inhibition. The first batch (E1) and the second aqueous extract (E2) of the second batch showed comparable activity: 100 mg inhibition at 1.0 mg / ml on the third day and 87-96% inhibition on the fourth day. The IC50 of the water extract of HHT888-4 is between 0.1-0.5 mg / ml. The water extract of HHT888 · 5 (batch 2) showed substantially lower activity: 1.0 mg / ml on day 3 with 71% inhibition, which decreased to 26% on day 4. The main active ingredient is clearly left in the insoluble part, and unlike HHT888-4, it cannot be easily extracted with water under the aforementioned conditions. It should be noted that the water extract of HHT888-5 (batch 2) constitutes 19% by weight of the herb mixture. The test concentration of 1.0 mg / ml of the water extract of HHT888_5 (or HHT888-5-E) is equivalent to 5.3 mg / ml of HHT888-5 itself. HHT888-5 was tested at 2.5 mg / ml (93_98% inhibition on day 3 and 89-99% on day 4) and 5.0 mg / ml (100% inhibition on day 3 and 97% on day 4). With great activity. The above results clearly demonstrate that HHT888-4 and HHT888-5 and their water extracts have anti-retroviral activity in vitro, and more specifically, anti-EMuLV and anti-HIV activity. HHT888-5 has also been shown to be effective in treating hepatitis B virus carriers. Example 5 Anti-retroviral test of individual single-herb herbs In this experiment, individual single-herb components of HHT888-4 and HHT888-5 were tested for anti-HIV activity. Table 5 presents the test results. 59 This paper size is in accordance with Chinese National Standard (CNS) A4 (210X297mm). Please read the notes on the back first.

Printed by the Consumers' Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs 1232104 A7 ___B7 V. Description of the invention (57) Table 5 Anti-HIV activity HIV inhibitory effect of the single herb component of HHT888-4 and HHT888-5 ** Sample batch test concentration cell Toxicity 1 2 Day 3 Day 4 No. 4 (1) 3 1 2.5 mg / ml 98% 73% 50% No. 4⑵ 1 2.5 mg / ml 74-84% 92% 94% No. 4 (3) 1 2.5 mg / 75-78% 100% 100% No. 4 (4) 1 2.5 mg / ml 74-100% 100% 100% No. 4 (5) 1 2.5 mg / ml 41-79% 98% 92% 0.5 mg / ml 47 -100% 0% 0% No. 5 (1) 3 1 2.5 mg / ml 98% 73% 50% No. 5 (2) 1 2.5 mg / ml 73-87% 18% 29% No. 5 (3) 1 2.5 mg 89-100% 0% 0% No. 5 (4) 1 2.5 mg / ml 64% 100% 100% 1.0 mg / ml 69-91% 0% 0% No. 5 (5) 1 2.5 mg / ml 80- 84% 93% 93% No. 5 (6) 1 2.5 mg / ml 94-100% 0% 0% No. 5 (7) 1 2.5 mg / ml 90-100% 50% 38% No. 5 (8) 1 2.5 mg 32-59% 100% 100% 0.5 mg / ml 65-100% 0% 0% No. 5 (9) 1 0.5 mg / ml 24-78% 0% 0% No. 5 (10) 1 2.5 Mg / ml 100% 65% 0% No. 5 (11) 1 2.5 mg / ml 100% 92% 74% Printed by the Consumer Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs

1 Toxicity is expressed as a percentage of control group proliferation. 2 HIV inhibition based on the content of viral protein p24. 3 No. 4 (1) = No. 5 (1) All 5 single herb components of HHT888-4 show various levels of anti-HIV activity ... at 2.5 mg / ml, 73-100% inhibition on day 3 and at 50-100% inhibition on day 4. Nos. 4 (3) and 4 (4) show the best activity: 100% inhibition at 2.5 mg / ml on the 3rd and 4th days. No. 4 (2) and No. -60- This paper size applies to China National Standard (CNS) A4 specification (21 ×: 297 mm) 1232104

Printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs 4 (5) followed by 2,5 mg / ml, 92.98% inhibition on the third day and 92-94% / 0 inhibition on the fourth day. Number 4 (1) showed moderate activity: at 25 mg / ml, 73% inhibition on the 3rd day, and 50% inhibition on the 4th day. Number 4 (5) shows microcytotoxicity (41.79% of control group proliferation), which may be a factor of the observed activity, between 0.5 and 2.5 mg / ml. 1 of HHTm_5! 3 of the single herb components: No. 5 (4), No. 4 (5) 'and No. 5 (8) show very good activity, with 25 mg / ml on day 3 and At 4 days, 93-100% inhibited HIV proliferation. No. 5 (11) was next, with 2.5 mg / ml 92% inhibition on day 3 and 74% inhibition on day 4. No. 5 (1) is the same as No. 4 (1) and has a moderate activity: 2.5 mg / ml '73% inhibition on the 3rd day and 50% inhibition on the 4th day. Nos. 5 (2) and 5 (7) show only minimal activity: 18-50% inhibition at 25 mg / ml on day 3 and 29-38% inhibition on day 4. No. 5 (10) showed very little activity: at 2.5 mg / ml, it was inhibited by 65% on the third day and decreased to 0% on the fourth day. The remaining 3 single herb components, No. 5 (3), No. 5 (6) and No. 5 (9), showed no activity at 0.5-2.5 mg / ml. No. 5 (9) was not tested at 2.5 mg / ml because of its toxicity: 0.5-mg / ml had 24--78% proliferation in the control group. Although No. 5 (4) and No. 5 (8) showed slightly more activity than No. 5 (5) (2.5 mg / ml, 100% vs. 93% inhibition), their activity may be partly attributed to the cells Toxicity (at 2.5 mg / ml, 32-64% of control group proliferation). This is supported by the loss of activity (0% inhibition) when tested at a lower level of 05-10 mg / ml, when the cytotoxicity is lower and more acceptable than the assay. -61-The paper size is in accordance with the Chinese National Standard (CNS) A4 specification (210X297 mm) (Please read the precautions on the back ^^ page). Binding · Order 1232104

Example 6 Anti-HTV Test of Star Plants &gt; The source plant of single herb herbal number 5 (5), wild i was obtained from a local Lecao store in Taiwan and tested for anti-HIV activity. This is to see if the activity can be reproduced in herbal medicines prepared directly from its source plants, instead of being obtained from commercial sources. The whole grass was washed with cold water, dried, pulverized and extracted with boiling water as described in Example 2. The aqueous solution was separated from the plant material by filtration. The volume of the aqueous solution was reduced by heating. The concentrate was spray-dried and absorbed on a powder material on the same plant material, so that a herbal medicine in powder form was prepared, and was hereinafter referred to as a raw material number 5 (5). Powder herbal medicine prepared from Noritake, or raw material No. 5 (5), extracted with water at ambient temperature, 2 5.00 g samples, each time in a separate 50 ml plastic centrifuge tube, each with about 40 ml of water Two times, vortex for 1 minute, put 10 minutes, and vortex for 1 minute. The centrifuge tube was centrifuged at 1,500 rpm for 20 minutes, and the extract was separated from the insoluble residue. The extract was filtered through Whatman No. 4 filter paper, lyophilized or dried under N2 and weighed. The above raw material number 5 (5) was repeated and extracted with water (pH ~ 5.1). The pH of the first extract was measured to be 5.7. Separate the first and second extracts from the residue, air dry and weigh. The weight percent of extractables was determined to be 18.7 to 2.8% (n = 2). The first water extract of raw material No. 5 (5) was tested for anti-HIV activity and found to be active at 1.0 mg / ml in 91% inhibition on day 3 and 97% inhibition on day 4. Cytotoxicity showed that the extract had no cytotoxicity at this level, which was 99% of the proliferation of the control group. -62- _ This paper size applies to Chinese National Standard (CNS) A4 (210X297 mm) (please read the note on this page first) • Packing. Printed by the Consumer Standards Cooperative of the Central Standards Bureau, Ministry of Economic Affairs, printed 1232104 A7 B7 V. Description of the invention (60 Example 7 Treatment of patients with hepatitis C HHT888-5 has proven to be effective and safe in the treatment of human HBV infection. That is, the active ingredients of HHT888-5 must be orally administered to humans as a living body. Utilization caused a reduction in HBV in those patients treated as indicated by a reduction in their HBV surface antigen (HBsAg) shown in Example 3. In addition, Hozumi et al. Provided examples in US Patent No. 5,411,733 Supports substances believed to exhibit antiviral activity in vitro, as well as antiviral activity in vivo, as described in the previous section. Therefore it is logical to believe that HHT888-4 or HHT888-5 and its water extracts or active ingredients are To treat HIV infection in humans, it should also be effective. To test this idea, six of the most active anti-HIV single herb components of HHT888-4 and HHT888-5 were selected to treat hepatitis C caused by HCV infection Patients. The logic is that both HCV and HIV are retroviruses. Hepatitis C virus is prone to become a chronic disease and is therefore more suitable for treatment. If treatment is effective for patients infected with HCV, it is also effective for patients infected with HIV. Experiment 7 This idea has clearly proved to be effective. Select 6 of the most active anti-HIV monoherb components of HHT888-4 and HHT888-5 to treat patients with hepatitis C infected with HCV. 6 monoherbs selected Herbs are numbered 4 (2), numbered 4 (3), numbered 4 (4), numbered 5 (4), numbered 5 (5), and numbered 5 (8). Although numbered 4 (5) shows good activity However, this herb is not included because it is known to have some undetermined toxicity. These 6 single-herb herbs are obtained from commercial sources and are manufactured in accordance with Good Manufacturing Practices 63- This paper is a Chinese standard (CNS) ) A4 size (210X297mm) Please read the notes on the back _ printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs 1232104 printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs A7 B7 5. Description of the invention (61) (GMP) Manufacturing. Make them according to the required proportion in various combinations Then, prepare the herb mixture HHT888-45 as described in Example 1. Obtain the patient's consent before starting treatment. Instruct the patient to take the herb mixture daily; 3 times, 2.7-5.7 g each time. The unit of this herb mixture HHT888-45 Dosages are prepared in individual packages. Each unit dose package (2.7-5.7 grams) of the herbal mixture is mixed with warm water for oral administration. All patients are included with the number 4 (3), number 4 (sentence, number 5 (4) and number 5 (5) HHT888-45 treatment. No. 5 (8) or No. 4 (2) or both are added to HHT888-45 to treat some patients at the beginning or during the treatment process to promote the effectiveness of the treatment. During the treatment, the doses of No. 4 (3), No. 4 (4), No. 5 (4), and No. 5 (5) changed from 2 to 3 grams. The dosage of No. 4 (2) changes from 1.5 to 2 grams when used. The dose varies depending on the progress of the disease. Treated 7 patients with hepatitis C virus. During the treatment period, liver enzymes, SGOT, and STPT in their serum were often measured by local clinical laboratories to monitor the progress of the disease. Determination of SGOT and SGPT using enzyme assays. See (1) Instructions for Kyokuto TA-E Transaminase Assay Reagent, License No. (62AM) 0885, Kyokuto Pharmaceutical Industry Co., Tokyo, Japan, 1994; (2) Yatrozyme TA-Lq Transaminase Assay Reagent Instructions for solution (enzyme measurement), Article No. 817245 (RM163-K), Yatron Corporation, Diayatron Corporation, Tokyo, Japan; and (3) U. Lippi &amp; G Guidi, Clin. Chem. Acta., 28, 431-437 (1970) 〇

The levels of serum GOT and GPT are closely related to the degree of damage to cells in the liver. These tests are widely used in the diagnosis of liver disease and as indicators of liver function. SGOT __ -64 -__ This paper size is applicable to Chinese National Standard (CNS) A4 (210X297mm) (Please read the precautions on the back of this tile first)-Packing. Order 1232104 A7 B7 V. The normality of the description of the invention (62) The range is 8-40 units / ml, while SGPT is 5-35 units / ml. Elevated SGOT and SGPT levels usually indicate compromised liver function. The HHT888-45 treatment results are shown in Table 6. In all the 7 patients treated, the serum liver enzymes rose from 17 to 178 days after treatment (SGOT from 48 to 166 units / ml and SGPT from 41 to 291 units / ml) and returned to the normal range (SGOT (From 8 to 40 units / ml and SGPT from 5 to 35 units / ml). Therefore, the patient's liver function returns to normal after taking the composition of the present invention. Table 6 Clinical effects of HHT888-45 * on patients with hepatitis C SGOT **, unit / ml SGPT **, unit / ml during treatment before treatment after treatment before treatment (number) (please read the precautions on the back) (This page) 2 1A 8 3 Printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs 48 3065162143833656752752201 5313443222222976454433332 23 03 79 11 7 6582176303549349185026557 4316665454542276544432653

479097305278896420098607 67 223578017 12345778578 1X 1x 1X This paper size applies to Chinese National Standard (CNS) A4 specification (210 X 297 mm) -65- 1232104 A7 B7 V. Description of the invention (63) SGOT **, unit / ml SGPT ** In units / ml during the period before and after the treatment before the treatment (days) 5 83 64 67 54 8 58 46 14 56 40 22 42 34 29 38 28 36 6 166 106 291 206 2 71 121 16 51 81 22 57 89 29 36 45 45 31 36 50 28 37 58 22 29 64 28 32 71 25 27 85 36 28 103 23 27 113 23 22 163 7 30 28 41 42 9 29 32 17 * Mainly contains the numbers 4 (3), 4 (4) , 5 (4) and 5 (5), and sometimes 4 (2) (please read the notes on the back first to write this page).

, 1T Printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs and 5 (8). ** SGOT = serum glutamine, chloramphenicol acetate transferase; normal range = 8-40 units / ml. SGPT = serum glutamine pyruvate transferase; normal range = 5-35 units / ml. The results clearly demonstrate that the herbal mixture HHT888-45 is effective in treating patients with hepatitis C. To accomplish this, the pathogenic HCV must be eradicated or reduced to a tolerable level. The HHT888-45 component has been shown to have strong anti-HIV activity in vitro, and several components have been shown to be effective in reducing the HBV of carriers, so the herbal mixture is effective in treating patients infected with HIV and HBV. -66- This paper size applies Chinese National Standard (CNS) A4g (210X297 mm) 1232104 A7 B7 V. Description of the invention (64) Therefore, one aspect of the present invention is to include the herb mixture according to the present invention and their various proportion And an effective dose of a single herb component of antiviral herbs is effective in treating hepatitis C, hepatitis B and other retroviral diseases such as AIDS. Since the clear chemical identification and pharmacological mechanism of the composition of the present invention has not been explained, the antiviral activity may be attributed to a single herb component, a mixture of components, or a biological metabolite or a derivative thereof. The following example studies the chemical identification of the active ingredients described in this application. Example 8: Fractions of the active mono-herb component The three most active anti-HIV mono-herb components of HHT888-5: No. 5 (4), No. 5 (5) and No. 5 (8) extracted with water, C18 solid phase Extraction (SPE), column liquid chromatography (C18-SEP-LC) and C18 column high performance liquid chromatography (C18-HPLC) fractions. The HHT888-4 fraction of the herb mixture was also compared for comparison. The purpose is to identify the active compounds of various anti-HIV active herbs or herbs. 1. Printed by the Consumers' Cooperative of the Central Standards Bureau of the Ministry of Water Extraction Economy (please read the precautionary page on the back). -4 Extract with water at ambient temperature (about 25 ° C), 8 to 10 ml of water per gram of sample each time (for example, 5 g of powder in 40 ml of water and 50 g of powder in 500 ml of water). Stir the water suspension for 15 minutes or vortex for 1 minute, let it stand for 10 minutes and vortex for 1 minute. The water extract was separated from the insoluble matter by centrifugation (1,500 rpm) for 20 minutes and filtered through Whatman No. 4 paper. -67- This paper size is in accordance with Chinese National Standard (CNS) A4 (210X297 mm) 1232104 A7 B7 V. Description of Invention (65)

