CN100443093C - AIDS treating medicine - Google Patents
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- CN100443093C CN100443093C CNB2005100109999A CN200510010999A CN100443093C CN 100443093 C CN100443093 C CN 100443093C CN B2005100109999 A CNB2005100109999 A CN B2005100109999A CN 200510010999 A CN200510010999 A CN 200510010999A CN 100443093 C CN100443093 C CN 100443093C
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Abstract
The present invention provides medicine for treating AIDS, namely a compound preparation of a compound SH (siaite) and a preparing method thereof. The compound SH preparation has the functions for inhibiting AIDS viruses, improving the immunity of people, enhancing human immunological functions, and reducing the toxic and side effects of western medicine. The medicine for treating AIDS can make patients and virus infected persons keep a state that viruses are decreased or the viruses are stable so as to prolong the life of AIDS patients. The compound SH can be used for the AIDS patients and AIDS infected persons to prolong the life and to improve the quality of life. The compound SH can be singly used or combined with the western medicine. The compound SH has the advantages of obvious curative effect and no obvious toxic and side effects. Thereby, the present invention is ideal medicine for the AIDS patients, especially patients in third world nations.
Description
[technical field]:
The invention belongs to the field of Chinese medicines, relate to a kind of medicine for the treatment of acquired immune deficiency syndrome (AIDS) and preparation method thereof.
[background technology]:
Acquired immune deficiency syndrome (AIDS) is global difficult disease, claims acquired immune deficiency syndrome (AIDS) again.This disease is mainly destroyed the immune system of human body, makes body lose resistance gradually, and can't resist extraneous various pathogen, and trouble infectious disease or tumor mortality, the patient of whole world infected by HIV has more than 3,000 ten thousand, in state-owned more than 100 ten thousand people, but also with annual 10% speed increment.The main trafficability characteristic of this disease, blood and three kinds of ways of contact of mother and baby are propagated.Infected patient reaches 0.4 thousand ten thousand in World Health Organization's report global ranges in 1992, and nineteen ninety-five, infected patient reached 1.3 thousand ten thousand, and reached 3.0 thousand ten thousand in 1996.Patients infected hiv is counted from initial infection, even reach 10 years or can develop into the acquired immune deficiency syndrome (AIDS) patient after longer incubation period through the several years.Acquired immune deficiency syndrome (AIDS) patient multiple infection can occur because of resistivity extremely descends, as herpes zoster, Fungi Infection of Oral, pulmonary tuberculosis, the enteritis that the specific disease pathogenic microorganism causes, pneumonia, encephalitis etc., malignant tumor usually takes place in the later stage, until consuming because of long-term, whole body dies of exhaustion and dies.Almost high " super cancer " 100% of this case fatality rate listed in the Class B Notifiable disease by China, and is listed in one of border monitoring of hygiene infectious disease.Though whole world national governments, the world of medicine, chemical boundary has all dropped into great amount of manpower, and material resources and financial resources attempt to conquer acquired immune deficiency syndrome (AIDS), do not develop the specific medicament of radical cure acquired immune deficiency syndrome (AIDS) so far as yet, also not can be used for the effective vaccine that prevents.Only accumulated certain experience, known which is the effective ways of virus disseminating of preventing AIDS.And developed some and can effectively suppress the medicine of HIV (human immunodeficiency virus) (Human Immunodeficiency Virus), these medicines can have been alleviated acquired immune deficiency syndrome (AIDS) patient's symptom to a certain extent, prolong patient's life and improve its quality of life.
From first treatment HIV infections/AIDS medicine zidovudine (AZT) in 1987 by after the drugs approved by FDA listing, the research and development of anti-AIDS medicine is advanced by leaps and bounds, external at present existing 16 medicines go on the market.These medicines can only suppress HIV and can not thoroughly kill HIV then, again the patient are produced some side effect simultaneously, and particularly bone marrow depression is a difficult problem that is difficult to overcome, and therefore are badly in need of the inverase that development makes new advances clinically.In addition, these medicament sources are to carry out the screening of anti-HIV from a large amount of synthetic drugs, need cost surprising human and material resources and financial resources.
Chinese herbal medicine is to have possessed the many target spot action and efficacy identical with " HAART ", can antiviral, and again can raise immunity, compare with Western medicine such as AZT, toxic and side effects is little, and it is low toxicity at a low price, easilier accepted, the good social economic benefit is arranged by AIDSinfected patient or HIV sufferers.
Since the Chinese Medicine research worker finds that from the Chinese herbal medicine natural HIV (human immunodeficiency virus)-resistant activity chemical compound of exploitation or guide's thing are treatment or the important channel that prevents AIDS, carried out more work both at home and abroad.By the anti-HIV that comes from the occurring in nature chemical compound is discovered, truly have dissimilar native compounds to show certain HIV (human immunodeficiency virus)-resistant activity at present, the particularly importantly discovery of some guide's things is for scope has been widened in the research of anti-HIV.So far find that more than 100 kind of native compound has certain HIV activity, belongs to sesquiterpene, diterpene, diterpene, steroidal, flavone, coumarin, peptide class, alkaloid, polysaccharide, trichosanthin etc.Find that from Chinese herbal medicine natural HIV (human immunodeficiency virus)-resistant activity chemical compound or guide's thing are importance and the very active fields of studying at present both at home and abroad.Theoretical according to the dialectical treatment of Chinese medicine, use Chinese medicine compound and also obtaining certain success aspect the treatment acquired immune deficiency syndrome (AIDS), as bupleurum root decoction etc.Up to the present still there is not the report that prescription of the present invention is used for the treatment of acquired immune deficiency syndrome (AIDS).
