CN1281701A

CN1281701A - New medicine for curing chronic hepatitis B and its preparation method

Info

Publication number: CN1281701A
Application number: CN 00101383
Authority: CN
Inventors: 李承栋
Original assignee: Individual
Current assignee: Individual
Priority date: 2000-02-18
Filing date: 2000-02-18
Publication date: 2001-01-31

Abstract

The medicine for curing chronic hepatitis B is a Chinese herbal medicine compound preparation made up by using 14 Chinese medicinal materials of astragalus root, bighead atractylodes rhizome, cordyceps, schisandra fruit, maganshi, notoginseng root, salvia root and others. Said invented medicine possesses the functions of inhibiting and eliminating hepatitis B virus, regulating immunity of body, protecting liver cell and resisting fibrosis of liver, and it is a tablet preparation, convenient for taking, good in taste and low in cost.

Description

A kind of new drug and preparation method for the treatment of chronic hepatitis B

The present invention relates to a kind of new drug for the treatment of chronic hepatitis B, specifically a kind of Chinese herbal compound preparation.The invention still further relates to the manufacture method of this medicine.

Hepatitis B is a kind of disease that is global distribution, and according to World Health Organization's investigation, the whole world has more than 100 ten thousand people to die from the hepatitis B disease every year.China is high incidence of hepatitis b, and hepatitis b virus infection ratio is 42%--80.7% among the crowd in all parts of the country, and wherein has 1/4 hepatitis B virus carriers finally to develop into liver cirrhosis and primary hepatocarcinoma approximately, accounts for the over half of world's hepatitis B patient.Chronic hepatitis B is that a kind of many internal organs are got involved simultaneously, and the function performance is low, the pathogenesis complexity, and the course of disease is long, and easily repeatedly, difficult smelting is healed, the disease that social harm is big.Modern medicine does not still have specific medicament to the treatment of hepatitis B, though existing have antiviral agent such as interferon, adenine arabinoside and acycloguanosine that certain curative effect is arranged, it has strict indication, the expense costliness, side effect is more, and most patients are difficult to bear, difficult the popularization.Though present existing many progress of Chinese traditional treatment chronic hepatitis B are as improving falling enzyme, jaundice eliminating, improve albumen and collagenic supersession aspect the liver function; At the promotion cell growth that improves aspect the hepatic pathology, fibrosis; Raising non-specific cell immunologic function, reduction autoimmune response and removing immune complex at the regulation and control immunology; Aspect screening anti-hepatitis virus Chinese herbal medicine, entered from the laboratory in vitro study and studied in the clinical body etc., but all non-breakthrough.As existing new drugs such as the YIGANNING CHONGJI of clinical practice, 25-component tophus ball, Herba Abri pill, YIGAN SAN, hepatitis B detoxifying capsule, effect of its treatment hepatitis B is still unsatisfactory, its definite curative effect still need further research and checking.The treatment key of chronic hepatitis B is inhibition and removes hepatitis B virus, adjustment immunity of organism, protection hepatocyte, blocking-up chronicity (hepatic fibrosis); still there is not desirable medicine so far; long for solving above-mentioned contradiction at one stroke, medical circle is in theory still all had any problem in practice both at home and abroad at present.Therefore, how to seek reliable medicine of curative effect and therapeutic scheme and be still the difficult problem that the clinicist suddenly expects solution.

The object of the present invention is to provide a kind of have suppress and remove hepatitis B virus, adjust immunity of organism, protection hepatocyte, blocking-up fibrosis effect, to treatment chronic hepatitis B obvious results Chinese herbal compound preparation.Another object of the present invention provides the preparation method of this Chinese herbal compound preparation.

The objective of the invention is to realize that by following technical proposals a kind of medicine for the treatment of chronic hepatitis B is the medicament of being made by the following weight proportion raw material.

Radix Astragali 600--900 part Rhizoma Atractylodis Macrocephalae 450--600 part Cordyceps 60--90 part

Fructus Schisandrae Chinensis 60--90 part Hepar Equi stone 600--900 part Radix Notoginseng 60--120 part

Radix Salviae Miltiorrhizae 300--450 part Cacumen Securinegae Suffruticosae 180--300 part Rhizoma Polygoni Cuspidati 600--900 part

Herba Turczaninowiae Fastigiatae 600--900 part Radix Apioris Fortunei (Radix Lespedezae Buergeri) 300--450 part Fructus Amomi 30--60 part

Ramulus et Folium Phyllodii Pulchelli 300--450 part Periostracum Cicadae 300--450 part

Medicine preferred weight proportioning of the present invention is:

90 parts of 60 parts of Fructus Schisandrae Chinensis of 450 parts of Cordyceps of 900 parts of Rhizoma Atractylodis Macrocephalaes of the Radix Astragali

180 parts of 300 parts of Cacumen Securinegae Suffruticosaes of 120 parts of Radix Salviae Miltiorrhizaes of 900 portions of Radix Notoginsengs of Hepar Equi stone

30 parts of 450 parts of Fructus Amomis of 900 parts of Radix Apioris Fortunei (Radix Lespedezae Buergeri)s of 600 parts of Herba Turczaninowiae Fastigiatae of Rhizoma Polygoni Cuspidati

300 parts of 450 portions of Periostracum Cicadaes of Ramulus et Folium Phyllodii Pulchelli

The preparation method of medicine of the present invention is:

1, takes by weighing each raw material by formula proportion;

2, Cordyceps, Fructus Schisandrae Chinensis, Radix Notoginseng, Cacumen Securinegae Suffruticosae, Fructus Amomi were pulverized 100 mesh sieves;

3, the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Hepar Equi stone, Radix Salviae Miltiorrhizae, Rhizoma Polygoni Cuspidati, Herba Turczaninowiae Fastigiatae, Radix Apioris Fortunei (Radix Lespedezae Buergeri), Ramulus et Folium Phyllodii Pulchelli, Periostracum Cicadae are ground slightly not, the decocting secondary, 4 hours for the first time, 3 hours for the second time, filter, filtrate is condensed into thick extractum, drying was pulverized 100 mesh sieves, added summer in winter grass, Fructus Schisandrae Chinensis, Radix Notoginseng, Cacumen Securinegae Suffruticosae, Villous Amomum Fruit, mixing, compacting in flakes or incapsulate.

Tablet of the present invention is a ZONGHUI black tablet, the tool aromatic odor, and bitter in the mouth, little acid, nontoxic, be pure Chinese herb compound tablet, temporary called after " hepatitis B recuperating medicine sheet " or " hepatitis B recuperating medicine capsule ".

Medicine of the present invention is through clinical trial certificate: Cacumen Securinegae Suffruticosae, Rhizoma Polygoni Cuspidati, Herba Turczaninowiae Fastigiatae, Hepar Equi stone, Radix Apioris Fortunei (Radix Lespedezae Buergeri), Radix Salviae Miltiorrhizae, Ramulus et Folium Phyllodii Pulchelli have obvious inhibition and scavenging action to hepatitis B virus; Radix Salviae Miltiorrhizae, Radix Notoginseng, Rhizoma Polygoni Cuspidati, Ramulus et Folium Phyllodii Pulchelli removing heat from blood and promoting blood circulation, removing blood stasis to reduce swelling can improve the cell oxidation resistance, alleviates the membrane lipid peroxidating, the stabilized cell structure, reduce erythrocyte aggregation, remove small thrombosis, improve liver microcirculation, accelerate hepatocellular oxygen supply, accelerate the drainage of metabolite, recover hepatocellular homergy and blood supply, promote the reparation and the hepatocellular regeneration of hepatic injury; The Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Hepar Equi stone, Cordyceps, Fructus Amomi replenishing QI to invigorate the spleen, the kidney invigorating nourishing the liver, the scalable immune function of human body, enhancing immunity, the activity of immune factors such as raising human serum interferon, interleukin II, help removing hepatitis B virus, and can improve blood oxygen carrying capacity; Cordyceps, Ramulus et Folium Phyllodii Pulchelli can make liver collagen content, degree of hepatic fibrosis, hyaluronic acid contents etc. obviously descend, and have good effect of anti hepatic fibrosis; Fructus Schisandrae Chinensis, Rhizoma Polygoni Cuspidati have protection liver plasma membrane integrity, recover hepatocyte function, adjust immunity function, above-mentioned many medicines share makes the effect that medicine of the present invention has good replenishing QI to invigorate the spleen, the kidney invigorating nourishing the liver, removing pathogenic heat from blood and toxic substance from the body, expelling wind and removing dampness, promoting blood circulation to remove obstruction in the collateral, inhibition and removing hepatitis B virus, adjustment antibody mediated immunity, protection hepatocyte, stops fibrosis, especially very remarkable to treatment chronic hepatitis B curative effect, be characterized in: 1. suppress and to remove the hepatitis B virus effect strong, 6 months HBsAg negative conversion rates of medication can reach more than 50%; 2. be All Pure Nature pharmaceutical preparation, do not have strict indication and toxic and side effects; 3. adopt oral tablet, easy to use, mouthfeel is good, and the patient easily accepts; 4. medical expense is low, but than conventional therapy cost saving 50--60%, relieve patient ' s burden is easy to promote.