2. Each water extract of CHSPE-LC was fractionated by Cl8-SPE column liquid chromatography. A 10 ml portion of the extract was loaded on a 10 g ISOLUTE C18 (EC) -SPE column (available from International Sorbent Technology, Hengoed, Mid-Glamorgan, UK or Jones chromatography, Lakewood, Colorado, USA), which Equilibrate with 50 ml of ethanol and 100 ml of water beforehand. SPE column (2.6 cm inner diameter x 2 · 7 cm long, plus 60 ml storage tube) with 10 g end-capped (EC) C18 sorbent particles: average particle size is 61 μm and 19% Carbon filler filling. The packed column was dissolved by gravity with 90 ml of water, 100 ml of ethanol, 100 ml of 1% HC1 (in ethanol) and 50 ml of 0.1% HC1 (in ethanol / water at 10/90 v / v). The eluate was collected in a 50 ml sample. The water eluent is freeze-dried in a glass bottle or air-dried in a plastic weigher. Ethanol, acidic ethanol and acidic ethanol / water dissolve were air-dried in plastic weighing orphans. Air-dried acidic ethanol (1% HC1 (in ethanol)) and acidic ethanol / water (0.1% HC1 (10/90, v / v) in ethanol / water) were dissolved in 1% HC1 / ethanol. And water, transferred to a 4 ml WISP vial, and dried under Qin. Dry part (A) of the first 50 ml water eluate, first 50 ml of ethanol eluate (B), first 50 ml of 1% HC1 / ethanol eluate (C) and 50 ml of 0.1% HC1 / 10% ethanol / 90% water eluate (D) was tested for anti-HIV activity as previously described. The results are shown in Table 7. -68- The size of this paper is applicable to China @ ^ ((: 阳) 8 4 specifications (210/297 mm) (please read the precautions on the back v * installation-buy the product) Printed by the Consumer Cooperative 1232104 A7 B7 V. Description of Invention (66) Table 7 C18- SPE-LC Grade Part of HHT888-4E, No. 5 (4) E, No. 5 (5) E and No. 5 (8) E Anti-HIV activity C18-SEP-LC Anti-HIV activity * Water extract fraction fraction **% by weight *** Test content toxicity **** Day 3 Day 4

HHT888-4E

Α Β c D 70.0 soil 4.5% 0.7¾ g / liter-50-73% 18.5 soil 1.3% 0.2 mg / bucket 21-95% 6.7 soil 2.7% 0.1 mg / bucket 98% 2.1 ± 1.5% 0.1 mg 100% %%%% 8 0 5 2 9 0 9 4 1 %%%% 17 5 0 6 8 8 No. 5 (4) EA 78.6 ± 7.6% 1.0 mg / 亳 0.2 mg / ml Β 14.6 ± 3.9% 0.1 mg / ml 0.05 mg / ml C 4.1 ± 0.3% 0.1 ¾ g / ¾ liter D 3.0 1.5% 0.1 mg / 亳 liter%%%%% 8 7 8 8 16 7 9 6 6 9 9 6- &gt; / ¾ / ¾ Λ ^ / Λ ^ / 9 0 0 3 9 9 9 9 8 6 4 1 / ¾ Λ ^ / 4 0 2 0 0 0 1 2 (Please read the precautions on the back page first) • No. 5 (5) EA 73 · 9 ± 7.9% 1.0 mg / L 98% 0.3 mg / L 97-98% 0.3 mg / L 4 85-90% 0.1 mg / L 85% %%%% 0 0 9 1 0 0 9 9 %%%% 0 4 9 6 0 9 9 8 1TB B 14.6 soil 4.1% 0.1 mg / ml 0.07 mg / liter C 8.6 soil 1.8% 0.1¾ g / halo D 2.5 soil 1.7% 0.1 mg / liter %%%%% 0 16 0 9 4 9 %%%% 8 9 6 5 9 9 9 2 %%%% 8 8 9 6 4 4 9 9 System number 5 (8) EA 43 6 soil 2.6% 0.5 mg / ml 0.3 mg / ml 70% 70- 100% Β 53.7 clay 5.0% 0.3 mg / mL 0.1 mg / mL and 24-68% 68% C 2.2 ± 0.9% 0.1 mg / mL 100% D 1.6 clay 0.5% 0.1 mg / mL and 95% 3 6 0 8 9 4 9 9 0 8 4 1 / ¾ 4 5 0 0 0 0 5 0 3 * Inhibition of HI V proliferation based on the content of viral protein p24 〇 / 0 ** A = water eluate; B = ethanol eluate; C = 1% HC1 / ethanol eluate; D = 0.1% HCl / 10% ethanol / 90% water eluate. -69- This paper size is in accordance with Chinese national standard (milk milk) 8 4 specifications (21〇 '/ 297 public attack) 1232104 A7 B7 V. Description of the invention (67) * * * Determined from 3 to 5 measurements. **** Toxicity is expressed as a percentage of control group proliferation. Table 7 sets forth the results of the cytotoxicity and anti-HIV activity tests for HHT888-4E, No. 5 (4) E, No. 5 (5) E, and No. 5 (8) E of the C18_SPE_LC fractions A, B, C, and D. The average weight% and standard deviation (determined from 3 to 5 chromatographic determinations) of each C18-SPE-LC fraction fraction of the water extract (E) of each sample are also shown in Table 7. Sample loading per column for each chromatography, 199 to 205 mg for HHT888-4E, 94 to 95 mg for number 5 (4) E, and 124 to 130 for number 5 (5) E Mg, and 165 to 178 mg for number 5 (8) E, based on dry weight. Printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs, the water dissolving liquid (A) and 1% HC1 / ethanol dissolving liquid (C) and the 1% HC1 / ethanol dissolving liquid of HHT888-4E are displayed. (C) Most active (with 0.1 mg / ml, 91 to 96% inhibition of HIV proliferation on day 3 and 85 to 96% inhibition on day 4) and no cytotoxicity (85 to 99 in control group) %). Air drying does not affect the activity of the water-dissolved part (A) of No. 5 (5) E. Air-dried No. 5 (5) EA showed an activity of 99% inhibition at 0.3 mg / ml on day 3 and day 4, and 91% inhibition at 0.1 mg / ml on day 3 and 86% inhibition on day 4. active. For comparison, cold beam dried No. 5 (5) EA showed 100% inhibition at 1.0 mg / ml on days 3 and 4 and 100% inhibition at 0.3 mg / ml on day 3 and 94% on day 4. Inhibitory activity. HHT888-4E No. 5 (5) E and No. 5 (8) E in ethanol eluate (B) also show good anti-HIV activity: For HHT888-4E, 0.2 mg / _-70- This paper size applies Chinese National Standard (CNS) A4 specification (210X297 mm) 1232104 Α7 Β7 Printed by the Consumers' Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs 5. Description of invention (68) ml was 100% inhibited on the third day and 87% inhibited on the fourth day, For No. 5 (5) E, 0.1 mg / ml inhibited 98% on Day 3 and 90% on Day 4 and for 5 (8) E, 0.3 mg / ml inhibited on Day 3 and 4 All days are 100% inhibited. However, the observed activity can be attributed in part to cytotoxicity: 21 to 95% of control group proliferation for HHT888-4, 48% for number 5 (5) E, and 68% for number 5 (8) E. This hypothesis is supported by a significant reduction in activity when the sample concentration is reduced to a less cytotoxic level. For example, for No. 5 (5) E-B, when its concentration was reduced from 0.1 to 0.07 mg / ml, the activity was reduced from 90% to 41% inhibition on the fourth day. For No. 5 (8) E-B, when its concentration was reduced from 0.3 to 0.1 mg / ml, the activity was reduced from 100% to 30% inhibition on the 4th day. HHT888-4E and the water-soluble fraction (A) of No. 5 (8) E showed moderate anti-HIV activity; for HHT888-4E, it was inhibited by 0.7 mg / ml on day 3 by 98% and by day 4 by 61% Inhibition, and for No. 5 (8) E, 93% inhibition on day 3 and 54% inhibition on day 4 at 0.5 mg / ml. However, the activity can be attributed in part to cytotoxicity, which is 50 to 73% for HHT888-4E and 70% for number 5 (8) E. No. 5 (8) E_A When the concentration was reduced from 0.5 to 0.3 mg / ml (the degree of cytotoxicity at this time (70-100% of the control group is more acceptable)), the activity on the 4th day was changed from 54 % To 5%. The water-dissolved fraction (A) of No. 5 (4) E has minimal activity: 0.2 to 1.0 mg / ml, 90 to 99% inhibition on the 3rd day, and 14 to 20% inhibition on the 4th day. No. 5 (4) E ethanol eluate fraction (B) and No. 5 (4) E and 5 (8) E 1% HC1 / ethanol eluate fraction (C) and 0.1% HC1 / 10 of all 4 samples % Ethanol / 90% water-soluble chaotropic part (D), in test -71-(Please read the precautions on the back first

(This page) The size of the paper used in this edition is in accordance with the Chinese National Standard (CNS) A4 (210X297 mm) 1232104 A7 B7 V. Description of the invention (69) ^ — The content is essentially inactive: 0.05 to 〇! G / ml 14 to 80% inhibition on day 3 and 0 to 2% inhibition on day 4. The Cl8-SPE-LC fraction of No. 5 (5) E was subjected to additional chromatography to produce more No. 5 (5) E-A and C sections for evaluation. Load the water extract (E) No. 5 (5) directly (10 ml per column), or freeze dry or air dry, then drop it in water (20 to 80 mg / ml) and load (per column 5 ml) for the fractions. The total weight% distribution of each part of these chromatograms from number 5 (5) E is: A = 74.2 ± 6.0%, B = 12 · 2 ± 4.0%, C = 8.2 ± 2.1%, and D = 2.1 ± 0.9%. These are very consistent with those shown in Table 7.

3. C18-HPLC The above air-dried No. 5 (5) E-A was fractionated with C18-HPLC. A 500.9 mg sample was dissolved in 5.00 ml of water, which was then centrifuged at 1,500,111 for 20 minutes to separate the solution from the insoluble matter. The supernatant was filtered through a 0.45 micron filter to remove any insoluble residues and was named the water-soluble fraction (WS). The precipitate was pumped three more times with 5.00 ml of water and dried with N2 as the water-insoluble portion (WI). The water-soluble fraction (WS) was prepared by gradient HPLC using a column of Rainin Dynamax C18 (21 · 4 X 250 mm, 5 micron particles) and the following conditional fractions; Flow rate: 9.00 ml / min. system

Injection volume: 200 μl Detection: UV 214 nm, 2.00 AUFS gradient: time acetonitrile / water 0-10 minutes 10-25 minutes 25-30 minutes 3 0-3 5 minutes 35-70 minutes' pack-(please first Read the note on the back page) — 219% 2/98 98/2 (linear) 98/2 98/2 — 2/98 (linear) 2/98 -72- The paper size applies to the Chinese National Standard (CNS) A4 Specifications (210X297 mm) 1232104 A7 B7 V. Description of the invention (70) Collect fractions at 2.5 minute intervals. A total of 28 parts were collected at 22 5 ml for each part. Table 8 indicates that before performing this measurement, certain parts are collected. 0 Each of the above A-dried C18_HPLC fractions is equivalent to the starting material, that is, air-dried water-soluble fraction (ws) i 03 of EA No. 5 Anti-HIV activity was tested at a concentration of mg / ml. The purpose was to identify the active part of Jingfeng No. 5 (5) E-A, which was tested to be very active: 99% inhibition of HIV proliferation at 03 mg / ml (see Table 7). Any active fraction is expected to have a good 99% inhibitory activity at a concentration of the starting material t equivalent to 033 mg / liter. The air-dried No. 5 (5) E-a water extract (WS) and Shendian (WI) were also tested at 0.33 mg / ml. Table 8 presents the results. Contains weight percent of each part and part 3 contains the main peak. (Please read the precautions on the back first, and then install it in your ears. -Order-Printed by the Consumers' Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs -73 This paper size applies to China National Standard (CNS) A4 (210X297 mm)-/ ¾ / ¾ / ¾ / Ό / ¾ / Ό η ^ / Λ ^ / 006341000000110030 Printed by the Consumer Cooperatives of the Central Bureau of Standards of the Ministry of Economic Affairs 1232104 A7 B7 V. Description of the invention (71) Table 8 Air-dried No. 5 (5) Anti-HIV activity Anti-HIV activity of the HPLC portion of the insoluble portion and the water-soluble portion **** No. 5 (5) EA portion 1% by weight 2 Toxicity 3 4 Day 3 Day 4 Water insoluble (WI) 10.3% 100% 100% water-soluble (WS) 86.0% 100% 86% WS-HPLC-F1 & 2 6.8% 86% 0% WS-HPLC-F3 109% 73% 0% WS-HPLC-F4 2.7% 93% 8% WS -HPLC-F5 2.0% 100% 0% WS-HPLC-F6 0.7% 100% 15% WS-HPLC-F7 &lt; 0.2% 100% 46% WS-HPLC-F8 3.0% 100% 0% WS-HPLC-F9 &lt; 0.2% 100% 0% WS-HPLC-F10 &lt; 0.2% 87% 0% WS-HPLC-F11 &amp; 12 0.7% 91% 1% WS-HPLC-F13 &amp; 14 10% 96% 0% WS -HPLC-F15 &amp; 16 7.0% 89% 18% WS-HPLC-F17 &amp; 18 1.5% 77% 25% WS-HPLC-F19 &amp; 28 1.2% 80% 0%

1 WI and WS are air-dried water-insoluble and water-soluble parts of No. 5 (5) E-A. WS-HPLC-F1 to 28 are the HPLC part of WS. 2% by weight (ws) of starting material. 3 Toxicity, expressed as% proliferation of control group. 4 Activity, expressed as% inhibition of HIV proliferation based on viral protein p24 content. Test contents for air-dried WI and WS No. 5 (5) E-A (both 0.33 mg / ml). The test content for all HPLC fractions of WS was equivalent to 0.33 mg / ml of starting material WS. -74- This paper size is in accordance with Chinese National Standard (CNS) A4 (210 father 297 mm) Printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs 1232104 Α7 Β7 V. Description of the Invention (72) This part contains most of the substance, however, it is essentially inactive in anti-HIV assays. These results are amazing. All c18_Hplc fractions tested were essentially inactive, with 0-46% inhibition on day 3 and 0-4% inhibition on day 4. Hydrochloric county (WS) also showed significantly lower activity than expected (at 0.33 mg / liter, 86% inhibition on day 3 and 63% inhibition on day 4). Among the active components isolated and purified from medicinal plants, this type of inactivation has been widely experienced by others, mostly due to the loss of synergy when isolating compounds from the matrix of the compounds. Our results indicate that the active ingredient is surprisingly left in the water-insoluble portion (WI) 'instead of the water-soluble portion (ws) that was originally expected. The insoluble portion tested was very active and inhibited at 0.33 mg / ml on day 3 and on day 4. This means that the main active ingredient of air-dried No. 5 (5) E-A is in the water-insoluble component (WI), instead of the soluble portion (WS). The active ingredient numbered 5 (5) E-Α was originally soluble in water because it was soluble in the c 18_ SPE-LC water eluent. In air-drying, it must become water-insoluble and therefore remain in the water-insoluble part. The water-insoluble fraction must then have become soluble in the neutral cell culture medium as it is to be tested as active. This must be the case when the sample solution in the cell culture medium is centrifuged and the insoluble material is removed by filtration at 0.45 microns before the anti-HIV assay. Example 9 Identification of Active Components

1 · No. 5 (5) E-A The ρ η of the cell culture medium used to dissolve the samples for anti-HIV measurement is ____- 75- This paper size applies the Chinese National Standard (CNS) Α4 specification (210 × 297):