[summary of the invention]:
It is " compound recipe SH " (Siaite) compound preparation that the object of the invention is to provide a kind of medicine for the treatment of acquired immune deficiency syndrome (AIDS).
Another object of the present invention provides the preparation method of this medicine.
Medicine of the present invention selects Cortex Mori, Flos Carthami, Radix Glycyrrhizae to make up.
In order to reach better therapeutic, medicine of the present invention also makes up with the Radix Astragali.
In order to obtain optimum curative effect, medicine of the present invention also can add Herba Artemisiae Scopariae on the said medicine basis.
In addition, the present invention is not precluded within on the above-mentioned five kinds of Chinese medicine prescription basis, and same domain personnel are not taken creative work and added other medical materials of several flavors in addition, also can reach the effect of treatment acquired immune deficiency syndrome (AIDS).
The consumption of drug component of the present invention is groped to sum up to draw through the inventor in a large number, and each amounts of components all has better curative effect in the following weight parts scope:
Cortex Mori 30-90 part, Flos Carthami 1-10 part, Radix Glycyrrhizae 20-50 part
Be preferably: 40-70 part, Flos Carthami 5-10 part, Radix Glycyrrhizae 30-45 part.
More preferably: 60 parts of Cortex Mori, 5 parts on Flos Carthami, 36 parts in Radix Glycyrrhizae.
Each amounts of components of medicine of the present invention can also be Cortex Mori 30-90 part, Flos Carthami 1-10 part, Radix Glycyrrhizae 20-50 part, Radix Astragali 5-15 part.
Be preferably: Cortex Mori 30-90 part, Flos Carthami 1-10 part, Radix Glycyrrhizae 20-50 part, Radix Astragali 8-15 part.
More preferably: 60 parts of Cortex Mori, 5 parts on Flos Carthami, 36 parts in Radix Glycyrrhizae, 6 parts of the Radixs Astragali.
The consumption of each component of medicine of the present invention can also further be Mulberry from skin 30-90 part, Flos Carthami 1-10 part, Radix Glycyrrhizae 20-50 part, Radix Astragali 5-15 part, Herba Artemisiae Scopariae 5-15 part.
Be preferably: Cortex Mori 30-90 part, Flos Carthami 1-10 part, Radix Glycyrrhizae 20-50 part, Radix Astragali 8-15 part, Herba Artemisiae Scopariae 8-10 part.
More preferably: 60 parts of Cortex Mori, 5 parts on Flos Carthami, 36 parts in Radix Glycyrrhizae, 6 parts of the Radixs Astragali, 5 parts of Herba Artemisiae Scopariaes.
The preparation method of medicine of the present invention is, dried Cortex Mori, Radix Glycyrrhizae, the Radix Astragali, further can add Flos Carthami or Flos Carthami and Herba Artemisiae Scopariae, mix by prescription, pulverize, take by weighing the 100g sample and add 70% ethanol, 80 ± 2 ℃ of following heating extraction 4 hours, residue is separated with extracting solution, residue is got extracting solution, merge extractive liquid, with 70% ethanol extraction 2 hours, filtrate is concentrated into no ethanol, add the water defat with petroleum ether, water liquid ethyl acetate extraction is till the acetic acid ethyl fluid paler colour, surplus water liquid discards, reclaim the fluid extract that ethyl acetate partly is relative density 1.2 to 1.4, behind vacuum drying, pulverize and promptly get active constituents of medicine of the present invention, active component is mixed with conventional medicine excipient or additive, make preparation.
The active component of medicine of the present invention can add various conventional adjuvant required when preparing different dosage form, be prepared into any peroral dosage form commonly used as disintegrating agent, lubricant, binding agent etc. with the method for Chinese medicinal of routine, as powder, tablet, granule, capsule etc.
Technical scheme of the present invention is based on that following theory of Chinese medical science proposes.