1994--nineteen ninety-five, the inventor has carried out every contrast test with the present invention's " hepatitis B recuperating medicine sheet " with interferon treatment in chronic hepatitis B and has observed, with " hepatitis B recuperating medicine sheet " treatment chronic hepatitis B 120 examples, clinical cure 75 examples, total effective rate is 94.5%, matched group interferon treatment in chronic hepatitis B 120 examples, clinical cure 12 examples, total effective rate is 50%." hepatitis B recuperating medicine sheet " treatment group to the improvement of diseases such as soreness of waist tinnitus, spiritlessness and weakness, inappetence, tongue limit ecchymosis and HBsAg, HBeAg, anti--HBc, DNA--P, HBV-DNA are cloudy changes, anti--the HBe sun changes, transaminase lowering, and improve Archon albumen ratio aspect and all be better than the interferon matched group.Any side effect does not appear in the present invention's " hepatitis B recuperating medicine sheet " therapeutic process, and follow usually in the interferon therapy process low grade fever occurs, tremble, hypotension, feel sick, side reactions such as diarrhoea, myalgia, headache and asthenia.After, doing contrast test with YIGAN SAN, YIGANNING CHONGJI, hepatitis B detoxifying capsule again, the result has shown that the curative effect of medicine of the present invention is all excellent.

Medicine of the present invention example surplus the clinical practice 300, total effective rate 94.5%, HBsAg, HBeAg, anti--HBc, DNA-P, HBV-DNA negative conversion rate are respectively 50%, 70%, 65%, 75%, 74.3%, anti--HBe sun rate of rotation is 70%, obviously is better than domestic and international various hepatitis B medicine.Now lift and test case three for example down:

Li Jinchang, man, 26 years old, the two groups of villagers in Gutian, Xinning County metal and stone town.First visit on June 20 in 1994, suffered from chronic hepatitis B in 1989, through multi-treatment, once used manyzoned polypore gantai, hepatitis spirit, glucuronolatone, interferon etc., heavy when light during the state of an illness, HBsAg does not turn out cloudy all the time, and it is normal that liver function is also recovered, nearly February conscious weak, dizzy, dull pain in liver, after meal abdominal distention, soreness of waist lower limb tired, very easily catch a cold.Health check-up: shallow complexion, lassitude, sclera and skin do not have xanthochromia, the slight distension of abdominal part, 2.5 centimetres below right costal margin of hepatomegaly, the quality medium hardness, tenderness is arranged, kowtow pain, spleen can touch the edge, lower limb slight depression edema, pale tongue has petechia, white and thin fur, stringy pulse is heavy thin and delicate, liver function: icteric index 6 units, Moschus oxalic acid turbidity test 16 units, the oxalic acid flocculation test (+++), glutamate pyruvate transaminase 365 units, albumin 32.4g/L, globulin 34.1g/L, HBsAg, HBeAg, anti--the HBc positive, anti--HBs, anti--the HBe feminine gender, DNA-P, the HBV-DNA positive.Be diagnosed as chronic active hepatitis B, use medicine of the present invention, each 6, boiled water is taken after mixing it with water, day 3 times.The all diseases of further consultation in 4 months of taking medicine are removed to the greatest extent, and liver and spleen retraction is normal, and liver function checks every index and two double inspection full recoveries are normal, follows up a case by regular visits to disease so far and does not recur.

Li Xiufang, woman, 54 years old, peasant, Xinning County Baisha Zhen people.It is surplus to suffer from hepatitis B 1 year, and disease sees that the waist knee joint is aching and tired, spiritlessness and weakness, inappetence, the steady pain in hepatic region, yellowish urine, diarrhea, liver function glutamate pyruvate transaminase 342 units, other are normal, HBsAg (+), HBeAg (+), anti--HBc (+), anti--HBe (-), DNA-P (+), HBV-PNA (+).Take medicine of the present invention further consultation after 6 months, all transference cures, the normal HBsAg of the every index full recovery of liver function test, HBeAg, anti--HBc, DNA-P, HBV-DNA turn out cloudy, and anti--HBe changes sun.Following up a case by regular visits to so far, disease does not recur.