1232104 A7 B7 V. Description of the invention (73 Printed by the Consumer Cooperative of the Central Bureau of Standards, Ministry of Economic Affairs, 7.3 soil 0.3. Therefore, it is assumed that the active component of No. 5 (5) EA is soluble in neutral aqueous solution, such as cell culture medium, but changes Acidified and therefore insoluble when exposed to the atmosphere containing JJC1 when the gas cabinet is air-dried with other HC1-containing C18-SPE-LC parts. That is, the acid form of the active component numbered 5 (5) EA when acidified It is insoluble in water and precipitates. No. 5 (5) EA is the C18-SPE-LC water-soluble eluate portion of No. 5 (5) water extract. To test this hypothesis, we tested from No. 5 (5) EA The solubility of the above active precipitation (WI) in various solvents. The precipitate is slightly soluble in water and acidic ethanol solutions, such as 10 / 〇HC1 (in ethanol) and 0.1 10 /. HC1 (in ethanol / water (10 / 90, v / v)), and formed a very light to pale yellow solution and dark brown Shen Dian. It is insoluble in methanol, acetone and 1% HC1. It is soluble but slowly soluble in neutral phosphate buffered saline (PBS) , PH 7.2) It darkens a brown solution overnight. It dissolves quickly and completely in a 1% ΝΗβΗ solution (pH 10.4), which darkens quickly Brown solution. This confirms the above assumption that the active component is soluble in neutral or alkaline solutions but insoluble in acid solutions. Based on the solubility test, the active precipitate No. 5 (5) EA should be acid. The fact is that it is insoluble Alcohols (methanol, ethanol, isopropanol), propionate, and other general organic solvents (acetonitrile, CHCh, and hexane) suggest that it cannot be a pure organic acid such as benzoic acid. The fact is that it gradually becomes more soluble in aqueous solutions And increase the pH 値, indicating the transfer from its acid form to a more soluble salt form. In order to more clearly identify the active component number 5 (5) EA, the three waters number 5 (5) E were dried differently The eluate was extracted in the same way as the air-dried No. 5 (5) e_a used for the above HPLC fractions. One part was freeze-dried (FD) and two parts were air-dried (AD 1 and AD2). AD 1 and FD are _______- 76-This paper? ^ Degree Applicable Towel @ 1 | 家 标 ((^) 八 视 ^ (21 () \ 297mm) One '--- (Please read the notes on the back first_ Ben Gong). Order 1232104 A7 B7_ V. Description of the invention (74) Prepared from the same water-soluble chaotrope. AD2 is surprisingly found to be water-insoluble Partial (WI) was active. Each sample was dissolved in water at 100 mg / ml, and the soluble and insoluble were separated by centrifugation (1,500 rpm for 20 minutes). For fd and AD1, 1.20 g of the sample was dissolved. In 12.0 ml of water. For AD2, 0.567 g was dissolved in 5.67 ml of water. Each precipitate was extracted 3 times with the same amount of water. A 0.40 ml portion of each extract was dried with A and weighed. The remaining extracts were each pulverized at 0.45 microns, acidified with 1% HC1 (4 ml of acid vs. 10 ml of extract), and centrifuged (2,000 rpm for 20 minutes). The acid supernatant (AS) was filtered at 0.45 microns. The acid precipitate (AP) was washed twice with 10 liters of 0.01% 11 (1: 1: 卩 112.82) and twice with 10 ml of water '仏 -dried and weighed. Table 9 shows freeze-drying (FD) and air-drying ( ADI, AD2) pH of each water extract of No. 5 (5) EA * s, distribution weight of each extract and sediments 0/0, acid formation of each extract, and from each of No. 5 (5) % By weight of the combined acid deposits of EA. Printed by the Consumer Cooperatives of the Central Bureau of Standards of the Ministry of Economic Affairs _ _ -77- This paper size applies to China National Standard (CNS) A4 (210X297 mm) 1232104 A7 B7 V. Description of the invention (75) Table 9 Freeze-dried (FD) and air-dried (ADI, AD2) water extracts, water precipitates and acid precipitates of acidic precipitate No. 5 (5) EA fractions No. 5 (5) E-A's * Solution pH wt% Precipitation wt% First water extract 5.80 86.8% Second water extract 6.10 2.8% Third water extract 5.79 0.3% Fourth water extract 5.85 &lt; 0.3% Water precipitate __ 0.9% Some The amount has no trace i 8.5% ** AD1 first water extract 4.83 84.0% has 8.3% ** second water extract 5.14 3.8%-foot water third water extract 5.53 0.8% No fourth water extract 5.44 &lt; 0.3% Anhydrous precipitate — 3.1% — AD2 First water extract 3.21 77.3 ± 3.2% No 0.3% *** Second water extract 3.51 6.9 Soil 0.8 ° / 〇 No third Water extract 3.87 0.8 ± 0.4% — some water sediment — 9 · 4 ± 1 · 3% — printed by the Consumer Cooperative of the Central Bureau of Standards of the Ministry of Economic Affairs * with 100 mg / ml number 5 (5) EA (in water) ** Acid sinks from the combined first and second extracts. *** Acid precipitates from the combined third and fourth extracts. It clearly shows that the water extract of AD2 is better than ADI (pH's 4.8-5.5) and FD (pH, 5.8-6.1) are more acidic (pH 3.2-3.9). The AD2 sample contains more water-insoluble substances (9.4%) than AD1 (3.1%) and FD (0.9%). Water The more acidic the extract is, the larger the amount of insoluble matter is separated. When the water extract is acidified, the first and second extracts of FD and AD1 form -78-

This paper size applies the Chinese National Standard (CNS) A4 specification (210X297 mm) 1232104 A7 B7 5. Description of the invention (76) Forms a deposit, but AD2 does not. Alternatively, the third and fourth extracts of AD2 had an original pH of 3.9, forming some precipitates. Trace precipitates were observed in the third acidified extract of FD, while no precipitate was observed in the fourth extract of FD and the fourth extract of AD1. This indicates that the active precipitate is insoluble in water at pH 3.2-3.5, slightly soluble at pH 3.9, and becomes soluble above pH 4 · 8. Most of fd is soluble in water and its solution pH is 5.8-6.1. Only 0.9% remained insoluble. AD1, whose solution pH is 4.8-5.5, contains a little more insoluble matter or precipitate, 3 1 0 / 〇. Each solution of AD2 'has a pp of 3.2-3.9 and contains more insoluble matter or precipitates, 9.4%. When the water extracts of FD and AD1 were acidified, a precipitate (8 · 3_8 · 5%) was formed. The total precipitate of FD (9.4%) or AD1 (11.4%) is comparable to that of AD2 (9.7%). The weight% of the acid supernatant of the first extract obtained from freeze-drying No. 5 (5) ε_α or fd is 78 4%, which indicates that the rest is the first of the FD printed by the Consumer Cooperative of the Ministry of Economic Affairs of the Central Government Bureau Water extracts and precipitates, acid supernatants and acid precipitates of the first water extract of fd were tested for anti-HIV activity. The results are shown in Table 10, which clearly indicates that the active component of F D or lyophilization No. 5 (5) E-A was originally soluble in water and precipitated from an acid. The main activity of FD was in the water extract (at 0.3¾ g / ml, 89% inhibition on the 3rd day and 96% inhibition on the 4th day) rather than in the precipitate (at 0.3 mg / ml, the 13 and 4 days of inhibition). The main activity of the water extract was sequentially in the acid precipitate (0.3 mg / ml "97% inhibition on the 3rd day and 22% inhibition on the 4th day). Cytotoxicity factor (toxicity: At 0.3 mg / ml, 75% of the control group) apparently remains soluble in acid (cytotoxicity: at 0.3 mg / ml, the control group _____- 79-_ This paper standard applies Chinese National Standards (CNS) A4 specification (210 × 297 mm)-printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs 1232104 A7 B7 V. Description of the invention (77) 60%) and with active acid precipitates (cytotoxicity: 0.3 mg / ml 90% of the control group) are separable. Table 1 0 Anti-HIV activity of lyophilized No. 5 (5) EA (FD) part by weight% of FD test content (mg / ml) Toxicity 1 Anti-HIV activity 2 Day 3 Day 4 First water extract 86.8% 0.3 75% 89% 96% Water precipitate 0.9% 0.3 90% 13% 13% First water extract HC1 supernatant 78.4% 0.3 60% 4% 22% First water extract HC1 precipitate 8.5% 0.3 90% 97% 98%

1 Toxicity is expressed as% proliferation of the control group. 2 Activity is expressed as% inhibition of HIV proliferation based on viral protein p24 content. Therefore, it is assumed that the active ingredient of freeze-dried No. 5 (5) E_A is basically the same as the air-dried No. 5 (5) E-A, both of which are insoluble in acid. When No. 5 (5) E-A is freeze-dried, the active ingredient remains soluble in water and becomes insoluble when the solution is acidified. When the number 5 (5) E-A is air-dried, some or all of the active ingredients are acidified and become insoluble, as in the case of AD1 and AD2. The source of the acid is HC1 vapor obtained from the acidic alcohol / water portion, as the water and ethanol eluents (A and B) and acidic ethanol / water eluent (C and D) —start in the same gas cabinet and air dry. To prove this hypothesis, the active water precipitate of AD2 was re-dissolved in neutral and alkaline solutions and re-precipitated with acid. Therefore, a 50 mg sample of each precipitate was dissolved in 40 ml of PBS buffer (pH 7.2) or alkaline 1% NH4OH solution -80- This paper is again applicable to the Chinese National Standard (CNS) A4 specification (210X297) (Centi) 1232104 A7 ______B7_ V. Description of the invention (78)

(pH 10.4). The sample dissolves slowly in PBS buffer and is fast in 1% NH4OH solution. Even after being left in the refrigerator overnight, the two samples were not completely dissolved. The solution was centrifuged at 1,500 to 2,000 rpm for 40 minutes to separate soluble and insoluble matter. Each supernatant was passed through a 0.45 micron membrane. Each brown precipitate was washed with 10 ml of its respective solvent and then washed with 10 ml of water. The washing solution was centrifuged at 2,000 rpm for 20 minutes and separated and discarded. Each washed precipitate and 400 ml portions of each filtered supernatant was dried under N2 and weighed. At the same time, 4.00 ml of PBS buffer was dried for solvent blank calibration of the PBS supernatant. Printed by the Consumer Cooperatives of the Central Bureau of Standards, Ministry of Economic Affairs, 2 17.0 ml portions of each supernatant were drawn into separate 50 ml centrifuge tubes. One part was acidified by titration with 1% HC1 until a precipitate formed. The others were acidified by titration with 1% acetic acid and then 1% HC1 until a precipitate formed. Titration with 1/0 acetic acid alone was not enough to make the pΗ of the solution low enough to form a precipitate. The pH of the solution titrated with 1% ethanol reached a balance of about 3.4 to 3.8 without visible precipitates. 1% HC1 must be added to reduce the solution pΗ to approximately 1.5 to 1.8 to form a precipitate. It can be seen that Shen Dian began to form at a pH of about 2.2 to 2.5. When the supernatant was titrated at 1% HC1, the pH of the solution dropped to 1.4 and 1.5 and a sinker was formed. With HC1 titration, a precipitate started to form at about 2.3 for PBS supernatant and about 3.3 for NH4OH supernatant. Centrifuge for 20 minutes at 2,000 rpm to separate the acid supernatant and acid precipitate. Each acid supernatant (AS) was filtered through a 0.45 micron filter and dried over N2. Each acid precipitate (AP) was washed once with 5 ml of 1% HC1 and then dried with N2. Anti-HIV activity was tested with pbs supernatant and precipitates, acid (HC1) supernatant and precipitates from PBS supernatant, and acid (HC1) precipitates from NBUOH supernatant. Results show -81-This paper size is in accordance with Chinese National Standard (CNS) A4% grid (210X297 mm) 1232104 A7 B7 5. The invention description (79) is shown in Table 11. Table 1 1 Active air-dried part No. 5 (5) EA water-insoluble part (AD2-WI) part of AD2-WI part Anti-HIV activity test content Anti-HIV activity 1% by weight (mg / ml) toxicity 2 W4k on PBS Serum 72.3% PBS precipitate 28.9% PBS supernatant 47.9% HC1 supernatant PBS supernatant 52.8% HC1 precipitate NH40H supernatant 50.2% HC1 precipitate 0.3 0.3 0.3 0.3 0.3 100% 74% 50% 100% 92% 94% 98% 26% 34% 60% 65% 83% 93% Please read back &amp; precautions

92% 97% Printed by the Consumer Cooperative of the Central Bureau of Standards, Ministry of Economic Affairs 1 Activity expressed as% inhibition of HIV proliferation based on viral protein p24 content 0 The results clearly demonstrate that the active component of AD2-WI is available in PBS at pH 7.2, and It is soluble in 1% NH4OH at pH 10.4 and can be precipitated by acid. AD2-WI's PBS supernatant was very active (at 0.3 mg / ml, 94% inhibition on the third day and 98% inhibition on the fourth day), while the PBS pellet was the least active (at 0.3 mg / ml, the third 26% inhibition on day 4 and 34% inhibition on day 4). This is consistent with the observed activity of AD2-WI, whose active components have been dissolved in neutral cell culture medium for anti-HIV determination. The active component of AD2-WI was reprecipitated with HC1, and the HC1 precipitate from AD2-WI's PBS supernatant was quite active (at 0.3 mg / ml, 83% inhibition on day 3 and 92% inhibition on day 4) The HC1 supernatant is moderately active (at -82- this paper size applies the Chinese National Standard (CNS) A4 specification (210X297 mm)) 2 The toxicity is expressed in% of the proliferation of the control group. 1232104 A7 B7 V. Description of the invention (80) 0.3 g / ml, 60% inhibition on day 3 and 65% inhibition on day 4). The moderate activity of the HC1 supernatant can be partly attributed to cytotoxicity (50¾ of the proliferation of the control group) ° Acid precipitation of the active component of AD2-WI and HC1 of the NH4OH supernatant of the highly active AD2-WI Precipitation (at 03 mg / ml, 93% inhibition on day 3 and 97% inhibition on day 4) was confirmed. From this information, it can be concluded that the active component numbered 5 (5) E-A is soluble in neutral or test solutions and precipitates from acids such as HC1. Acetic acid, which can only reduce the pH of the solution to about 3.4 to 3.8, is not strong enough to cause precipitation of active components. This means that the active ingredient in its acid form is stronger than acetic acid and weaker than HC1. When neutralized by NHUOH, the active insoluble acid becomes a water-soluble salt, which is also active against HIV. Preparation of more active components printed by the Consumer Cooperatives of the Central Bureau of Standards of the Ministry of Economic Affairs by using water extract 5 # (5) E_A &quot; It was obtained by acid precipitation with 1% HC1 titration. The acid precipitate was washed with water and freeze-dried. The lyophilized acid precipitate was purified by re-precipitating with 0.1 N NH4HC03 and 1.5% by volume of HC1 (in water). For example, a 520.8 mg sample is completely dissolved in 20 ml 0.1 N NH4HC03. The solution was centrifuged at 2,000 rpm for 22 minutes, and the supernatant was filtered through a 0.45 micron filter. A portion of the solution was diluted with 0.1 N NHUHCCb to 20.0 ml to 18.7 mg / ml, which was then acidified with 30.0 ml of 1% HC1 (in water) to form a dark brown villi-like suspension and precipitates. The acidified solution was centrifuged at 2,000 rpm for 22 minutes. The acid supernatant was decanted and discarded. The acid precipitate was washed 6 times with 30 to 45 ml of 1% HC1 (in water). The pickling solution was separated from the precipitate by centrifugation at 2,000 rpm for 22 minutes each and discarded. Freeze-dried once-purified acid precipitate (AP1X) and __ -83- This paper size is in accordance with Chinese National Standard (CNS) 8 4 ^ grid (210X297 mm) 1232104 A7 B7 V. Description of the invention (81) Test resistance- HIV activity. The results showed that AP1X with activity number 5 (5) E-A remained active at 0.31 mg / ml; 75% inhibition on the third day and 87% inhibition on the fourth day. That is, anti-HIV activity overcomes the purification process.