According to theory of Chinese medical science, traditional Chinese medical science treatment must aim at the pathogenesis of disease, the etiology and pathogenesis of disease originally takes place and forms in what is called exactly.Acquired immune deficiency syndrome (AIDS) is the acquired immunodeficiency syndrome that causes owing to organism infection HIV (human immunodeficiency virus) HIV.HIV invades behind the body or directly destroys the lymphocyte of human body or discharge poisonous substance or combine with non-infected cells, makes its loss of function.After being ill body immune system be in the collapse state, the whole body organ is got involved in succession and a series of opportunistic infections occurred, symptom is intricate, cold and heat are staggered, deficiency and excess is held concurrently mutually, prolongs continuous constantly for very dangerous.Good and evil are constantly resisted in the whole course of disease, just, are that healthy energy is equivalent to body immunity, and heresy is a both virus (comprising HIV) etc. of pathogenic factor.Therefore the rule of having determined the treatment acquired immune deficiency syndrome (AIDS) is a reinforcement and elimination in combination, auxilliary just with uncharm with using.Auxilliary just be enhancing body's immunological function, making it to resist the invasion and attack of virus, uncharming is exactly to kill to drive virus away and make it can not be at body growth.Just can not highly mend but assist, the then positive heat of high benefit is contained and living other disease of change partially.Uncharm and to attack fiercely; HIV sufferers is immunologic hypofunction originally, and onslaught must be hindered healthy energy, and healthy energy is impaired just weak evil strong, and the state of an illness increases the weight of.It is the most key that sense of propriety is held in the compound recipe medication.Cortex Mori not only has stronger HIV (human immunodeficiency virus)-resistant activity among the compound recipe SH (Siaite loose), and the tool classic of TCM to put down in writing its nature and flavor sweet, cold nontoxic, return lung meridian, the lung-heat that can come down in torrents, lowering the adverse-rising QI to subdue asthma has diuretic, the merit of detumescence, expectorant, appetizing, tonify deficiency." herbal classic " " just hinder, the five kinds of over strain six types of severe debility disease is won thinly, collapses the menopause arteries and veins, the tonify deficiency QI invigorating." " not Lu ": " go aqueous vapor in the lung, hemoptysis, heat are thirsty, and the edema abdominal distention is set out bloated, and dredging water passages goes cun whitely, can stitch incised wound." " property of medicine opinion ": control the lung qi dyspnea with fullness of the chest, the aqueous vapor edema, the main wound cut off, dredging water passages, the headache of the aqueous vapor that disappears asthenia exopathogenic heat, interior tonifying for the deficiency." " big bright book on Chinese herbal medicine ": " and the therapeutic method to keep the adverse QI flowing downwards in the accent, expectorant is quenched the thirst, and whetting the appetite kills the alvus worm, ends the cholera vomiting and diarrhoea." now study and cognition is very complicated to the clinical symptoms of acquired immune deficiency syndrome (AIDS), people's respiratory system, digestive system, urinary system, cardiovascular system and eye, skin etc. are all come to harm and produce pathological changes.Wherein especially with the pulmonary lesion incidence rate for the highest, it is maximum to reach the 70-80.8% pneumocystis carinii pneumonia, become the most common and the most serious opportunistic infection of acquired immune deficiency syndrome (AIDS), also have pulmonary infection that pulmonary tuberculosis and other opportunistic infection cause and Ka Boxidai sarcoma in addition to the infringement of pulmonary etc.
The present invention is based on following know-why and formulates out:
Chinese medicine of the five flavours Cortex Mori, Flos Carthami, Herba Artemisiae Scopariae, Radix Glycyrrhizae, the Radix Astragali all are avirulent traditional medical materials in the Siaite (SH), they meet statutory standards, China is domestic had on century-old use history, according to Chinese medical theory, combination principle by " monarch, minister, help, make ", the extract of different solvents to this five tastes medical material, and the effective site reasonable formula that obtains, Siaite (SH) preparation made.Said preparation does not have eighteen incompatible medicaments, and incompatibilitys such as nineteen medicaments of mutual restraint are again without chemical treatment (except the water, the thick extraction of alcohol).Full side is a monarch drug with the Cortex Mori, and Cortex Mori can go to kill the virus and can control many symptoms of pulmonary infection, and hold concurrently can diuretic, detumescence, appetizing, tonify deficiency, do not hinder healthy energy thus be that monarch drug is the most appropriate." " the nature and flavor hardship, it is nontoxic to be slightly cold, and returns spleen, stomach, liver, gallbladder meridian for the mattress skin.Clearing away heat-damp and promoting diuresis is arranged, and function of gallbladder promoting goes the effect of Huang." herbal classic ": " the raw pathogen of main air, the yellow disease of accumulation of heat." " not Lu ": " the whole body jaundice, dysuria remove feverish sensation in the head." " big bright book on Chinese herbal medicine ": control disease when day capable, fanatic headache, painful, the miasma scrofula of whirlwind eye "." in the inner feelings ginseng west record ": " heat of kind all liver and gall, the reason of holding concurrently liver and gall strongly fragrant, heat strongly fragrant the opening that disappear, the road of bile such as small intestinal is also unseparated." modern pharmacological research thinks that the Herba Artemisiae Scopariae decoct has complete inhibitory action to the Bacillus tuberculosis, bacillus subtilis, Bacillus typhi, staphylococcus aureus, pathogenicity filamentous bacteria and some dermatophytes there are certain inhibitory action, and also have significant choleretic effect." Flos Carthami " nature and flavor suffering, tepor is nontoxic, returns liver, heart channel, and the effect that has promoting blood circulation to restore menstrual flow, blood stasis removing to relieve the pain, dissipate is widely used blood circulation and promoting silt medicine." Kaibao Bencao ": " in the bruise behind the main product, locked mouth, abdomen stagnant blood not to the utmost, angor, retention of dead fetus, and wine boils the malicious hematochezia of the also main handleless cup of clothes." Compendium of Material Medica: " invigorate blood circulation and moisturize, pain relieving, swollen the stimulating the menstrual flow of