Li Ming, man, 8 years old, Xinning County Wan Tang township Gao Ping people from village.Suffer from hepatitis B in the time of 6 years old, transfer factor, anti-hepatitis B immune ribonucleic acid, YIGANNING CHONGJI and Chinese herbal treatment were once used in the many places treatment, bad during state of an illness fashion, HBsAg, HBeAg, anti--HBc do not turn out cloudy, and disease is seen inappetence, emaciation and sallow complexion, generally very easily catch a cold, obey medicine of the present invention and check the disappearance of all diseases after 5 months, liver function is normal, HBsAg, HBeAg, anti--HBc turn out cloudy, DNA-P, HBV-DNA feminine gender, anti--the HBe positive, disease does not recur so far.

In August, 1996, the present invention's's " hepatitis B recuperating medicine sheet " drug effect is adopted unanimously, and is decided to be the scientific research project Application and Development through province, city, the three grades of expert testimony assessments in county, has been subjected to domestic and international medical circle and patient's popular welcome and praise.News units such as Wen Hui Daily, " Shaoyang daily paper ", Xinning television station have given report.Participate in the outstanding achievement of the international Chinese medicine of U.S.'s first in 1996 and exchange exhibition, obtain outstanding prize of the achievement; In December, 1999 is participated in global Chinese's medical congress, obtains magnificent human relations cup innovation gold medal.This medicine has caused the concern of international medical community.

Embodiment: select for use quality to meet the herbal raw material of Chinese Pharmacopoeia regulation, take by weighing Radix Astragali 900kg, Rhizoma Atractylodis Macrocephalae 450kg, Cordyceps 50kg, Fructus Schisandrae Chinensis 90kg, Hepar Equi stone 900kg, Radix Notoginseng 120kg, Radix Salviae Miltiorrhizae 300kg, Cacumen Securinegae Suffruticosae 180kg, Rhizoma Polygoni Cuspidati 600kg, Herba Turczaninowiae Fastigiatae 900kg, Radix Apioris Fortunei (Radix Lespedezae Buergeri) 450kg, Fructus Amomi 30kg, Ramulus et Folium Phyllodii Pulchelli 450kg, Periostracum Cicadae 300kg by prescription.Earlier Cordyceps, Fructus Schisandrae Chinensis, Radix Notoginseng, Cacumen Securinegae Suffruticosae, Fructus Amomi are pulverized 100 mesh sieves, then the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Hepar Equi stone, Rhizoma Polygoni Cuspidati, Radix Salviae Miltiorrhizae, Radix Apioris Fortunei (Radix Lespedezae Buergeri), Ramulus et Folium Phyllodii Pulchelli, Periostracum Cicadae were ground slightly not the decocting secondary, 4 hours for the first time, 3 hours for the second time, to filter, filtrate is condensed into thick extractum, dry, pulverize 100 mesh sieves, added Cordyceps, Fructus Schisandrae Chinensis, Radix Notoginseng, Cacumen Securinegae Suffruticosae, Fructus Amomi powder, mixing, be pressed into 1000000 in tablet.Pack with bottle, mark medicine name, function cures mainly, and usage and dosages etc. get final product.

Claims

1, a kind of medicine for the treatment of chronic hepatitis B is characterized in that it is the medicament of being made by the following weight proportion raw material.

Radix Astragali 600--900 part Rhizoma Atractylodis Macrocephalae 450---600 part Cordyceps 60--90 part

2, a kind of medicine for the treatment of chronic hepatitis B according to claim 1 is characterized in that the weight proportion of its preferred each raw material is:

3, the medicine of treatment chronic hepatitis B according to claim 1 and 2 is characterized in that this pharmaceutical preparation is ZONGHUI black tablet, tool aromatic odor, the little acid of bitter in the mouth, nontoxic, nonirritant.

4, a kind of medicine for the treatment of chronic hepatitis B according to claim 1 and 2, its preparation is characterised in that:

A, take by weighing each raw material by formula proportion;

B, Cordyceps, Fructus Schisandrae Chinensis, Radix Notoginseng, Cacumen Securinegae Suffruticosae, Fructus Amomi were pulverized 100 mesh sieves;

C, Jiang's Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Hepar Equi stone, Radix Salviae Miltiorrhizae, Rhizoma Polygoni Cuspidati, Herba Turczaninowiae Fastigiatae, Radix Apioris Fortunei (Radix Lespedezae Buergeri), Ramulus et Folium Phyllodii Pulchelli, Periostracum Cicadae grind slightly not, the decocting secondary, 4 hours for the first time, 3 hours for the second time, filter, filtrate is condensed into thick extractum, and drying was pulverized 100 mesh sieves, add Cordyceps, Fructus Schisandrae Chinensis, Cacumen Securinegae Suffruticosae, Radix Notoginseng, Fructus Amomi powder, mixing is suppressed in flakes or is incapsulated.