2.Number 5 (5) E-C

Since the active component number 5 (5) EA has been identified as soluble in neutral and alkaline solutions and can be precipitated with HC1, it is logical to observe whether the active component number 5 (5) EC has similar characteristics. . Air-dried No. 5 (5) E-C contains two solids of different colors, one is brown and the other is dark to nearly black. The solubility test was performed by mixing 1.1-1.2 mg of the sample in 1 ml of each test vehicle. Air-dried No. 5 (5) E-C is insoluble in ethanol, isopropanol, acetone, acetonitrile, CHC13 and hexane. It is slightly soluble in methanol and partially soluble in water, 1% HC1 (in water), 1% HC1 (in ethanol), and 0.1% HC1 (in 10% ethanol / 90% water). It is most soluble in PBS, 0.1N NH4HC03, 1% NH4OH, and 1% NaOH (in water), with a small amount of non-pure white suspension or precipitate. Solubility shows a gradual increase as the solution is acidic to neutral to slightly alkaline, and then decreases in strong bases such as 1% NaOH (in water). Printed by the Consumer Cooperatives of the Central Bureau of Standards of the Ministry of Economic Affairs, air-dried No. 5 (5) EC (in water), PBS, 0.1 N NH4HC03, 1% NH4OH, and 1% NaOH in 1 ml solutions each filtered through Acidify 1.5 ml of 1% HC1 (in water). All acidified solutions turned yellow-brown to brown solutions and formed brown fluffy precipitates, except that no acidified aqueous solution was observed in the precipitates. In addition, air-dried No. 5 (5) E_C in 1% HC1 / water and 1 ml of 1% HC1 / ethanol in 1 ml of solution were each filtered through 0.45 microns and mixed with 1.5 ml of 1% NaOH-84- This paper size applies to China Standard (CNS) A4 specification (210X297 mm) 1232104 Printed by the Consumer Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs A7 B7 V. Description of the invention (82) The solution is made alkaline. The purpose is to observe whether these solutions contain an insolubility test. The test 1% HC1 / water solution turned into a yellow clear solution and the alkalized "/ 〇HC1 / ethanol solution turned a yellow label to a brown solution. After storing both in the refrigerator overnight, some golden brown fluffy precipitates were formed. 1ml solution of 5 (5) EC brown in 0.1% HC1 / 10% ethanol / 90% water is also alkalized in the same way but 1.5 ml of 1% NHWH is used. The brown solution changes to a light yellow clear solution after alkalization After storage in the refrigerator overnight, no precipitate was formed. The results indicate that acidic and alkaline substances can be separated from strong acid and strong base respectively and separated from No. 5 (5) EC. 100.4 mg of air-dried sample No. 5 (5) EC Dissolved in 20.0 ml of 0.1 N NH4HC03. The solution was centrifuged at 2,000 Γρη for 20 minutes, and the supernatant was transferred to a separate 50 ml centrifuge tube. The precipitate was drawn twice with 15.0 ml of 0.1 N NH4HC03. The supernatant was pooled (50 ml in total). Shen Dianwu was washed again with 15 ml of 0.1 N NH4HC03. The washing solution was centrifuged at 2,000 rpm for 30 minutes to separate and discard it. The precipitate was transferred to a WISP glass vial with 1 to 2 ml of water, 1 ^ 2 Dry and weigh 0.5 mg after drying, or 0.5% air-dried No. 5 (5) EC Start The supernatant was filtered through a 0.45 micron filter. The two 20.0 ml portions of the filtered supernatant were drawn into two 50 ml centrifuge tubes. The first 20 ml portion was 30 ml 1% HC1 (in (Water) acidified and formed a fluffy precipitate. The second 20 ml portion was made alkaline with 30 ml of 1% NaOH. The alkalized solution remained clear and there were no visible suspensions or precipitates after overnight storage in the refrigerator. The alkaline solution was also centrifuged at 2,000 rpm for 30 minutes or concentrated from 50 ml to 14 ml and centrifuged to keep it clear. Add another 20 ml of IN NaOH, _-85 -__ This paper size applies Chinese National Standard (CNS) A4 size (210 x 297 mm) (Please read the note on the back first)

Order 1232104 A7 B7 V. Description of the invention (83) Ensure that the solution is alkaline (pH 13.23, at 22.5.), Without any visible precipitation. The aged solution was centrifuged at 2,000 rpm for 30 minutes to separate the wool-like acid precipitate. The acid precipitate was washed 3 times with 20 ml of 1% HC1 (in water). Each wash was centrifuged at 2,000 rpm for 30 minutes and separated and discarded. The washed acid precipitates were freeze-dried, tested for anti-HIV activity and found to be active ... at 0.3 mg / ml, 76% inhibition on days 3 and 4. Air-dried No. 5 (5) E-C was directly dissolved in 1% HC1 (in water) fraction to prepare an acid-precipitable active component. The acid supernatant is made alkaline to prepare an alkali-precipitable component. 203.8 mg of air-dried sample No. 5 (5) E-C was dissolved in 20 ml of 1% HC1 (in water), and the suspension was vortexed 3 times for 1 minute. Centrifuge at 2.000 rpm for 30 minutes to separate the acid-soluble part and the acid-insoluble matter. The acid supernatant (red-brown solution) was filtered through a 0.22 micron filter. A 2.00 ml portion of the acid supernatant was dried with N2 and weighed 12.2 mg, or 59.9% of the air-dried starting material No. 5 (5) E-C. The remaining 18 ml of acid supernatant was basified with 7.5 ml of 1 N NaOH. After cooling in the refrigerator for about 5 minutes, a precipitate formed. The alkali precipitate was separated from the alkali supernatant by centrifugation at 2.000 rpm for 60 minutes. The alkaline supernatant was filtered through a 0.22 micron filter and neutralized with 5.0 ml 10/0 HC1 (in water) to pH 3.7 (clear brown solution). A 300 ml portion of the neutralized supernatant was dried with N2 and weighed 54.5 mg. The air-dried acid-insoluble portion of No. 5 (5) E-C was washed twice in 20 ml of 1% HC1 (in water). The alkali precipitate was washed once with 20 ml of 1% NaOH. The washed acid-insoluble part and the alkali precipitate were freeze-dried and weighed 666.6 mg and 18.6 mg, respectively, or 32.7% and -86 of air-dried number 5 (5) EC. CNS) A4 specification (210X297 mm) (Please read the note on the back page first) Printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs 1232104 A7 B7 5. Description of the invention (84) 10.1% The dried acid-insoluble portion, acid-soluble portion, test precipitate and neutralized alkali supernatant were air-dried with starting material No. 5 (5) E-C to test anti-HIV activity. The results are shown in Table 12, which also shows the weight% of each part of No. 5 (5) E-C. Table 1 2 Anti-HIV activity test content of air-dried No. 5 (5) EC part Anti-HIV activity No. 5 (5) EC part weight% (mg / ml) Toxicity ** Day 3 Day 4 No. 5 ( 5) EC 100% 0.31 89% 78% 76% acid insoluble matter 32.7% 0.30 91% 84% 85% acid soluble matter 59.9% 0.31 92% 12% 19% test precipitate 10.1% 0.31 90% 16% 20% test Serum *** 57.9% 0.30 99% 12% 10% Please read back

Page Printed by the Consumer Cooperative of the Central Bureau of Standards of the Ministry of Economic Affairs Activity is expressed as% inhibition of HIV proliferation based on viral protein p24 content. This data is a repeated result using a sample solution stored frozen for 3 months. Toxicity is expressed as% proliferation of the control group. Neutralize to pH 3.7 with 1% HC1 (in water) and dry with N2. The weight% shown does not include NaCl. The test sample contains 19.5% of part 5 (5) E-C. The results clearly demonstrated that the insoluble portion contained the main active portion of air-dried No. 5 (5) E-C. The acid-insoluble fraction is quite active: at 0,30 mg / mL, 84% inhibition on day 3 and 85% inhibition on day 4. The acid-soluble part has only minimal activity: 0.31 mg / ml, 12% inhibition on the third day, 氺 氺 * 氺 氺 87- This paper size applies the Chinese National Standard (CNS) A4 specification (210X297 mm) 1232104 A7 B7 5. Description of the invention (85) (Please read the notes on the back first \ 3 ^ write this page) 4 days 19 ° /. inhibition. The alkaline precipitate and alkaline supernatant of the acid-soluble part of No. 5 (5) E-C are also the least active: at 0.31 mg / ml, 12 to 16% on the third day, and 10 to 20% on the fourth day. Therefore, it is concluded that the active component numbered 5 (5) E-C, similar to the numbered 5 (5) E-A, can also be dissolved in neutral to microscopic solutions, but insoluble in strong acid solutions.

3. No. 5 (5) E Because of the main activity of No. 5 (5) E, the active components of C18-SPE-LC part A and C have similar solubility properties (soluble in neutral to alkaline solutions and can be precipitated in Among the strong acids), the main active component No. 5 (5) E can be prepared by direct acid precipitation of the water extract No. 5 (5). The acid precipitate can be further purified by redissolving in 0.1 N NH4HC03 and reprecipitating with HC1 one or more times. The NH4HC03 solution of the acid precipitate was filtered through a 0.22 micron or 0.45 micron filter in one of the purification cycles to remove the remaining insoluble particles. (6) The purified acid precipitate No. 5 (5) E or No. 5 (5) E-AP6X was tested for anti-HIV activity and found to be very active at 0.25 mg / ml, 99% inhibition on day 3 and no 97% inhibition at 4 days, as shown in Table 13. Among them, the anti-HIV activities of No. 5 (5) and crude No. 5 (5) E are shown for comparison. The% yield of No. 5 (5) E-AP6X from two determinations is also shown. Printed by the Consumers' Cooperative of the Central Bureau of Standards of the Ministry of Economic Affairs-88- This paper size applies to the Chinese National Standard (CNS) A4 specification (21 ×: 297 mm) 1232104 A7 B7 V. Description of the invention (86) Table 1 3 Number 4 ( 2), No. 4 (3), No. 4 (4), No. 5 (1), No. 5 (4), No. 5 (5), No. 5 (8), No. 5ΠΠ, 1, H water can be extracted (E), Acid Precipitable (AP) and Acid Soluble (AS) Partial Anti-ΗIV Activity Sample Batch Yield% ** Test Content Anti-HIV Activity * Toxicity *** Day 3 4th Ministry of Economic Affairs Printed by the Consumer Standards Cooperative of the Central Bureau of Standards

No. 4 (2) E No. 4 (2) E-AP No. 4 (2) E-AS No. 4 (3) No. 4 (3) E No. 4 (4) No. 4 (4) E No. 4 (4) E -AP number 4⑷E-AS number 4 (5) number 4 (5) E number 4 (5) E-AP number 4 (5) E-AS number 5 (1) number 5 (1) E number 5 (; 1) E-AP No. 5 (4) No. 5 (4) E No. 5 (5) Thick No. 5 (5) E No. 5 (5) E-AP6X No. 5 (8) No. 5 (8) E No. 5 (8 ) E-AP No. 5 (11) No. 5 (11) E No. 5 (11) -AP No. 5 (11) -AS GE-AP GE-AP6X HE-AP HE-AS HE-AP1X

0.30 ± 0.06% 100% 23.7% 0.39% 23.3% 100% 55.3% 100% 22.0% 2.1% 19.9% 100% 21.9% 0.19% 21.7% 100% 17.4 0.3% 0.30% 100% 12.8 ± 1.6% 100% 18 · 7 ± 2 · 80 / 〇1 · 6 ± 0 · 1% 100% 22 · 3 ± 3.1% 0.26% 100% 53.8% 4.36% 49.4% 1.0% 0.50% 2.5 ¾ g / milli 0.5 mg / ml 0.1 mg / ml 0.25 mg / ml 2.5 mg / ml 0.5 mg / ml 2.5 mg / ml 0.5 mg / ml 0.1 mg / ml 0.25 mg / ml 2.5 mg / ml 0.5 mg / ml 0.3 mg / ml 0.25 mg / ml 2.5 Mg / ml 0.5 mg / ml 0.3 mg / ml 2.5 mg / ml 0.5 mg / ml 2.5 mg / ml 1.0 mg / ml 0.25 mg / ml 2.5 mg / ml 0.5 mg / ml 0.1 mg / ml 2.5 mg / ml 2.0 mg / ml Jfj-0.3 mg / ml 0.5 mg / ml 0.30 mg / ml 0.25 mg / ml 0.30 mg / ml 0/25 mg / ml 0.25 mg / ml 74- 84% 68% 100% 69-90% 75- 78% 92% 74- 100% 67% 69% 75- 100% 41-79% 97% 86- 94% 91-96% 98% 100% 85-94% 64% 85% 80-84% 99% 63-98% 32-59% 69% 100% 100% 74-94% 73-100% 100% 33% 66-93% 83% 87- 9 1% 93-100% 92% 62% 83% 0% 100% 97% 100% 100% 85% 91% 98% 57% 86% 4% 73% 37% 62% 100% 52% 93% 91% 99% 100% 2% 45% 92% 87% 91% 84% 100% 100% 85% 24% 95% 94% 0% 83% 0% 100% 89% 100% 100% 95% 82% 92% 5% 80% 1% 50% 0% 74% 100% 0% 93% 97% 97% 100% 24% 61% 74% 73% 87% 65% 100% 99% 88% 0% 90% CNS) A4 specification (2H) X297 mm) -89-1232104 Printed by the Consumer Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs A7 B7 V. Description of the invention (87) * Activity is expressed as% inhibition of HI V proliferation based on viral protein P24 content 0 ** is derived from a single determination, except for those expressed in terms of the standard deviation of ± from 2 to 3 determinations. *** Toxicity was multiplied in the control group. / 〇 means. 4. GE. Test source plant G under No. 5 (5) to see if the same acid-precipitable anti-HIV active component can be isolated directly from the plant. Speaking of dried plant G from a local herbal store in Taiwan. A sample of 100.8 g was boiled for 75-76 minutes twice in 2,900 ml of water by drying the whole grass plants. &quot; Extract as-is &quot;. The first (~ 500 ml after evaporation) and second (~ 120 ml after evaporation) extracts were separated by pouring and filtering through Whatman No. 4 filter paper, respectively. The first extract was acidified with 400 ml of 1% HC1 (in water), and the second extract was acidified with 145 ml of 1% HC1 (in water). A precipitate was formed in the two acidified extracts (first 1) 11 1.5 and second 1.4). By centrifugation at 2,000 rpm for 30 minutes, the acid precipitate (dark and dark solid) and the acid supernatant (dark red-brown solution) were separated. Wash part of the acid precipitate of the first extract with about 30 ml of 1% HC1 (in water); then wash the inner wall of the 50 ml centrifuge tube with about 15 ml of water. Centrifuge at 2,000 rpm for 30 minutes, separate the acid wash and water wash from the acid precipitate and discard. The acid precipitate was dried over N2 (GE-AP), tested for anti-HIV activity and found to be very active; it was inhibited by 100% on days 3 and 4 at 0.30 mg / ml (Table 13). However, at this level, GE-AP is cytotoxic, 33% of the control group, and must be purified to reduce cytotoxicity. Cut boiled water into dried plant fragments of about 1 cm long with another -90- ^ Paper size applies Chinese National Standard (CNS) A4 specifications (210X297 mm) '' 1 (Please read the precautions on the back first ^^ (Write this page)-binding. Order 1232104 Α7 Β7 Printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs 5. Description of the invention (88) Re-extraction. The percentage extractables (%) of dried plant fragments measured from two batches of plants ranged from 21 to 27%. The water extract obtained from the fragmented sample was acidified with HC1 to give an acid precipitate, which was then dissolved up to 6 times as described above for No. 5 (5) E-AP6X and the cycle was purified by precipitation. The 6 purified GE-AP6X was tested for anti-HIV activity and was found to have activity as No. 5 (5) E-AP6X, as shown in Table 13. GE-AP6X showed 100% inhibition of HIV proliferation on the 3rd day at 0.25 mg / ml, 99% inhibition on the 4th day, and the same content of No. 5 (5) E-AP6X, 99% inhibition on the 3rd day, 4th 97% inhibition on day. Between the two active components, the toxicity test showed a close similarity, with the same 0.25 mg / ml, 66-93% for the GE-AP6X control group and 63-98% for the number 5 (5) E-AP6X. 5. HE. Plant tincture (Horseshoe gold) was originally considered to be the source of the single herb herbal number 5 (5), so the plant has the Chinese common name as herbal number 5 (5). See Η. C. Chang, Medical Herbs II, Holiday Publishing Company, Taipei, Taiwan, R.O.C., 27 (1991). Therefore, the plant salamander was subjected to water extraction and acid precipitation as described above for the plant G. The dried whole grass of the horseshoe gold (Η) was extracted with boiling water as described above for the plant G. The water extract was filtered and acidified with HC1 and a precipitate formed. The acid precipitate (HE-AP) and acid supernatant (HE-AS) were tested for anti-HIV activity. The results clearly show that the acid precipitate HE-AP is an active component of the water extract of the plant, as in the case of the plant G with the same number 5 (5), as shown in Table 13.