loosing." above two kinds be all ministerial drug, play the effect that auxiliary monarch drug is strengthened the monarch drug effect." Radix Astragali " nature and flavor are sweet, and tepor is nontoxic, return the spleen lung meridian, and tonifying Qi and lifting yang is arranged, strengthening superficial resistance to stop perspiration, the effect of Tuoli granulation promoting, diuretic detumescent." herbal classic ": " main pain loses skin ulcer, evacuation of pus pain relieving, strong wind leprosy disease, five hemorrhoid scrofula, tonify deficiency, children's's all kinds of diseases and ailments for a long time." " not Lu " " control the dirty ailment said due to cold or exposure gas of married woman's, by stagnant blood between the five internal organs, it be deficient to mend the husband, and five kinds of over strain is won thin, quenches the thirst, suffers from abdominal pain and let out dysentery, QI invigorating, sharp yang-energy." " property of medicine opinion ": control carbuncle on the back, interior benefit is controlled dyspnea due to deficiency, renal failure, deafness is treated cold and heat." this can strengthen the merit of principal agent tonify deficiency QI invigorating for adjuvant drug, agitates that poison is evil discharges, what can restrict again that lung qi falls in principal agent very reaches hardship, cold property." the Radix Glycyrrhizae nature and flavor are sweet flat nontoxic, GUIXIN, lung, spleen, stomach warp.Invigorating the spleen and replenishing QI is arranged, heat-clearing and toxic substances removing, nourishing the lung to arrest cough, the effect of relieving spasm to stop pain, the mitigation property of medicine." herbal classic ": warming the middle warmer and descending qi, stuffy sensation with restlessness is losed heart, and impairing the lung cough is quenched the thirst, qualcomm meridian, sharp vim and vigour, separates hundred poison of drug.Therefore be messenger drug, coordinating the actions of various ingredients in a prescription, each herbal medicine effect complements each other in the side of making, and brings out the best in each other, and can strengthen the auxilliary merit just of primary and secondary prescription, the power of detoxifcation, in general: the mutual compatibility of above five tastes medicine, monarch, minister, help, make and make a distinction between the important and the lesser one, mend and oiliness, attack and do not hinder, among the tonification involving purgation, be a comparatively ideal prescription.
From modern medicine and pharmacology's principle, compare with the Western medicine of present treatment acquired immune deficiency syndrome (AIDS) or Chinese medicine and preparation thereof, the effect of the existing inhibition HIV (human immunodeficiency virus) (Human Immunodeficiency Virus) of " compound recipe SH " preparation can improve people's immunity again, improve immunologic function, and can reduce the toxic and side effects of Western medicine.This is we's characteristic place, also embodies the also effect of Chinese medicine compound wholistic therapy, multipath, the adjusting of many target spots.
" compound recipe SH " preparation is by three flavor Chinese prescriptions, so with this this be synthetic four flavors of base set or the five tastes or more the kinds of traditional Chinese medicines prescription make, remarkable to treating HIV sufferers and AIDSinfected patient clinical effectiveness." compound recipe SH " can effectively kill HIV (human immunodeficiency virus) (Human Immunodeficiency Virus), and virus load is obviously descended, and can also improve T-4 (immunocyte) cytoactive simultaneously, strengthens the human body body immunity.This shows: use " compound recipe SH " Drug therapy can make patient and viral infection person keep virus to descend or steady statue, thereby prolong acquired immune deficiency syndrome (AIDS) patient's life! " compound recipe SH " can be used for the acquired immune deficiency syndrome (AIDS) patient, also can be used for AIDSinfected patient, and prolongation life is also improved the quality of living.Can use separately, also can share with Western medicine.The advantage of " compound recipe SH " is evident in efficacy, does not have obvious toxic-side effects, is especially third world countries patient's ideal medicament of vast HIV sufferers.
[specific embodiment]:
Below further sets forth the beneficial effect of medicine of the present invention by testing example, these test examples have comprised with the pharmacological toxicology that the present invention's three flavors and even four are distinguished the flavor of, the five kinds of Chinese medicine compound recipe is example to be tested and clinical observation on the therapeutic effect is tested.
[test example 1]: pharmacological toxicology test of the present invention
1. pharmacological toxicology testing data
1.1 pharmacodynamic study data
On the basis of Chinese herbal treatment acquired immune deficiency syndrome (AIDS), three kinds of Cortex Mori, Flos Carthami, Radix Glycyrrhizae have been selected, add that further the Radix Astragali or the Radix Astragali, Herba Artemisiae Scopariae have obvious inhibiting Chinese herbal medicine to HIV for five kinds and form compound recipe SH, utilize the MTT method to measure Cortex Mori, Flos Carthami, Radix Glycyrrhizae in external inhibitory action to HIV, the medium effective concentration of finding them is that EC50 is respectively: 14.3,0.628,44.4 μ g/ml, 428,＞250,89.1 μ g/ml the half toxic concentration is that IC50 is respectively:, its therapeutic index is respectively 30.0,＞398,2.01.The result shows that planting Chinese herbal medicine here has the effect of good in vitro HIV (human immunodeficiency virus)-resistant activity.Simultaneously the effective site of five kinds of Chinese herbal medicine has been carried out external HIV (human immunodeficiency virus)-resistant activity research, the result shows that Cortex Mori, Flos Carthami, Radix Glycyrrhizae are respectively the EC50 of HIV: 14.3,62.8,10.1 μ g/ml, IC50 is respectively 428,＞250,＞250 μ g/ml, then therapeutic index is respectively: 30,＞39.8,＞24.8; The extract of the Radix Astragali and Herba Artemisiae Scopariae inhibitory action to HIV when concentration is 0.5mg/ml all reaches more than 95%.In addition wherein reactive compound has been carried out external HIV (human immunodeficiency virus)-resistant activity screening, found that also reactive compound really can good restraining HIV virus among the compound recipe SH.These results show that the component part of compound recipe SH is in external activity with anti HIV-1 virus.The compound recipe SH of these three kinds to five kinds Chinese herbal medicine compositions shows in external HIV (human immunodeficiency virus)-resistant activity result of experiment: this compound recipe shows good HIV (human immunodeficiency virus)-resistant activity in the concentration range of 83-167 μ g/ml.