The acid precipitate HE-AP showed good anti-HIV activity: 0.30 mg / mL on day 3, 85% inhibition, and 88% inhibition on day 4. Acid Supernatant HE-AS -91-This paper size is applicable to Chinese National Standard (CNS) A4 specification (210X297 mm) (Please read the precautions on the back page first) • Installation · 1T 1232104 A7 B7 V. Invention Note (89) that there is no activity: at 0.25 mg / ml, 24% inhibition on the 3rd day and 0% inhibition on the 4th day. The once-purified acid precipitate from the second batch, ΕΕ-ΑΡχ, was also tested for activity ... at 0.25 mg / ml, 95% inhibition on the 3rd day and 90% inhibition on the 4th day (Table 13). For the content tested, the sample was not toxic. For HE-AP, the proliferation of the control group was 83%, for HE-AP1X, the control group was 100%, for 1 ^ -8, and for the control group, 87 to 91%. 6 · No. 4 (2), No. 4 (3), No. 4 (4), No. 2 No. 5 (1), No. 5 (4) and No. 5 (8) because of No. 5 (5) and Plant G It is logical that the active components of hydrazone are water-extractable and acid-precipitable. It is logical to see if the active components of other anti-HIV active single-herb herbs have similar properties. Therefore, check the active herbs to see if they contain acid-precipitable components, and if so, if they are active. Each 5.0 g sample of each single herb is numbered 4 (2), 4 (3), 4 (4), 4 (5), 5 (1), 5 (4), and 5 (8) Pump 50 ml of water twice into a plastic centrifuge tube printed by 50 ml of the Consumer Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs. Centrifuge at 2,000 rpm for 40 to 120 minutes to separate each extract from the insoluble material. The first and second extracts of each sample were combined and filtered through a 0.22 micron filter. A 2.00 ml portion of each extract was dried and weighed with N2. The remaining sample extracts were acidified with 10 ml of 1% HC1 (in water). Precipitates are formed in all acidified extracts, except those numbered 4 (3) and 5 (4). No precipitate was formed in the acidified extract No. 4 (3), even after extended (9 hours) storage in the refrigerator and adding 10 ml of 1% HC1 (in water). The acidified extract of No. 5 (4) showed only turbidity and after centrifugation at 2,000 rpm for 20 minutes, a trace amount of precipitate was formed. ___- 92-_ This paper size is in accordance with Chinese National Standard (CNS) A4 (210X297 mm) 1232104 A7 B7 V. Description of the invention (90) Centrifuge at 2,000 rpm for 20 minutes, separate each acid precipitate and the supernatant Separation. Each acid precipitate was washed with 5 ml of 1% HC1 (in water). The acid wash was centrifuged at 2,000 rpm for 20 minutes to separate and discard. Each acid precipitate was dried under N2 and weighed. Each acid supernatant was combined with 10 ml of 1% HC1 (in water). After 4 days of storage at ambient temperature, the supernatants were re-formed to varying degrees except for those numbered 4 (3). Centrifuge at 2,000 rpm for 80 minutes, filter through a 0.22 micron filter, separate each acid supernatant from the precipitate, and air-dry. Each air-dried acid supernatant was re-dissolved in 0.1 N NH4HC03, transferred to a WISP glass vial and freeze-dried. The dried water extracts (E), acid precipitates (AP), and acid supernatants (AS) of Nos. 4 (2), 4 (4), and 4 (5) were tested for anti-HIV activity. Water extracts (E) and acid precipitates (AP) were also tested under numbers 5 (1) and 5 (8). Because No. 4 (3) does not have acid precipitates and No. 5 (4) has only a small amount of acid precipitates (0.3 mg), only its water extract was tested for anti-HIV activity. The results are shown in Table 13. The printed results of the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs show that the water extracts No. 4 (3) and No. 4 (4) remain very active: at 0.5 mg / ml, for No. 4 (3) E, No. 3 Inhibition was 97% on day 4, 89% on day 4, and for number 4 (4) E, 100% on day 3 and 4. However, the activity of the water extracts No. 4 (2), No. 4 (5), No. 5 (1), No. 5 (4) and No. 5 (8) is surprisingly low: 0.5 at the same test content Mg / ml, 2 to 62% inhibition on day 3 and 0 to 24% inhibition on day 4. For comparison, the original herbal powder has moderate to very good activity: at 2.5 mg / ml, 73 to 100% inhibition on the third day, and 50 to 1,000 / day on the fourth day. inhibition. _ -93- This paper size applies Chinese National Standard (CNS) A4 (210X297 mm) ~ '1232104 A7 B7 V. Description of the invention (9 彳) Even more surprising, all acid precipitation (AP) shows medium to Good anti-HIV activity: 0.1 to 0.3 mg / ml, 83% inhibition on days 3 and 4 for number 4 (2) E-AP, 85% on day 3 for number 4 (4) E-AP Inhibition, 95% inhibition on day 4, for number 4 (5) E_AP, 86% inhibition on day 3, 80% inhibition on day 4, for VUE-AP, 62% inhibition on day 3, 80% on day 4 Inhibition, and for number 5 (8) E_AP, 45% inhibition on day 3 and 61% inhibition on day 4. The acid supernatant No. 4 (4) e was quite active, with 0.25 mg / ml, 91% inhibition on the 3rd day and 82% inhibition on the 4th day. The acid supernatants of No. 4 (2) E and No. 4 (5) E are practically inactive ... at 025 mg / ml, 0 to 4% inhibition on the 3rd day, and 0 to 1% inhibition on the 4th day . Because number 4 (2), number 4 (5), number 5 (1), number 5 (4) and number 5 (8) are much less active than their original powders, and number 4 (2 ), Acid Precipitates (AP) No. 4 (5), No. 5 (1) and No. 5 (8) are quite active, so it is assumed that most of the active components of these powders have been effectively pumped into water (pH 4.0 to 5.1 ·). It is expected that adjusting the pH of the solution to neutral or slightly alkaline will help improve the extraction. Printed by the Consumer Standards Cooperative of the Central Bureau of Standards of the Ministry of Economics The conclusions are that the active and component numbers 4 (2) and 4 (5) can be precipitated with acids. Active ingredient No. 4 (3) is soluble in water and acids. Number 4 (4) contains two active components, one is acid-soluble and the other is acid-precipitable. Numbers 5 (1) and 5 (8) contain active ingredients which can be precipitated by acids. 7. Number 5ΠΠ The single herb component numbers 5 (10) and 5 (11) are included in the herb mixture HHT888 · 5 for the treatment of HBV carriers (see Example 3). No. 5 (1〇) and No. 5 (11) are not included in earlier anti-EMuLV and anti-HIV screening tests_ -94- This paper size is applicable to China National Standard (CNS) A4 specification (21〇X: Z97 (Mm) &quot; '1232104 Α7 Β7 5. In the description of the invention (92), to prevent them from possibly interfering with the antiviral assay. The findings above show separation from single herb herbs and medicinal plants number 4 (2), number 4 (4), number 4 (5), number 5 (1), number 5 (5), number 5 (8) and tincture All acid-precipitable components or acid precipitates have anti-HIV activity. Therefore, it is deduced that the acid-precipitable component or acid precipitate, if it is isolated from other herbs or plants, is also anti-HIV activity. To test this hypothesis, the single herb herbs No. 5 (10) and No. 5 (11) were extracted with water, and the water extract was acidified with HC1 to see if an acid precipitate was formed. 90.4 g sample No. 5 (10) was pumped twice with 20 times water (1804 to 1808 ml) at ambient temperature, and then once with 900 ml of 0.1 NNH4HC03. A sample of 90.8 g was pumped twice with 10 times water (908 ml) at ambient temperature, and then pumped once with 870 ml of 0.1 N NH4HC03. The extraction was performed in a 2000 ml Erlenmeyer flask and magnetically stirred for 1 hour to overnight. The extract was separated from the insoluble matter by centrifugation at 8,000 rpm for 40 minutes. When 1.0 ml of the extract was acidified with 1.5 ml of 1% HC1 (water), the two water extracts of No. 5 (10) and the NH4HC03 extract were not even visible in the refrigerator after overnight storage in the refrigerator. The first water extract of No. 5 (11) turned brown and formed a precipitate almost immediately. The second water extract of No. 5 (11) became slightly yellow and slightly opaque, and after storage at ambient temperature overnight, a + amount of precipitate was formed. The NEUHCOs extract No. 5 (11) turned into a nearly colorless and white colloidal precipitate. It is expected that number 5 (11) and its acid precipitate may be anti-HIV activity. A 10 ml portion of each extract was freeze-dried and weighed. Number 5 (10) has a total extractables of 66.3%. The number 5 (11) is 53.8%. No. 5 (10) of -95- (Please read the notes on the back before filling in this page.) Installation ·-Ordered by the Consumers' Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs Printed on this paper The size of the paper applies to China National Standard (CNS) Α4 Specification (210 × 297 (Mm) 1232104 Α7 Β7 V. Description of the invention (93) Da Shao extractables are extracted with 2 times of water extraction, which constitutes 97.9% of the total extractables. The Da Shao extractables of No. 5 (11) were extracted in the first water extraction (93.5%). No. 5 (10), the second water extraction is necessary, which constitutes 31.2% of the total extractables. No. 5 (1, the second water extraction and NH4HC03 extraction only constitute 5.4% and 1.1%, respectively. The remaining 868 ml of the first water extract of No. 5 (11), the second of 898 ml The water extract and 828 ml of NH4HC03 extract were acidified with 14.6, 14.6, and 13.4 ml of concentrated HC1 (37%), respectively. The first acidified water extract formed a precipitate almost immediately. The second acidified water extract and ΝΙΙΙΙ0: The 〇3 extract became cloudy and formed a precipitate after overnight storage in the refrigerator. The acid precipitate (AP) of each acidified extract was centrifuged at 2,000 rpm for 40 minutes to separate from its acid supernatant (AS). The first and second The acid supernatant of the water extract was collected in a 2000 ml glass Erlenmeyer flask. A 2000 ml sample of each acid supernatant of the acidified water extract and NHUHCO3 extract was centrifuged at 8,000 rpm for 40 minutes and passed through 0.22 microns Filter membrane filtration. 20.0 ml of each micro-filtered acid supernatant was dried with N2, then dissolved in water and freeze-dried. Printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs (please read the precautions on the back first ^^ Writing Page) from acidified first and second water extraction And acidified NH4HC03 extract No. 5 (11) acid precipitate, washed twice with about 20 to 40 ml of water. The water washing solution was centrifuged at 2,000 rpm for 40 minutes to separate and discard. The acid precipitate was freeze-dried, weighed The yield percentage of acid precipitate is 4.36% of No. 5 (11). From the original powder, most of the acid precipitate (96.3%) is separated by the first water extraction. No. 5 (10), No. 5 (11), number 5 (10) or number 5 (10) E water extract, number 5 (11) or number 5 (11) E first water extract, from -96- this paper The scale is applicable to Chinese National Standard (CNS) A4 specification (21 × 297 mm) 1232104 A7 B7 V. Description of the invention (94) No. 5 (11) or No. 5 (11) E-AP acidified first water The acid precipitates of the extracts and acid supernatants of the acidified, aggregated first and second aqueous extracts obtained from No. 5 (11) or No. 5 (11) E-AS were tested for anti-HIV activity. The results (Table 13) showed that No. 5 (10) and its water extract No. 5 (ι〇) Ε were essentially inactive: at 2.5 mg / ml, for No. 5 (10), 65% on the third day Inhibition, 0% inhibition on day 4, and at 2.0 mg / ml, For the number 5 (10) E, the inhibition was 0% on the 3rd day and the 4th day. The number 5 (11), the water extract number 5 (11) E, and the acid supernatant number 5 (11) E-AS were Moderate activity: 2.5¾ g / ml, 92% inhibition on the 3rd day, 74% inhibition on the 4th day; 0.5mg / ml, number 5 (11) E_AS, 84% inhibition on the 3rd day, 65% on the 4th day inhibition. Acid precipitate No. 5 (11) E-AP was quite active again: at 0.3 mg / ml, it was 91% inhibited on the 3rd day and 87% inhibited on the 4th day. The results show that No. 5 (11) contains two active components, one is soluble in acid and the other is precipitated by acid. The two active components can be extracted with water since number 5 (丨). This supports a further aspect of the invention, since all acid-precipitable components or acid precipitates of selected plants and possibly any plant as described in this application are effective pharmaceutical agents. Example 10 Printed by the Consumer Cooperatives of the Central Bureau of Standards of the Ministry of Economic Affairs. The fractions of active ingredients 龅 Extract the powder from commercial sources or extract plants with water to isolate the active ingredients. Preferably, the amount added to the dried plant material ranges from 5 to 100 times (w / v), and extraction is performed at least twice. The extraction solution is preferably adjusted to neutral or slightly alkaline (7 to 8) with an alkaline solution such as NaOH to facilitate extraction. Extraction can be done weekly (commercial powder) or boiled (fragmented or powdered plants) for 1 hour

1232104 A7 B7 5. Description of the invention (95) or more.燊-(Please read the caution page on the back first) Separate soluble extract from insoluble plants by 遽 (ie nylon sieve and filter paper) or centrifugation (2,000 to 8,000 rpm for 40 minutes or longer) material. It is then acidified with any strong acid such as HC1 (about 0.6%, final concentration or solution PHS2) to obtain an active acid precipitate. Acid precipitates can be separated by centrifugation at 8,000 rpm for 40 minutes or longer. Shen Dianwu can be purified by repeated cycles of dissolution in neutral or test solutions such as 0.1 N NHUHCO3 and subsequent precipitation in acid. Insoluble matter can be removed by centrifugation (for example, at 40,000 rpm for 40 minutes or more) or microfiltration (for example, through a 0.2 to 0.45 micron diaphragm). The purified acid precipitate can be freeze-dried, dried under N2 or air-dried. It can also be converted into ammonium salt by dissolving the acid in ammonium salt solution such as NH4HC03 or NH40H solution, and then freeze-drying or spray-drying it. The purified acid precipitate can also be converted into other salts such as sodium salt by dissolving the acid in a suitable solution such as NaHC03. C18 column chromatography can also be used to separate the acid precipitate from the matrix. Printed on chemically relevant water extractables and acid-precipitable anti-HIV active components by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs from 7 anti-HIV active single herb herbs: No. 4 (2), No. 4 (3), No. 4 (5), No. 5 (1), No. 5 (5), No. 5 (8), No. 5 (11), and 2 kinds of medicinal plants wild pheasant (G) and horseshoe gold (h) (Identified in Example 5), and separated by the above-mentioned water extraction and precipitation method. As a special example, No. 4 (2), No. 4 (3), No. 4 (4), No. 4 (5), No. 5 (1), No. 5 (4), No. 5 (5) prepared according to Example 2 ), No. 5 (8) and No. 5 (11) are pumped twice with water at ambient temperature (about 25 \ :) to 8 to 10 ml of water per gram of sample (for example, 5 g of powder at 40 ml Water or 50 g of powder in 500 ml of water or 100 g of powder in 1000 ml of water) was pumped twice. Aqueous suspension -98- This paper size is in accordance with Chinese National Standard (CNS) A4 (210X297 mm) 1232104 A7 B7 V. Description of the invention (96) 1 vortex, then 1 vortex at 10 points; or Mix with magnetic stirring for 15 minutes or more (depending on sample size and suspension volume). For example, a suspension containing 5 g of powder in 40 ml of water is vortexed for 1 minute, put for 10 minutes and vortexed for 1 minute. A suspension containing 50 to 100 g of powder in 500 to 1000 ml of water is magnetically stirred for 15 minutes or more during extraction. Centrifuge at 1,500 to 8,000 rpm for 20 to 40 minutes and filter through a filter, such as Whatman No. 4 filter paper, to separate the water extract from the insoluble material. The medicinal plants wild coriander (G) and horseshoe gold (H), or the plants derived from herbal number 5 (5) and coriander, were washed with cold water, dried, and pulverized, and extracted with boiling water as described in Example 2 above. The water extract was cooled to ambient temperature and poured from and passed through a nylon sieve (1.3 x 1.5 mm holes), centrifuged at 1,500 to 8,000 rpm for 20 to 40 minutes, and then passed through Whatman No. 4 furnace paper to pass through insoluble plants. Material separation. The water extract is then acidified by adding HC1 to pHS2 to form a precipitate. Each acid precipitate is centrifuged in a plastic centrifuge tube or bottle and separated from the acid solution. Each acid precipitate was washed at least 3 times with water or 0.1 or 1% HC1. The water extract, acid precipitate (acid-insoluble component) and acid supernatant (acid-soluble component) of each sample were dried with N2, air-dried or freeze-dried. These samples were further tested and characterised. Therefore, the acid precipitates prepared and purified as described above are numbered 5 (5) E-AP1X, numbered 5 (5) E-AP6X, GE-AP1X, GE-AP2X, GE-AP6X, HE-AP1X, HE-AP6X, number 4 ( 2) E-AP1X, No. 5 (8) E-AP1X, No. 5 (11) E-AP1X, and its ammonium salt, No. 5 (5 for -Eight? 1 乂 _ ^ [114, 0 £ -AP2X-NH4 , HE-AP1X-NH4, No. 5 (8) E-AP1X-NH4, No. 99- This paper size applies to China National Standard (CNS) A4 specification (210X297 mm) Please read the notes on the back

Printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs 1232104 A7 B7 V. Description of the invention (97 Please read the note 5 (11) E-AP1X-NH4 and number 4 (2) E-AP1X-NH4. This article and application The nomenclature used in the scope of the patent can be described as follows: Dock No. 5 (5) E-AP1X means the single herb No. 5 (5) obtained from Noritake, extracting it with water (E), acid precipitation (AP), and borrowing Redissolved in neutral or alkaline solution and purified by acid reprecipitation once (IX), the final chemical entity is named No. 5 (5) E-AP1X. For example, the preparation of No. 5 (5) E-AP1X-NH4 First, wash 4.0 to 4.9 g of No. 5 (5) E-AP1X 4 times with 50 ml of water in a 50 ml centrifuge tube. Centrifuge at 2,000 rpm for 40 minutes to separate the water washing solution and discard it. Water-washed APIX's freeze-dried (A total of 11.4 grams), redissolved in about 600 ml of 0.1 to 0.2N NH4HC03. The solution was centrifuged at 2,000 rpm for 40 minutes, and the supernatant was filtered through a 0.45 micron filter under vacuum. The filtrate was freeze-dried, and thus prepared No. 5 ( 5) E-AP1X-NH4. Preparation of GE-AP2X_NH4 by dissolving 690.8 mg of GE-AP2X in 20.0 ml of 0.2 N NH4HC03. The solution was 8,000 rp Centrifuge at 40 ° C for 4 minutes. No precipitate was seen. The supernatant was filtered through a 0.22 micron filter. The filtrate was freeze-dried and thus GE_AP2X-NH4 was prepared. Other samples were prepared in a similar manner. Example 1 1 Staff Consumer Cooperative of the Central Standards Bureau, Ministry of Economic Affairs Characterization of printed active components 1. No. 5 (5) active component No. 5 (5) EA-AP and 5 (5) EC-AP, previously identified as active group No. 5 (5) It shows that based on their solubility, HPSEC, C18_SPE-LC and elemental analysis, these compounds are homogeneous polymerized organic acids. The two acids have similar properties, except that the molecular weight distribution and retention on the C18 column are -100- The paper scale is applicable to China National Standards (CNS) A4 (21 ×: 297mm) 1232104 A7 B7 Printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs 5. Inventive Note (98). The two acids are insoluble in acid aqueous solution However, it becomes soluble in salts in neutral and alkaline aqueous solutions. They are stable to air, acids, weak bases, and general organic solvents. As shown in Table 14, the acid precipitates purified after 6 purifications are numbered 5 (5) Elemental analysis of E-AP6X shows high C content (50.98%) and low Content (2.35%). This indicator number 5 (5) E-AP6X is an organic acid. SEM (Scanning Electron Microscope) X-ray surface element analysis indicator No. 5 (5) E-AP6X indicates C, 0, P, C1 And the existence of S. No As, Pb, Hg or Fe was detected. However, number 5 (5) E-AP6X and its component numbers 5 (5) EA-AP and 5 (5) EC-AP are insoluble in common organic solvents, including ethanol, isopropanol, acetone, acetonitrile, CHC13 and hexane. No. 5 (5) E-A-AP is also insoluble in methanol. This indicates that these active acid precipitates are not simple organic acids. Table 1 Elemental analysis and ash content samples of acid precipitates (AP6X) with 6 purifications of No. 5 (5) E, GE and HE.% C% H% N% S% C1% P% Ash No. 5 (5 ) Ε-ΑΡ6χ 50.98 4.92 3.69 0.14 4.69 &lt; 0.05 2.35 GE-AP6X 46.47 5.32 5.19 1.21 4.80 0.98 0.60 ΗΕ-ΑΡ6χ 54.69 5.20 3.52 0.66 4.22 1.18 1.99 All the acid precipitates studied were slightly soluble in water at a slow dissolution rate. All in a mixture of water and ethanol, such as water to ethanol in a 40 to 60 volume ratio, become more soluble and faster rates. This indicates that the acid precipitate is a polymeric property as supported by HPSEC analysis. Figure 1 shows the HPSEC side view of No. 5 (5) E-A-AP1X at the UV side of 214 nm, and Figure 2 shows the number 5 (5) E-C-AP. The column used for HPSEC analysis is a Varian MicroPak TSKgel-G3000 PWXL column (7 · 8 mm-101-this paper size applies to China National Standard (CNS) Α4 size (210X297 mm) (Please read the precautions on the back before (This page)

Order 1232104 A7 B7 V. Description of the invention (99) Inner diameter x 30 cm long), with TSK PWXL protection column (6.0 mm inner diameter x 4.0 cm long). The mobile phase was 0.1 N NH4HC03, and the flow rate was 0.80 ml / min. Samples were prepared at 0.92 to 0.93 mg / ml in mobile phase. The injection volume was 100 μl. The results show that number 5 (5) E-A-AP1X contains two UV absorption peaks, one is a peak with a smaller retention time at 7.55 minutes, and one is a larger and broader with a retention time at 9.55 minutes. The smaller peak dissolves at the leading edge of the main broad peak and contains larger molecules. There are also small wave crests riding on the trailing edge of the main broad peak. Number 5 (5) E-C-AP contains a main broad UV absorption peak with a residence time of 9.93 minutes, which is similar to the main peak of number 5 (5) E-A-AP1X. However, number 5 (5) E-C-AP does not have a peak containing macromolecules, unlike the main peak leading edge of number 5 (5) E-A-AP1X. No. 5 (5) EA-AP1X and No. 5 (5) EC-AP used HPSEC (High Pressure Size Exclusion Chromatography) under the above conditions, using 0.1 N NH4HC03 as the mobile phase, and fractions at a flow rate of 0.80 ml / min. . Each sample was prepared in mobile phase at 6.1 to 6.2 mg / ml and injected at 100 to 200 microliters per injection. 24 fractions were collected for each 30-minute chromatogram at 1.25 or 1.00 ml intervals. Figure 3 A shows the HPSEC UV side view of No. 5 (5) E-A_AP1X at 214 nm, and Figure 3B shows the RI side view. FIG. 4A shows the HPSECUV side view of No. 5 (5) E-C-AP at 214 nm and FIG. 4B shows the RI side view. The HPSEC part of No. 5 (5) EA-AP1X contains a black part, which reaches the highest in part 8 and has a residence time of 9.55 minutes on the UV side view (Figure 1) or on the RI side view (Figure 3 B). The main broad peak at 9.66 is consistent. The HPSEC part of No. 5 (5) EC-AP also contains a brown part, which reaches the highest in parts 8 and 9 and has a residence time of 9.93 minutes on the UV side view (Figure 2) or the RI side view (Figure 4B) -102- This paper size applies to Chinese National Standards (CNS) A4g (210X297 mm) (Please read the note before writing this page) Printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs 1232104 A7 B7 V. Description of the Invention (100) The main peak at 10.08 was consistent. A 1 ml portion of each of HPSEC sections 6 to 14 was analyzed with the injection volume of 100 microliters by the same HPSEC system. The results show that each part has different peak residence time, and the peak distributions of No. 5 (5) E-A-AP1X and No. 5 (5) E-C-AP are positive. Therefore, number 5 (5) E-A-AP1X and number 5 (5) E-C-AP are composed of polymers or oligomers having a relatively broad molecular weight distribution. HPSEC fractions No. 5 (5) E-A-AP1X, 1.30 ml fractions of parts 6 to 16 were dried individually or aggregated in a WISP vial with N2. The 1.31 ml portions of HPSEC portions 7 to 16 of No. 5 (5) E-C-AP were also dried with N2 in the same manner. The dried samples were tested for anti-HIV activity at a content equivalent to 0.30 mg / ml of their respective starting materials. No. 5 (5) E-A-AP1X was also tested at 0.31 mg / ml. Table 15 shows the anti-HIV activity of the HPSEC portion of 5 (5) E-A_AP1X and No. 5 (5) E-C-AP and their weight distribution percentages (%). Table 1 Anti-HIV activity and weight distribution% of HPSEC portion of No. 5 (5) E_Α · ΑΡ1χ and No. 5 (5) E-C_AP Please read the items on the back

Page order Printed HPSEC part of the Ministry of Economic Affairs Central Consumer Bureau Consumers' Cooperative Tests Anti-HIV activity *% by weight (mg / ml) *** Toxicity ** Day 3 Day 4 Number 5 (5) EA-AP1X 100% 0.31 98% 75% 87% No. 5 &amp; EA-AP1X-F6 8.3% 0.03 100% 19% 11% No. 5 (5 ^ EA-AP1X-F7 24.8% 0.08 93% 79% 78% No. 5 (5) EA-AP1X-F8 33.1% 0.1 94% 80% 83% number 5 (5 ^ EA-AP1X-F9 24.8% 0.08 100% 73% 69% number 5 ^ EA-AP 1X_F10 16.5% 0.05 100% 37% 14% number 5 ^^ EA-AP1X-F11 to F12 8.3% 0.03 100% 13% 21% No. 5 (5) EA-AP1X_F13 to Π6 8.3% 0.03 96% 9% 15% No. 5 ⑸E-C-AP-F7 8.3% 0.03 100% 0% 0% -103- This paper size is applicable to Chinese National Standard (CNS) A4 (210X297 mm) 1232104 A7 B7 Printed by the Consumers' Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs 5. Description of the Invention (1101) Number 5 (5) EC-AP-F8 16.7% 0.05 100% 95% 85% No. 5 (5) EC-AP-F9 16.7% 0.05 100% 98% 92% No. 5 (5) EC-AP-F10 25.0% 0.08 100 % 80% 35% No. 5 (5) EC-AP-F11 to F12 16.7% 0.05 100% 59% 8% No. 5 (5) EC-AP-F13 to F16 16.7% 0.05 100% 50% 0% activity is expressed as% inhibition of HIV proliferation based on viral protein p24 content. The anti-HIV activity data for No. 5 (5) EA-AP1X is the result of repeated use of a solution stored frozen for 3 months. ** Toxicity is The percentage of proliferation of the control group is expressed. *** The test content for the HPSEC fraction is equivalent to 0.30 mg / ml of the starting substance. The results clearly indicate that the main activity of the indication No. 5 (5) EA-AP1X is distributed within 3 parts of parts 7 to 9 And showed the highest 8 in the mass peak part (with 0.1 mg / ml, 80% inhibition on the 3rd day, 83% inhibition on the 4th day). The main activity of No. 5 (5) EC-AP is also distributed in the 3 parts Within, parts 8 to 10, and show the highest in parts 8 and 9 (at 0.05 mg / ml, 95 to 98% inhibition on day 3 and 92% inhibition on day 4). It should be noted that the mass of No. 5 (5) E_C-AP reached the highest in part 10, however, it had only the minimum activity, 0.08 mg / ml, 80% inhibition on the third day and 35% inhibition on the fourth day. . An HPSEC section of section 5 (5) E-C-AP, section 8, was found by ultrafiltration to contain oligomeric molecules with molecular weights between 1,000 and 3,000 channels. In the other HPSEC part, part 9 was found to contain polymer molecules with a molecular weight of more than 3,000 channels. Fraction 9 is more lipophilic than Fraction 8, because Fraction 9 contains larger molecules, but uses 0.1 N NH4HC03 as the mobile phase on HPSEC and dissolves later than Fraction 8. The two have been tested for comparable activity: 0.05 to 0.25 mg / ml against Part 8, 95% inhibition on the third day and 85% inhibition on the fourth day. For -104- Chinese paper standard (CNS) A4 applies Specifications (210X297 mm) (Please read the note on the back page first)-Packing. Ordering printed by the Consumers' Cooperative of the Central Bureau of Standards of the Ministry of Economic Affairs 1232104 A7 B7 V. Description of the invention (102) Part 9, Day 3 98% inhibition, 87 to 92% inhibition on day 4. In addition, HPSEC fraction 8 purified by secondary chromatography with number 5 (5) EC-AP showed a dose response to anti-HIV proliferation and IC5 of 6 μg / ml on day 3 and 17 μg / ml on day 4. (50% inhibitory concentration). The results are shown in Table 16. For comparison, when tested simultaneously, IC50 of AZT was 3 ng / ml on day 3, 21 ng / ml on day 4, and d4T was 32 nM on day 3 and 540 on day 4 nM. Table 1 6 Anti-HIV Activity Test Contents of HPSEC Parts 8 and 9 of EC-AP No. 5 (5) at Various Concentrations Anti-HIV Activity "HPSEC Part Weight% (mg / ml) Toxicity Day fraction 8 (first chromatography) 16.7% 0.05 100% 95% 85% secondary chromatography 10.3% 1.0 100% 93% 85% purified fraction 8 (second chromatography) 0.3 100% 85% 69% 0.1 100% 87% 79% 0.03 100% 89% 81% 0.01 100% 74% 32% 0.003 100% 19% 0% 0.001 91% 3% 5% Part 9 (first chromatography) 16.7% 0.05 100% 98 % 92% Part 9 / 2nd chromatography 23.6% 0.25 80-82% 91% 87%