1.2 acute toxicity test
Siaite (SH) acute toxicity test is more than 200 times, to give 20 mouse stomach administrations at clinical dosage, observes continuously in 7 days, do not see that obvious toxic reaction appears in animal, all animals survival, activity is freely, feed drinking-water and defecation are all normal, and the body weight normal growth is all right.
1.3 long term toxicity test
Siaite looses (compound recipe SH) with 6.4g/kg/day, 3.2g/kg/day, 1.6g/kg/day three dosage groups (40/group), be equivalent to 51.2 times of clinical recommendation adult's dosage (125mg/kg/day), 25.6 doubly reach 12.8 times, irritate stomach respectively and give rat, continuous 26 weeks, compare (40/group) with normal saline, recovered for 4 weeks after the drug withdrawal.Observe behavioral activity, outward appearance sign, diet, feces, the body weight of animal during the administration.All no abnormal during the administration.Finish administration mid-term, latter stage and drug withdrawal convalescent period, respectively to 5 indexs of hematology (leukocyte and classification, erythrocyte, platelet, hemoglobin, reticulocyte) blood biochemical 16 indexs (alanine aminotransferase, aspartic transaminase, alkali phosphatase, blood urea nitrogen, creatinine, glucose, total bilirubin, T-CHOL, total protein, albumin, triglyceride, creatine phosphokinase, gamma glutamyltransferase, Na
+, K
+, Cl
-) detect, obduction observes, weigh and calculate separately organ coefficient in brain, the heart, liver, spleen, lung, kidney, adrenal gland, thymus, ovary, testis, uterus.Histopathologic examination: core, liver, spleen, lung, kidney, adrenal gland, brain, hypophysis cerebri, stomach, thymus, spinal cord (neck, breast, waist section), duodenum, ileum, colon, prostate, brain, hypophysis cerebri, eyeball (optic nerve), trachea, thyroid, testis, epididymis, uterus, ovary, bladder, breastbone (and bone marrow), lymph node, all animals carries out the histopathologic examination of above each internal organs.More than detecting the index result all belongs to normally.Diffusing clinical adult's dosage 125mg/kg/day is safer for the prompting Siaite.
The clinical observation of [test example 2] Drug therapy acquired immune deficiency syndrome (AIDS) of the present invention
1, clinical research testing data
Material and method:
Object of study: select HIV the infected, and the men and women respectively accounts for certain ratio, the age must be lawful age above (promptly selecting the age the men and women HIV the infected between 20-50 year); No congenital, day after tomorrow and iatrogenic immune deficiency and tumor history.
Diagnostic criteria: 1, HIV antibody positive, and virus load is 20,000-100,000,2, CD4+ lymphocyte 〉=200cells/mL, 3, do not have other any ill symptomses, 4, do not take any other inverase.
Research method:
Case grouping: adopt the method for random packet, use compound recipe SH to organize 28 examples separately, AZT+DDC+ compound recipe SH organize (40/44 example), and AZT+DDC+ placebo group (20/38 example) is excluded the 22 routine patients in addition outside clinical simultaneously.This research has obtained adopting unanimously of Thailand Ministry of Public Health study of ethics committee.
The patient of Pass Test condition is divided into three groups at random, and both A group, B group and C organized, and A group patient takes Siaite (SH) 2.5g, one day three times every day at every turn; B group patient takes AZT 200mg every day, DDC0.75mg, Siaite (SH) 2.5g, one day three times at every turn; C group patient takes AZT200mg every day, DDC0.75mg, placebo 2.5g, one day three times at every turn.
The patient who meets experimental standard will accept interview and health check-up, comprises botal blood volume, urine examination, hematuria element, early pregnancy test (female patients), blood sugar level on an empty stomach, P-amylase, cholesterol, triglyceride, whole protein, albumin, uric acid, sodium, potassium and chloride, Chest X-rays, HIV virus load, CD4 counting etc.
Patient must accept Clinical detection after 4,8,12,16,20 and 24 weeks of taking medicine, if they are unwilling to participate in again or other clinical project is arranged and do not want continue to participate in and clinically can inform the person in charge.Whole clinical during, all will write down and detect patient's case history, health check-up, urinalysis and early pregnancy inspection.The laboratory blood examination comprises HIV-RNA, cd4 cell, and CBC, FBS, BUN, uric acid, electrolyte, SGPT, bilirubin, globulin contains the alkali phosphatase, and amylase after six months, is carrying out the Chest X-rays of an X-light.
2, therapeutic outcome:
(1) takes compound recipe SH group (28 example) separately
A has 9 routine HIV the infected's virus loads obviously descend (more than 0.5 log) (32.14%)
B16 example HIV the infected virus load do not change (57.14%)
C3 example HIV the infected's virus load rising (10.72%)
Be that obvious effective rate is 32%, total effective rate reaches 89.28%
As can be seen from Table 1: the SH medicine can obviously reduce patient's virus load.