1 Activity is expressed as% inhibition of HIV proliferation based on viral protein p24 content. 2 Toxicity is expressed as% of control group proliferation. Figure 5 A shows the HPSEC UV side view of the HPSEC portion 8 in two chromatographic purifications of No. 5 (5) E-C-AP at 214 nm, and Figure 5B shows the RI side view. HPSEC Part 9 of EC-AP No. 5 (5) dissolves slightly later than Part 8 and is similar to -105-This paper size applies Chinese National Standard (CNS) A4 (210X297 mm) 1232104 A7 B7 V. Description of the invention (103) However, the broader distribution and peak tailing of nonspecific interactions with column packing due to its lipophilicity. Each part was analyzed by HPLC. Figure 6 A shows the C18-HPLC UV side view of purified HPSEC part 8 at 214 nm at 5 (5) EC-AP. Figure 6B shows HPSEC part 9 using 0.1 N NH4HC03 with 30% ethanol as the mobile phase. Flow rate It was 0.8 ml / min. The HPLC column was a Rainin Microsorb-MV C18 column (5 micron particles, 100A pore size, 4.6 mm ID x 25 cm length). The sample was prepared in the mobile phase at 1.0 mg / ml and the injection volume was 5 μl. The results showed that purified fraction 8 (Figure 6A) contained a main peak with a retention time of 0.48 minutes and a lower lipophilic peak with a retention time of 2.24 minutes. Part 9 (Figure 6B) contains a main peak with a residence time of 2.56 minutes. The main peaks of the two parts 8 and 9 are very similar. The melting point (if any) of No. 5 (5) E-AP1X-NH4 and its purified HPSEC Part 8 was determined to be higher than 400 ° C. This is highly unusual because most organic compounds have a melting point of less than 300 ° C. Figure 11 shows the IR spectrum of the water-extractable and acid-precipitable active component of No. 5 (5) in its acid form (No. 5 (5) E-AP6X), and Figure 12 shows the ammonium salt form (No. 5 (5) E-AP6X-NH4). Samples were prepared in KBr slides and measured using a Perkin Elmer FT-IR spectrometer. The absorption of the acid forms at 1636, 1452, and 1402 cm · 1 indicates the C = C bond. Absorption at 2362 cm-1 indicates CO (gas), which may be a contaminant. The absorption band between 2850-2975 cnT1 indicates H-C-H (bend). No absorption below 60-700 cnT1 indicates no aryl group. The sensitive absorption peak at 698 cnT1 is derived from the calibration curve standard. The water-extractable and acid-precipitable active ingredient with number 5 (5) contains lipophilic substances -106- This paper size is applicable to China National Standard (CNS) A4 specification (210X297 mm) ~ (Please read the precautions on the back first : Write this page) Printed by the Consumer Cooperatives of the Central Bureau of Standards of the Ministry of Economic Affairs 1232104 A7 B7 V. The discovery of qualitative findings (104) is supported by HPSEC analysis (as described below) No. 5 (5) E-AP . 2. G and Η active components Plant G and Η active components are similar to those of No. 5 (5). Both are polymeric organic acids that are soluble in neutral and slightly alkaline aqueous solutions and are precipitated from the acid. Elemental analysis of the acid precipitates of the 6 purified GE and HE (Table 14) showed that both contained high carbon content (46.47 to 54.69%) and low ash content (0.60 to 1.99%). Figures 7, 13 and 17 HPSEC UV side view of 214 nm water extractable and acid-precipitable active components of No. 5 (5), G, and Tritium, respectively, using 0.3 N NH4HC03 with 30% acetonitrile as the mobile phase and a flow rate of 0.80 ml / Minute. The column was a Varian MicroPak TSKgel_G3000 PWXL column (7.8 mg ID x 30 cm long) and a TSK PWXL protection column (6.0 mm ID x 4.0 cm long). Samples were prepared in 0.3 N NH4HC03 at 0.65 to 1.4 mg / ml. The injection volume was 100 microliters. Figure 8 shows the HPSEC UV side view of the water-extractable and acid-precipitable active components of No. 5 (5) in the form of ammonium salt, or No. 5 (5) E-AP1X-NH4. Figure 14 shows G, or GE-AP2X-NH4, in the form of an ammonium salt. Figure 18 shows rhenium or HE-AP1X-NH4, also in the form of an ammonium salt. The mobile phase was 0.1 N NH4HC03 and the flow rate was 0.80 ml / min. The column was a Varian MicroPak TSKgel-G3000 PWXL column (7.8 mm ID x 30 cm long) with a TSK PWXL protection column (6.0 mm ID x 4.0 cm long). The sample is the ammonium salt of the active component, number 5 (5) E-AP1X_NH4 (Figure 8), GE-AP2X_NH4 (Figure 14) and HE-AP1X-NH4 (Figure 18), which are based on 0.1 N NH4HC03 -107 -This paper size is in accordance with Chinese National Standard (CNS) A4 (210X297 mm) (Please read the note on the back first_ This page) Printed by the Ministry of Economic Affairs of the Central Bureau of Standards for consumer cooperation print 1232104

Medium 'was prepared at 1.0 mg / ml. The injection volume was 50 μl. The molecular weights of the water-extractable and acid-precipitable active components numbered 5 (5), G, and gadolinium were evaluated by HPSEC analysis, and were between 1,000 and 12,000 ears, but some were less than 1,000. Ears. Figure 9 shows the gradient RP-HPLC UV side number 5 (5) E-AP1X-NY4, Figure 15 shows GE-AP1X-NH4 and Figure 19 shows QE-AP1X-NY4. The column was a PreSeptive Biosystems, POROS R2 / H column (4.6 mm internal technology x 10 cm long). The mobile phase was 0.1 N NH4HC03 containing acetic acid from 2% to 60% (according to the gradient described in Table 17) and the flow rate was 2.00 ml / min. The injection volume was 20 μl. Table 17 (Read the notes on this page) Note: Loading time RP-HPLC gradient solvent A / solvent B (v / v) * 〇 to 1 minute 100/0 1 to 7 minutes 100/0 to 50/50, Waters Convex Curve 7 7 to 1 3 points 50/50 to 0/100, Waters Convex Curve 5 1 3 to 20 points 0/100 20 to 30 points 100/0 Printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs * Solvent A = 0.1NNH4HCO3 with 2% ethanol (v / v) Solvent B = 0 · 1 N NH4HC03 with 60% ethanol (v / v) Figure 10 shows the number 5 (5) E-AP6X (Figure 10A), GE-AP6X ( Fig. 10B) and UV spectra of HE-AP6X (Fig. 10C) in NH4HC03 solution without solvent blank for correction. The three spectra are similar and have the maximum absorption between 204 and 206 nm. 〇-108-This paper is again applicable to the Chinese National Standard (CNS) A4 specification (210 X 297 mm) 1232104 A7 B7 5. Description of the invention (1〇 6) Figure 16 shows the IR spectrum of a water-extractable and acid-precipitable active component of G in the form of an ammonium salt (GE-AP2X-NH4). Figure 2 shows the HE-AP1X-NEU. Samples were prepared in KBr tablets and measured using a Perkin Elmer FT-IR spectrophotometer. 3. No. 4 (2), No. 4 (3), No. 4 (4), No. 4 (5), No. 5Π), No. 5 (8) and No. 5 (11) Activity of all tested samples The components are soluble in neutral cell culture medium. Active components numbered 4 (2), 4 (5), 5 (1), 5 (8), and 5 (11) can be acid precipitated, while those with numbered 4 (3) are not. Active ingredient No. 4 (3) is soluble in water and acid solutions. The active ingredient No. 4 (4) is also soluble in water. However, part of the active ingredient numbered 4 (4) can be acid precipitated but partly not. Figure 21 shows the HPSEC UV side view of the water-extractable and acid-precipitable active components of No. 5 (8) in the form of ammonium salt and No. 5 (8) E-AP1X-NH4. Figure 2 4 shows the number 5 (11) E-AP1X-NH4, and Figure 27 shows the number 4 (2) E-AP1X-NH4. The mobile phase was 0.1 N NH4HC03 and the flow rate was 0.80 ml / min. The column was a Varian MicroPak TSKgel-G3000 PWXL column (7.8 mm ID x 30 cm length) with a TSK PWXL column (6.0 mm ID x 4.0 cm length). Samples were prepared in 0.1 N NH4HC03 at 1.0 mg / ml. The injection volume was 50 μl. Fig. 22 shows a gradient RP-HPLC UV side view of No. 5 (8) E-AP1X · ΝΗ4. Fig. 25 shows the person numbered 5 (11) E-AP1X-NY4, and Fig. 28 shows the person numbered 4 (2) E-AP1X-NY4. The column was a PerSeptive Biosystems ’POROS R2 / H column (4.6 mm ID x 10 cm long). The mobile phase is 0 · 1 Ν -109- This paper size is applicable to Chinese National Standard (CNS) Α4 ^ grid (210 × 297 mm) (Please read the precautions on the back first • Installation-ρ page) Central of the Ministry of Economy Printed by the Consumer Bureau of Standards Bureau 1232104 A7 B7 V. Description of the invention (107) NH4HC03 contains 2% to 60% ethanol, according to the gradient described in Table 17 and the flow rate is 2.00 ml / min. The injection volume was 20 microliters. Figure 23 shows the IR spectrum of the number 5 (8) E-AP1X-NH4, and Figure 26 shows the number 5 (11) E-AP1X-NH4. Figure 29 shows the IR spectrum of No. 4 (2) E-AP1X-NH4. The samples were prepared in KBr plates and measured with a Perkin Elmer FT-IR spectrophotometer. The melting point (if any) of No. 5 (8) E-AP1X-NH4 is higher than 400 ° C. 4. Anti-HIV Active Dose Response and Toxicity As mentioned above, HPSEC part 8 purified by two chromatography methods with number 5 (5) EC-AP (also from the HPSEC side view of Figures 5A and B and C18- of Figure 6A- HPLC side chart specificization) showed dose-response activity to mv proliferation, as shown in Table 16 with IC50 of 6 μg / ml on day 3 and 14 μg / ml on day 4. Table 1 8 also shows water-extractable and acid-precipitable active components numbered 5 (5) E-AP1X-NH4, GE-AP2X-NH4, HE-AP1X-NH4, numbered 5 (8) E-AP1X-NH4 , No. 5 (11) E-AP1X-NH4 and No. 4 (2) E-AP1X · ΝΗ4 dose-response to their anti-HIV activity in the form of their ammonium salts. The dose response of AZT from two different determinations is presented for comparison. Printed by the Consumer Co-operation of the Central Bureau of Standards of the Ministry of Economic Affairs (please read the precautionary page on the back). GE-AP2X-NH4 has not been tested at 0.5 mg / ml because of its high cytotoxicity. %). Its cytotoxicity continued at lower levels: 0.25 mg / ml was used as a control for 34% of the proliferation, and 0.13 mg / ml was used for 41%. Number 4 (2) E-AP1X-NH4 also showed high cytotoxicity at 0.5 mg / ml (44% of control group proliferation), but became much less cytotoxic at lower levels: 0.25 mg / ml as control group 72% of the proliferation was 100% at 0.13 mg / ml (non-cytotoxic). -110- This paper size is in accordance with China National Standard (CNS) 8-4 specifications (210X297 mm) 1232104 A7 B7 Printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Economic Affairs 5. Description of the invention (108) No. 5 (5) 1 mg / ml or higher, its cytotoxicity to human PBLs in vitro: 1 mg / ml as the 55% of control group proliferation; 2 mg / ml as 46%, 5 mg / ml as 11%, And 10% and 20 mg / ml is 0%. No. 5 (5) E-AP6X showed microcytotoxicity (63% of control group proliferation) at 0.5 mg / ml and non-toxicity at 0.1 mg / ml and lower (with 0.1 mg / ml as The control group had 98% proliferation and 100% at 0.02 mg / ml). Part of the active component of No. 5 (5) E-AP, that is, chromatographically purified HPSEC Part 8 of No. 5 (5) EC-AP, has been shown to be non-cytotoxic: even with lo mg / ml as The control group had 100% proliferation (see Table 16). Study No. 5 (5) E-AP1X-NH4 for acute toxicity. Acute toxicity was measured in mice, and this compound was not found to be non-toxic even at 5,000 mg of test substance per kg body weight (administered orally-bolus). Four groups of i 0 groups of male ICR mice (weighing 18 to 21 grams each) were used for the acute toxicity test. Nine of the 40 mice died 72 hours after oral administration. The LD50 of No. 5 (5) E-AP1X-NH4 is higher than 5,000 mg / kg (oral administration, mouse, 72 hours). In addition, Test No. 5 (5) E-AP1X-NH4 has an effect of 5,000 mg / kg on the middle box nervous system of the test animals such as reflex depression, behavioral depression, muscle relaxation, motor stimulation, and the autonomic nervous system. When administered orally1 And after 3 hours, all were negative. -111-This paper size is in accordance with Chinese National Standard (CNS) A4 (210 X 297 mm) (Please read the precautions on the back first — — | page 1223104 Α7 Β7 5. Description of the invention (1〇9) Table 18 ^ No. 5 (5), No. 5⑻, No. 5 (n), No. 4 (2), 0 and $ in the form of ammonium salt water extractable and acid-resistant active ingredients _ΗΙΥ_ Content of the appropriate dose response test for anti-HIV activity. Active component (mg / milligram) Toxicity 1 2 Day 3 Day 4 IC50 No. 5 (5) E-ΑΡ1χ-ΝΗ4 0.5 0.05 &gt; 55% 98 % 81% 95% 75% 4.2 mg / ml (day 3) 0.005 53% 13% 16 mg / ml 0.0005 1% 0% (day 4) GE-AP2X-NH4 0.05 &gt; 41% 100% 96% 7.2 mg / ml 0.005 0.0005 40% 6% 8% 0% (day 3) 20 mg / ml 0.00005 3% 0% (day 4) 8.7 mg / ml ΗΕ-ΑΡΙχ-ΝΗ4 0.5 100% 92% 95 % 0.05 &gt; 89% 87% 95% (day 3) 0.005 33% 23% 8.3 mg / ml 0.0005 4% 0% (day 4) No. 5 (8) E-ΑΡ1χ-ΝΗ4 0.5 77% 99% 100% 9.5 mg / ml 0.05 100% 91% 92% (day 3) 0.005 30% 16% 1 0 mg / ml 0.0005 0% 0% (day 4) No. 5 (11) E-ΑΡ1χ-ΝΗ4 0.5 78% 98% 99% 11 mg / ml 0.05 &gt; 99% 91% 92% (day 3) 0.005 26% 11% 13 mg / ml 0.0005 12% 0% (day 4) No. 4 (2) E-ΑΡ1χ-ΝΗ4 0.5 44% 100% 100% 14 mg / ml 0.05 100% 88% 83% (day 3 ) 0.005 20% 0% 19 mg / ml 0.0005 2% 0% (Day 4) AZZ 0.1 ug / ml-99-100% 98-100% 2.0 ug / ml 0.01 ug / ml 87-93% 84% ( Day 3) 0.001 μg / ml 23-53% 0-26% 4.2 μg / Ailiter 0.0001 μg / ml 3-19% 0% (Day 4) Printed by the Consumer Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs 1 Inhibition of ΗI V proliferation based on the content of viral protein p 2 4 ° / 0 means 0 2 toxicity is expressed as% of control group proliferation. -112- This paper size applies Chinese National Standard (CNS) A4 specification (210 × 297 mm) 1232104 A7 B7 V. Description of the invention (11〇) 5. Stability of the active ingredient No. 5 (5), No. 5 (8) , No. 5 (11), No. 4 (2), G and rhenium water extractable and acid-precipitable active components are heat, air, strong acid and weak base such as HC1 and NH4HC03, ΝΗ4ΟΗ or NaHC03 and alcohol such as ethanol Is stable. They are active in acid or salt form, such as pressed or steel salts. No. 5 (5) E-AP1X-NH4 was still very active when stored at weekly temperature for 15.6 months (at 0.1 mg / ml, 94% inhibition on day 3 and 87% inhibition on day 4). GE-AP2X-NH4 and HE-AP1X-NH4 are still active when tested at 13 months after storage at ambient temperature (at 0.1 mg / ml, for GE-AP2X-NH4, 100% on days 3 and 4) Inhibition, for HE-AP1X-NH4, 83% inhibition on day 3 and 81% inhibition on day 4). No. 5 (8) E-AP1X-NH4 and No. 4 (2) E-AP1X-NH4 were tested after 12.5 months of storage at ambient temperature and remained quite active (at 0.1 mg / ml, for No. 5 (8) E -AP1X-NH4, 85% inhibition on day 3 and 81% inhibition on day 4 and for number 4 (2) E-AP1X-NH4, 92% inhibition on day 3 and 88% inhibition on day 4). No. 5 (11) E-AP1X-NH4 also remained quite active when tested at 12 months of storage at ambient temperature (at 0.1 mg / ml, 84% inhibition on day 3 and 78% inhibition on day 4). Printed by the Consumer Cooperatives of the Central Standards Bureau of the Ministry of Industrial Economics (please read the note on the back page first) This part of the invention is aimed at special medicinal plants or herbs or their mixtures with amazing antiviral activity. No damage was found to host cells. In addition, the present invention is directed to methods for treating humans and mammals infected with a virus such as HBV, HCV or HIV. The data provided in this application demonstrates identified compositions that have antiviral activity and are not toxic to host cells. From the previous experiments, it can be concluded that the herb mixture named HHT888-4 -113- This paper size is applicable to China National Standard (CNS) A4 specifications (210X: Z97 mm) 1232104 A7 B7