As can be seen from Table 2: cd4 cell is rising always, and 12 all cd4 cells and 0 week compare, the nearly 100cells/ml that risen, and patient's immunologic function is strengthening.
As can be seen from Table 3: after taking compound recipe SH, some patient can show slight side effect, but all not serious, have within normal range, the toxic and side effects that compound recipe SH is described is lower.
In sum, the SH medicine reveals gratifying result to the control table of HIV-1 virus load, has improved clinical symptoms, has reduced patient's opportunistic infection.
(2) take AZT+DDC+SH group and AZT+DDC+ placebo group (60/82 example)
The variation of A, two groups of test patients HIV-RNA (60 example)
From table 4-6 as can be seen: two groups of clinical trial patients whole clinical during virus load (HIV-RNA) not significantly different (p=0.45), two groups of clinical trial patients HIV-RNA are with baseline value significantly decrease (p＜0.001) after 4 weeks, patient's virus of Siaite (SH) group descend than fast many (p＜0.001) in placebo group, in 20-24 week, the shared percentage ratio of the patient of 1-2 the order of magnitude of SH papova decline will be far away more than in placebo group, and also have 3 routine patients to detect less than HIV-RNA in the 24th week in Siaite (SH) group, but in placebo group this situation does not appear.
The situation of change of B, two groups of test patients cd4 cells (60 example):
Two groups of clinical trial patients are 0,4,8,12, the logarithmic deviation of 16,20 and 24 all cd4 cells sees Table 7, two groups of clinical trial patients's cd4 cells not significantly different (p=0.21), after 12 weeks, with baseline value tangible rising (p＜0.05) is arranged relatively, but placebo group cd4 cell in whole 24 weeks there is not obvious variation at Siaite (SH) group clinical trial patients cd4 cell.
The hematology and the biochemical analysis of C, AZT+DDC+SH group and AZT+DDC+ placebo group
Except that the symptom that gastrointestinal upset is arranged of early stage description, in the experimental period in whole 24 weeks, two groups of patients' biochemical indicator does not have obvious variation, comprises hemocyte, urine, blood glucose, renal function, electrolyte, (seeing Table 8) such as phosphorous alkaloid and albumin.
D, drop by the wayside patient's analysis (22 example):
The patient who participates in the drug combination group has 82 examples, wherein the SH group has 44 examples, placebo group has 38 examples, but only has 60 people that the clinical data data are arranged in the 12nd week back AZT+DDC+SH group and AZT+DDC+ placebo group, has in the middle of this 60 people that 40 people organize at SH, 20 people are in placebo group.Be excluded 22 people that have outside clinical trial.This 22 philtrum has 10 people to run off, with clinical hospital (wherein 2 people SH group, 8 people in placebo group) out of touch, other has 12 people, and (2 people organize at SH to drug allergy, 10 people are in placebo group), these irritated patients' clinical symptoms is that anorexia, vomiting, abdominal part are uncomfortable, these patients that do not have to take placebo among the patient of data infer that far away more than the patient who takes the SH medicine SH medicine can alleviate patient's toxic and side effects, increase its curative effect.Be that these data show substantially: the SH medicine has the effect of attenuation synergistic.This shows that the SH medicine can alleviate patient's toxic and side effects, increase its curative effect.
3, conclusion
3-1, compound recipe SH are by three kinds of Cortex Mori, Flos Carthami, Radix Glycyrrhizae, can further add the extract of the Radix Astragali or the Radix Astragali and five kinds of traditional medical materials of Herba Artemisiae Scopariae and the effective site composition that obtains through organic solvent extraction, can suppress or kill HIV virus, can strengthen immune function of human body by strengthening the body resistance again.
3-2, compound recipe SH prescription is that pharmacopeia is recorded traditional medical material effective site composition, and the prescription medication does not have eighteen incompatible medicaments, and nineteen medicaments of mutual restraint is observed by clinical 110 routine clinical patients, shows that compound recipe SH has good therapeutic effect to HIV-the infected, and not seeing has obvious toxic and side effects.The group of taking medicine separately (28 example) clinical effectiveness shows 9 routine HIV the infected's virus loads obviously descend (accounting for 32.14%); 16 routine HIV the infected's virus loads do not change (accounting for 57.14%); 3 routine HIV the infected's virus loads raise (accounting for 10.72%), and promptly obvious effective rate is 32%, and total effective rate reaches 89%, and patient's cd4 cell is raising always, and immunologic function is strengthening.Show with two groups of patients' of Western medicine drug combination (60 example) clinical effectiveness: (1) HIV-RNA situation of change: two groups of clinical trial patients HIV-RNA are with baseline value significantly decrease (p＜0.001) after 4 weeks, in patient's virus decrease speed of Siaite (SH) group than fast many (p＜0.001) in placebo group, in 20-24 week, to be far longer than in placebo group at the shared percentage ratio of patient of 1-2 the order of magnitude of SH papova decline.And also have 3 routine patients to detect less than HIV-RNA in the 24th week in Siaite (SH) group, but in placebo group this situation does not appear.(2) cd4 cell situation of change: after 12 weeks, with baseline value tangible rising (p＜0.05) is arranged relatively, but do not have obvious variation at placebo group cd4 cell in whole 24 weeks at Siaite (SH) group clinical trial patients cd4 cell.Drop by the wayside patient's analysis (22 example): be excluded 22 people that have outside clinical trial.This 22 philtrum has 10 people to run off, with clinical hospital (wherein 2 people SH group, 8 people in placebo group) out of touch, other has 12 people, and (2 people organize at SH to drug allergy, 10 people are in placebo group), these irritated patients' clinical symptoms is that anorexia, vomiting, abdominal part are uncomfortable, these patients that do not have to take placebo among the patient of data are far away more than the patient who takes the SH medicine, and these data show substantially: the SH medicine has the effect of attenuation synergistic.Side effect is analyzed: except that the symptom that gastrointestinal upset is arranged of early stage description, in the experimental period in whole 24 weeks, several groups of patients' biochemical indicator does not have obvious variation, comprises hemocyte, urine, blood glucose, renal function, electrolyte, phosphorous alkaloid and albumin etc.Show that the SH medicine does not have obvious toxic and side effects.
3-3, pharmacodynamic experiment show: compound recipe SH energy Profilin hydrolytic enzyme, and can strengthen NKT power cytoactive, thus have immunoregulation capability.
3-44, acute toxicity test show that compound recipe SH is nontoxic, do not draw LD
50, toxicity test animal ordinary circumstance, hematology, biochemical indicator show no obvious abnormalities variation.
3-5, compound recipe SH both can take separately, also can share with anti-HIV Western medicine, both applicable to HIV the infected, also applicable to the acquired immune deficiency syndrome (AIDS) patient.
Five kinds of medical materials of 3-6, composition compound recipe SH have extensive plantation in China, aboundresources, and preparation technology is simple for this dosage form, with respect to other anti-HIV Western medicine, low price, the numerous HIV the infected or the HIV sufferers of suitable China and other third world countries,
3-7, compound recipe SH clinical trial method adopt double-blind method, and the strictness of clinical patient screening criteria obtains international medical and health circle approval easily.
Table 1: the variation of patient multiplexing separately " SH " back 0,4,8,12 all viral HIV-RNA
| ＜400 | 400-1000 | 1000-10000 | ＞10000 | |
| 0 week | 0 | 0 | 0 | 100％ |
| 4 weeks | 18.75％ | 15.60％ | 45.30％ | 20.30％ |
| 8 weeks | 17.30％ | 13.50％ | 44.20％ | 25％ |
| 12 weeks | 27.10％ | 12.50％ | 41.70％ | 18.80％ |
Table 2: the variation of patient multiplexing separately " SH " back 0,4,8,12 all cd4 cells
Table 3: the back side effect situation of taking medicine behind the patient multiplexing separately " SH "
Table 3: the back side effect situation (continuing) of taking medicine behind the patient multiplexing separately " SH "
Table 4: Siaite (SH) group and two groups of patients' of placebo group HIV-1RNA value (log)
| Time | Siaite (SH) group | Placebo group |
| 0 week (N=60) | 4.69±0.44(N＝40) | 4.79±0.54(N＝20) |
| 4 weeks (N=60) | 2.93±0.76(N＝40) | 3.81±0.77(N＝20) |
| 8 weeks (N=60) | 2.93±0.78(N＝40) | 4.18±0.57(N＝20) |
| 12 weeks (N=60) | 2.90±0.63(N＝40) | 4.12±0.60(N＝20) |
| 16 weeks (N=59) | 2.80±0.67(N＝39) | 4.30±0.64(N＝20) |
| 20 weeks (N=58) | 2.76±0.69(N＝39) | 4.18±0.77(N＝19) |
| 24 weeks (N=35) | 2.65±0.72(N＝24) | 4.15±0.89(N＝11) |
● there is a research center to forget about bringing all patients' blood sample, has only partly data here when therefore surveying
Table 5: two groups of patients take medicine 20 week its HIV-1RNA value decline situations (log) of back
| The HIV-RNA drop-out value | Siaite (SH) group | Placebo group | The p-value |
| ≥1.0log | 35(89.7％) | 5(26.3％) | ＜0.001 |
| ≥1.5log | 29(74.4％) | 2(10.5％) | ＜0.001 |
| ≥2.0log | 16(41.0％) | 2(10.5％) | 0.04 |
Table 6: two groups of patients take medicine 24 week its HIV-RNA value decline situations of back
| The HIV-RNA drop-out value | Siaite (SH) group | Placebo group | The p-value |
| ≥1.0log | 24(100％) | 4(36.4％) | ＜0.001 |
| ≥1.5log | 17(70.8％) | 2(18.2％) | 0.01 |
| ≥2.0log | 13(54.2％) | 1(9.1％) | 0.02 |
Table 7: 0,4,8,12,16,20,24 its cd4 cell situations of change of all backs that Siaite (SH) is organized and two groups of patients of placebo group take medicine
| Time | Siaite (SH) group | Placebo group |
| 0 week (N=60) | 364±174(N＝40) | 430±229(N＝20) |
| 4 weeks (N=60) | 378±182(N＝40) | 403±211(N＝20) |
| 8 weeks (N=60) | 365±156(N＝40) | 419±246(N＝20) |
| 12 weeks (N=60) | 444±163(N＝40) | 483±240(N＝20) |
| 16 weeks (N=59) | 452±213(N＝39) | 429±234(N＝20) |
| 20 weeks (N=58) | 463±202(N＝39) | 429±234(N＝19) |
| 24 weeks (N=37) | 424±187(N＝24) | 394±189(N＝13) |
● there is a center to forget about bringing all this center patients' blood sample
Table 8: to the baseline characteristic analysis of effective case
| The mensuration project | Siaite (SH) group (N=40) | Placebo group (N=20) | The p-value |
| M-F-man: woman | 7:33 (man=17.5%) | 4:16 (man=20%) | 1 |
| Age bracket | 23-57 | 23-48 | |
| Mean age | 35.6±8.2 | 31.9±8.1 | 0.1 |