The substance is effective in treating HBV carriers and thus can be used to treat humans infected with HBV. The reduction in viral load in HBV patients and carriers results in prevention of HBV disease in adults and is also effective in treating humans showing HBV disease. Clinical trials have also shown that the herb mixture HHT888-45 is effective in treating patients with hepatitis C, and therefore it is expected to be effective in treating patients with hepatitis B when administered alone or in combination with HHT888-5 or its antiviral single herb component. In addition, ’HHT888-5, HHT888-45, HHT888-54 and individual anti-HIV activity single herb components have been shown to inhibit the proliferation of HIV in local human cells. In addition, HHT888-5, HHT888-45 and HHT888-54 have been shown to be effective in treating patients infected with HBV and HCV. 1 «1 丁 888-4‘ HHT888-5, HHT888-45, HHT888-54, water extracts and active ingredients are also effective in treating humans infected with HIV, including HVV carriers and AIDS patients. The therapeutic effects described herein can be through the administration of "as is" herbs, or with tea, decoctions, beverages, confections or other creams, enteral liquid nutritional products such as infant formula and adult nutritional products, medicinal foods, nutrition Supplements or nutritional products' contain more than one herb or their extracts or active ingredients. For pharmaceutical preparations, more than one of the above-mentioned antiviral herbs or their extracts or active ingredients can be administered in unit dosage forms such as capsules, sachets or lozenges (with or without a controlled release coating film). The medical community is constantly seeking methods and products that are effective in treating viral infections, especially those that treat humans infected with HB V, HCV and HIV. Herbal mixtures HHT888-4, HHT888-5, HHT888-45, -114- This paper size is applicable to China National Standard (CNS) A4 specification (210X297 mm) (Please read the precautions on the back ^^ write this page). Loading ·

1.1T printed by the Consumer Cooperative of the Central Standards Bureau of the Ministry of Economic Affairs 1232104 A7 B7 5. Description of the invention (112) HHT888-54, single herb components, their extracts, active ingredients and products containing herb compositions are easy for pharmaceutical groups Accepted as another tool to prevent and treat these devastating diseases. Although certain representative specific embodiments have been described herein, it is apparent that those skilled in the art can implement various changes and modifications without departing from the spirit or scope of the invention. Please read the back note first

Page Printed by the Employees' Cooperatives of the Central Bureau of Standards of the Ministry of Economic Affairs -115- This paper size applies to China National Standard (CNS) Α4 specification (210 × 297 mm)

Claims (1)

6 8% 1X2 32 month case &gt; 4-, one 'one sip 3 application (9 in the text, change the number for 5 to 969 into 10 spear please call 8 8 8 AB c D 6. Application for patent scope 1 · One for the treatment of viruses Infectious composition, including: a) AEGINETIAE HERBA, selected from at least one selected from the group consisting of Aeginetia indica, Dichondra micrantha, Striga lutea, and sunflower moss ( Dichondra repens) from whole plants; and b) at least one herb selected from the group consisting of: 0 SCUTELLARIAE BARBATAE HERBA, derived from at least one selected from Scutellaria barbata , Scutellaria rivularis and whole plants of Scutellaria dependens; ϋ) forsythia (FORSYTHIAE FRUCTUS), from at least one selected from the group consisting of Forsythia suspensa, gold Bell flower (Forsythia viridissima) and Han Lian Zhao (Forsythia koreana) plant fruit; 1 ii) Honeysuckle (LONICERAE FLOS), at least one selected from the group consisting of Lonicera japonica and soil Made from flower buds of plants of the Lonicera confusa; iv) PRUNELLAE SPICA, selected from at least one selected from the group consisting of Prunella vulgaris and Prunella vulgaris subsp. Asiatica Plants made of spica or whole grass; v) POLYGONI CUSPIDATI RHIZOMA, at least one selected from the group consisting of Polygonum cuspidatum, Polygonum cuspidatum, China Paper Standard (CNS) A4 Specification (210 X 297 mm) 1232104 AB c D Patent application scope Polygonum runcinatum and Polygonum reynoutria plant roots; vi) BLECHNI RHIZOMA, selected from at least one From Blechnum orientale, Osmunda japonica, Woodwardia orientalis, Woodwardia unigemmata, Athyrium acrostichoides, Sphaeropteris lepifera ) 'Made by Cyrtomium falcatum and Cyrtomium fortunei; vii) DRYOPTERIS CRASSIRHIZOMAE RHIZOMA Derived from plants of Dryopteris crassirhizoma; viii) LIGUSTRI FRUCTUS, derived from at least one plant selected from the group consisting of Ligustrum lucidum and Ligustrum japonicum Ix) SOLANI HERBA, made from whole plant of Solanum nigrum; X) LESPEDEZAE HERBA, made from plant of Lespedeza cuneata Xi) SENICINIS HERBA, made from Senecio scanden plants; and xii) HEDYOTIS, made from whole plants of Hedyotis diffusa ; Wherein the weight ratio of a) to b) is from 1:10 to 10: 1. -2-China National Standard (CNS) A4 for I (210X 297mm) 8 8 8 8 AB c D 1232104 6. Scope of patent application 2. The composition according to item 1 of the scope of patent application, including c) Guanzheng Guang; d) Beizhong, e) peperomia; f) Polygonum cuspidatum; g) Forsythia; h) Ligustrum; and i) Bozhi plus grass. 3. The composition according to item 2 of the scope of patent application, further comprising at least one component selected from the group consisting of: a) CIRSII RHIZOMA ET RADIX, which is derived from at least one selected from Cirsium japonicum , Cirsium albescens and Cirsium japonicum var. Australe plant rhizome or root or whole plant; b) thistle (BREEAE RADIX), from at least one selected from the group consisting of small thistle (Breea segetum) and the root of the plant of Breea setosum; c) BAPHICACANTHIS RHIZOMA ET RADIX, at least one selected from the group consisting of Baphicacanthes cusia, Strobilanthes cusia, and Daqing Isatis tinctoria), Isatis indigotica, and Polygonum tinctorium; rhizomes or roots of plants; d) Scutellaria baicalensis (PHELLODENDRI CORTEX), at least one selected from Phellodendron amurense including Phellodendron amurense chinense), Japanese yellow rice (Phellodendron -3-) This paper size applies to China National Standard (CNS) A4 size (210 X 297 mm) 1232104 A 8 B8 C8 Patent scope: amurense var · sachaHnense) and the cortex of plants of pheU〇dend_ wilsonii; and e) BLETILLAE TUBER, which is made from the tubers of Bletilla striata Got. 4. A composition according to item 1 of the patent application scope, which includes: a) Guanzheng Guang; b) honeysuckle; c) prunella vulgaris; and d) peperomia. 5. The composition according to item 4 of the patent claim, further comprising at least one ingredient selected from the group consisting of: a) Scutellaria barbata; and b) forsythia. 6. Composition according to claim 1, 2, 3, 4 or 5, wherein the composition is a type of beverage, capsule, lozenge, powder, candy, gel, nutritional product or pharmaceutical product. 7. The composition according to item 1 of the patent application, wherein the weight ratio of a) to b) is from 1: 5 to 5: 1. 8. · A composition for treating an individual with a viral infection selected from the group consisting of hepatitis B virus (HBV), hepatitis C virus (HCV), leukemia virus (lv) and human immunodeficiency virus (HIV) ), The medicine includes at least one herb selected from the following groups: (a) SOLANI HERBA, which is prepared from the whole plant of Solanum nigrum; -4- This paper standard is applicable to China Standard (CNS) A4 specifications (21 × 297 public directors) 装 -ΤΓ 1232104 A8 Β8 C8 ____________D8_ VI. Scope of patent application (b) Lespedezae HERBA, which is made from the whole plant of Lespedeza cuneata; (c) Senecinis HERBA, which is from Qianliguang (Senecio scandens) whole plant; (d) Ligustrum fruit (LIGUSTRI FRUCTUS), from at least one selected from the fruits of the plant including Ligustrum lucidum and Ligustrum japonicum. 9 · The composition according to item 8 of the scope of patent application, further comprising at least one herb selected from the group consisting of: (a) HEDYOTIS, a whole plant derived from Hedyotis diffusa (B) SCUTELLARIAE BARBATAE HERBA, from at least one plant selected from the group consisting of Scutellaria barbata, Scutellaria rivularis, and Scutellaria dependens Made from whole plants; (c) LONICERAE FLOS, made from at least one flower bud selected from plants including Lonicera japonica and Lonicera confusa; (d) Prunella vulgaris (PRUNELLAE SPICA), which is prepared from at least one flower spike or whole plant selected from the group consisting of: Prunella vulgaris and Prunella vulgaris subsp. Asiatica; (e) BLECHNI RHIZ0MA, from at least one selected from the group consisting of Blechnum orientale, Osmunda japonica, Woodwardia orientalis, and Single Bud Dog Ridge (Woodwardia -5- this paper) Standards are applicable to Chinese National Standard (CNS) A4 specifications (210 X 297 mm) 1232104 Λβ B8 C8 ~-~ —_2! __ VI. Application scope of patents (unigemmata), Athyrium acrostichoides, Amorphaceae (Sphaeropteris lepifera), Cyrtomium falcatum and Cyrtomium fortunei; (f) DRYOPTERIS CRASSIRHIZOMAE RHIZOMA, from at least one selected from the group consisting of Dryopteris crassirhizoma, Osmunda japonica ), Woodwardia orientalis, Woodwardia unigemmata, Athyrium acrostichoides, Sphaeropteris lepifera, Cyrtomium falcatum and Cyrtomium fortunei Obtained; (g) CIRSII RHIZOMA ET RADIX, from at least one rhizome of a plant selected from the group consisting of Cirsium japonicum, Cirsium albescens, and Cirsium japonicum var. Australe or Made from roots or whole plants; (h) BREEAE RADIX, selected from at least one selected from the group consisting of Brea seget um) and the roots of the plants of Breea setosum; (i) AEGINETIAE HERBA, selected from at least one selected from the group consisting of Aeginetia indica, Dichondra micrantha, and Striga lutea) and whole plant of Dichondra repens; (j) BAPHICACANTHIS RHIZOMA ET RADIX, at least one selected from the group consisting of Baphicacanthes cusia and Strobilanthes cusia , Isatis tinctoria, Isatis indigotica and Polygonum tinctorium-6-This paper size applies to China National Standard (CNS) A4 (210 X 297 mm) 8 8 8 8 AB c D 1232104 6. Obtained from the rhizomes or roots of the scope of patent application; (k) Polygonum cuspidatum RHIZOMA, at least one selected from the group consisting of Polygonum cuspidatum, Polygonum runcinatum, and Polygonum reynoutria); (l) FORsyTHIAE FRUCTUS, selected from at least one selected from the group consisting of Forsythia suspensa and Forsythia suspensa sythia viridissima) and forsythia koreana; (m) PHELLODENDRI CORTEX, at least one selected from the group consisting of Phellodendron amurense, Phellodendron chinense, Phellodendron amurense var. Sachalinense and Phellodendron wilsonii plant cortex; and (η) white pupa (BLETILLAE TUBER), made from tubers of Bletilla striata. 10. A composition according to item 9 of the scope of patent application, which comprises: (a) Bozhica grass; (b) Scutellaria barbata; (c) Honeysuckle flower; (d) Prunella vulgaris; and (e) Dragon sunflower. 11. The composition according to item 10 of the scope of patent application, wherein the weight ratio of a: b: c: d: e is about 3: 3: 3: 3: 4. This paper size applies to China National Standard (CNS) A4 specifications (210 X 297 public directors) 8 8 8 8 A BCD 1232104 々, patent application scope 12. Composition according to item 9 of the patent application scope, which includes: (a) Bo Zhi Jia Cao (b) Guan Zhenguang; (c) Isatis indigotica; 虎 Polygonum cuspidatum; (e) Lian Nian; ⑴ Huang Zhi; (g) Bai Zhi; and (h) Ligustrum lucidum 13. According to the 9th item of the scope of patent application A composition comprising: (a) honeysuckle; (b) prunella vulgaris; (c) guanzhenguang; and (d) at least one herb selected from the group consisting of euphorbia buds and arrow grass. 14. A composition according to item 9, 10, 12 or 13 of the scope of the patent application, wherein the agent is administered to humans in an amount of 0.4 to 120 grams per day. 15. A composition according to item 9, 10, 12, or 13 of the scope of the patent application, wherein the medicament is in the form of a beverage, capsule, lozenge, powder, candy, colloid, nutritional product or pharmaceutical product. 16. A composition for treating an individual having a viral infection, the viral infection being selected from the group consisting of ΗIV, LV, and HCV, and the agent comprising at least one herb selected from the group consisting of: (HEDYOTIS), prepared from the whole plant of Hedyotis diffusa; This paper size applies to Chinese National Standard (CNS) A4 (210 X 297 mm) 1232104 as Β8 C8 _ _____ D8 VI. Application Patent scope (b) AEGINETIAE HERBA is from at least one group selected from the group consisting of wild It (Aeginetia indica), horseshoe gold (Dichondra micrantha), striga lutea and dichondra repens (C) SCUTELLARIAE BARBATAE HERBA, selected from at least one selected from the group consisting of Scutellaria barbata, Scutellaria rivularis, and Scutellaria dependens ) Of the whole plant; and (d) FORsythiae Fructus, selected from at least one selected from the group consisting of Forsythia suspensa, Forsythia viridissima, and Han Lianmian ( Forsythia koreana). 17. The composition according to item 16 of the scope of patent application, wherein the medicament comprises: (a) AEGINETIAE HERBA; and (b) at least one herb selected from the group consisting of: i) Scutellaria Ii) Bozhica grass; Hi) Forsythia; iv) Honeysuckle is made from at least one flower bud selected from plants including Lonicera japonica and Lonicera confusa; v) Prunella ( PRUNELLAE SPICA), at least one selected from the group consisting of Prunella vulgaris and Japanese prunella herb paper. Applicable to China National Standard (CNS) A4 (210 X 297 mm) AB c D 1232104 6. Scope of patent application (Prunella vulgaris subsp. Asiatica) plant made of spica or whole grass; vi) Polygonum cuspidati RHIZOMA, at least one selected from Polygonum cuspidatum, Polygonum runcinatum And Rhizome of Polygonum reynoutria; vii) BLECHNI RHIZOMA, selected from at least one selected from Blechnum orientale, Wei (O smunda japonica), Woodwardia orientalis, Woodwardia unigemmata, Athyrium acrostichoides, Sphaeropteris lepifera, Cyrtomium falcatum and Cyrtomium fortunei Plants; and viii) DRYOPTERIS CRASSIRHIZOMAE RHIZOMA, made from plants of Dryopteris crassirhizoma. 18. A composition according to item 17 of the scope of patent application, wherein the medicament is administered to humans in an amount of 0.4 to 120 grams per day. 19. The composition according to item 17 of the scope of patent application, wherein the weight ratio of (a) to (b) is 1:10 to 10: 1. 20. The composition according to item 17 of the scope of the patent application, wherein the medicament is in the form of a beverage, capsule, lozenge, powder, candy, colloid, nutritional product or pharmaceutical product. -10- This paper size applies to China National Standard (CNS) A4 specifications (21G X 297 public directors)