| Average weight (Kg) | 52.6±9.5 | 51.4±7.1 | 0.6 |
| Heterosexuel | 38/39(97.4％) | 18/19(94.7％) | 1 |
| IVDU | 1/39(2.6％) | 1/19(5.2％) | 1 |
| KPS＝100 | 37(92.5％) | 20(100％) | 1 |
| Average virus load (log) | 4.69±0.44 | 4.79±0.54 | 0.45 |
| Average virus load (copy) | 81590±97786 | 113513±124352 | 0.43 |
| Meansigma methods | 42250 | 89650 | |
| Scope | 6500-488000 | 8650-518000 | |
| CD4 | 364±174 | 430±229 | 0.21 |
| The CD4 scope | 103-883 | 64-1025 | |
| Hb(gm％) | 12.3±1.9 | 11.9±1.5 | 0.37 |
| Leukocyte | 6302±1757 | 6910±2476 | 0.29 |
| Platelet (* 10 3) | 240.2±64.7 | 239.3±64.8 | 0.96 |
| FBS | 95±48 | 78±29 | 0.13 |
| BUN | 10±3 | 10±2 | 0.99 |
| Creatine | 0.8±0.2 | 0.8±0.2 | 0.49 |
| Albumin | 4.6±0.4 | 4.5±0.5 | 0.5 |
| SGOT | 34±24 | 38±48 | 0.69 |
| SGPT | 47±51 | 37±29 | 0.41 |
| Alkaline phospholipase | 82±32 | 88±40 | 0.57 |
| Na + | 141±3 | 142±4 | 0.11 |
| K + | 3.9±0.4 | 3.8±0.3 | 0.62 |
| Cl - | 104±3 | 105±2 | 0.68 |
| HCO 3 - | 22.9±3.1 | 22.6±3.1 | 0.68 |
Come further to set forth the preparation method of medicine of the present invention by the following examples.
The active component preparation of [embodiment 1] medicine of the present invention
Get Cortex Mori 30Kg, Radix Glycyrrhizae 18Kg, Radix Astragali 3Kg, dried Cortex Mori, Radix Glycyrrhizae, the Radix Astragali is pulverized, and further can add Flos Carthami 2.5Kg, or Herba Artemisiae Scopariae 2.5Kg and Flos Carthami 2.5Kg, pulverize, mix, add 70% ethanol, 80 ± 2 ℃ of following heating extraction 4 hours, residue is separated with extracting solution, residue is got extracting solution, merge extractive liquid, with 70% ethanol extraction 2 hours, filtrate is concentrated into no ethanol, add the water defat with petroleum ether, water liquid ethyl acetate extraction is till the acetic acid ethyl fluid paler colour, surplus water liquid discards, reclaim the fluid extract that ethyl acetate partly is relative density 1.2 to 1.4, behind vacuum drying, pulverize and promptly get 2.8 kilograms of active constituents of medicine of the present invention.
The powder preparation of [embodiment 2] medicine of the present invention
The active constituents of medicine that embodiment 1 is obtained is ground into powder, and every 2.5Kg medicated powder adds starch 0.4kg, Pulvis Talci 0.1kg and mixes, and porphyrize is crossed sieve No. 6, and the product inspection warehousing after passing gets final product.
The capsule preparation of [embodiment 3] medicine of the present invention
The active constituents of medicine that embodiment 1 is obtained is ground into powder, adds corresponding auxiliary material, the snap fit capsule of packing into.
The granule preparation of [embodiment 4] medicine of the present invention
With embodiment 1 gained active constituents of medicine mix homogeneously of the present invention, be ground into fine powder again, add ethanol and make adhesive, add starch and make filler, be pressed into granule.
The preparation tablets of [embodiment 5] medicine of the present invention
With embodiment 1 gained active constituents of medicine mix homogeneously of the present invention, be ground into fine powder, add adjuvant and make granule, and dry, spray into Herba Asari volatile oil, compacting is in flakes.
Claims (4)
1, a kind of medicine for the treatment of acquired immune deficiency syndrome (AIDS) is characterized in that it mainly is to be made by following bulk drugs: Cortex Mori 30-90 part, Flos Carthami 1-10 part, Radix Glycyrrhizae 20-50 part.
2, according to the medicine of claim 1, wherein the weight proportion of each crude drug is: Cortex Mori 40-70 part, Flos Carthami 5-10 part, Radix Glycyrrhizae 30-45 part.
3, medicine according to claim 1 and 2, wherein the weight proportion of crude drug is: 60 parts of Cortex Mori, 5 parts on Flos Carthami, 36 parts in Radix Glycyrrhizae.
4, according to the described medicine of claim 1, wherein crude drug also has: Radix Astragali 5-15 part.
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