WO2011113190A1 - Composition pharmaceutique pour le traitement du sida, et procédé de préparation associé - Google Patents

Composition pharmaceutique pour le traitement du sida, et procédé de préparation associé Download PDF

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WO2011113190A1
WO2011113190A1 PCT/CN2010/001968 CN2010001968W WO2011113190A1 WO 2011113190 A1 WO2011113190 A1 WO 2011113190A1 CN 2010001968 W CN2010001968 W CN 2010001968W WO 2011113190 A1 WO2011113190 A1 WO 2011113190A1
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parts
solution
chinese medicine
traditional chinese
medicine composition
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段荣书
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段颖哲
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A61P31/18—Antivirals for RNA viruses for HIV
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Definitions

  • the invention relates to a traditional Chinese medicine composition, in particular to a traditional Chinese medicine composition for treating AIDS, belonging to the field of traditional Chinese medicine. Background technique
  • AIDS is a contagious disease that seriously threatens people's health. Its mortality rate is extremely high. At present, there is no effective vaccine prevention and no cure. It spreads widely and is popular, which not only causes huge economic losses, but also Mission hindering social development has become a social issue of great concern to governments. As China's Ministry of Health, the State Planning Commission, the Ministry of Science and Technology, and the Ministry of Finance jointly formulated the "China Medium- and Long-Term Plan for Prevention and Control of AIDS" (1998-2010): "Prevention and control of AIDS is an urgent, complex and long-term arduous task.
  • HAART can be up to 70% after 4 to 5 years of clinical application, and most patients have greater toxic side effects, resulting in decreased patient compliance, 25% of patients will stop HAART; (3) Limitations of indications: For HIV-infected patients with CD4+T cells >400/ ⁇ 1 and plasma HIVRNA ⁇ 30000, antiviral therapy is not advocated, while untreated patients have a >30% chance of developing AIDS within 3 years; (4) Expensive : Patients with HAART need about 800,000 yuan to 100,000 yuan per year. Currently, they can receive HAART patients at their own expense, with only 400 to 500 people per year. The vast majority of poor AIDS patients in China are in a state of no drug availability.
  • HAART treatment requires lifelong medication, for the purpose of shortening the medication time, the treatment is mostly initiated in the middle and late stages of infection.
  • the immunodeficiency caused by HIV infection is a process of chronic progress of interaction between HIV virus and immune system. In the medium term, progressive destruction of immune tissues occurs. If the immune regulation can be treated in time to protect the infected person's immune system, it may delay the time of HAART treatment and play a good therapeutic role. Therefore, the search for safe and effective immune function, while anti-viral natural drugs have become an important research direction in the prevention and treatment of AIDS. Summary of the invention
  • An object of the present invention is to provide a traditional Chinese medicine composition for treating AIDS, and to provide a preparation method of the traditional Chinese medicine composition and a method for detecting the active ingredient thereof.
  • the object of the present invention is achieved by the following technical solutions.
  • the traditional Chinese medicine composition for treating AIDS according to the present invention is prepared from the following raw materials by weight:
  • the traditional Chinese medicine composition for treating AIDS according to the present invention is preferably made of the following raw materials by weight: 40 to 45 parts of velvet antler, 130 to 150 parts of Epimedium, 130 to 150 parts of Astragalus, 130 to 150 Cnidium 150 copies, Hawthorn
  • the traditional Chinese medicine composition for treating AIDS according to the present invention is more preferably made of the following raw materials by weight: 42 parts of antler, 140 parts of Epimedium, 140 parts of Astragalus, 140 parts of Cnidium, 140 parts of Hawthorn, 280 parts of Rehmannia glutinosa.
  • the traditional Chinese medicine composition for treating AIDS according to the present invention is prepared from the following raw materials by weight:
  • the traditional Chinese medicine composition for treating AIDS according to the present invention is preferably made of the following raw materials by weight: 40 to 45 parts of velvet antler, 130 to 150 parts of Epimedium, 130 to 150 parts of Astragalus, 130 to 150 Cnidium 150 copies, Hawthorn
  • the traditional Chinese medicine composition for treating AIDS according to the present invention is more preferably made of the following raw materials by weight: 42 parts of antler, 140 parts of Epimedium, 140 parts of Astragalus, 140 parts of Cnidium, 140 parts of Hawthorn, 280 parts of Rehmannia glutinosa, 140 parts of Curculigo, 140 parts of nutmeg, 140 parts of yam.
  • the traditional Chinese medicine composition for treating AIDS according to the present invention is prepared from the following raw materials by weight:
  • the traditional Chinese medicine composition for treating AIDS according to the present invention is preferably made of the following raw materials by weight: 40 to 45 parts of velvet antler, 130 to 150 parts of Epimedium, 130 to 150 parts of Astragalus, 130 to 150 Cnidium 150 copies, Hawthorn
  • the traditional Chinese medicine composition for treating AIDS according to the present invention is more preferably made of the following raw materials by weight: 42 parts of antler, 140 parts of Epimedium, 140 parts of Astragalus, 140 parts of Cnidium, 140 parts of Hawthorn, 280 parts of Rehmannia glutinosa, 140 parts of Curculigo, 1 ⁇ part of nutmeg, 140 parts of yam, 140 parts of medlar, 140 parts of Cistanche, and 70 parts of psoralen.
  • the raw materials mentioned above are all Chinese herbal medicines or their processed products.
  • the specific sources are:
  • Luhan For the deer sika deer Cervus nippon Temminck or red deer Cervus elaphus Linnaeus stag The young horns of the ossified hairs.
  • Epimedium Epimedium brevicornum Maxim., Epimedium sagittatum (Sieb. et Zucc.) Maxim. > Epimedium pubescens Maxim., Epimedium wushanense The dry ground part of TS Ying, or Epimedium koreanum Nakai.
  • Cnidium A dry mature fruit of the genus Cnidium monnieri (L.) Cuss.
  • Hawthorn Dry ripe flesh of Cornus officinalis Sieb. et Zucc.
  • Rehmannia glutinosa A freshly processed or dried root of Rehmannia glutinosa Libosch., processed in accordance with the "wine stewing method” or “steaming method” in the Chinese medicine processing method.
  • Curculigo The dried rhizome of the Amaryllidaceae Curculigo orchioides Gaertn.
  • Nutmeg Dried kernels of the nutmeg Myristica fragrans Houtt., used after tanning. .
  • Hazelnut It is a dry ripe fruit of the Solanaceae plant Lycium barbarum L.
  • Cistanche A dried, scaly fleshy stem of the Cistanche deserticola Y. C. Ma or Cistanche tubulosa (Schrenk) Wight.
  • Psoralen A dry mature fruit of the leguminous psoralen Psoralea corylifolia L.
  • the traditional Chinese medicine composition of each aspect of the present invention can be decoctioned by water after the traditional method, or can be processed according to the preparation, and suitable auxiliary materials are added to prepare various clinically required dosage forms, including tablets, granules and capsules.
  • the agent, the pill, the oral liquid, the soft capsule, etc.; the auxiliary material includes a solvent, a disintegrant, a flavoring agent, a preservative, a coloring agent, a binder, a lubricant, and the like.
  • the inventors provide a method of preparation comprising the steps of:
  • step D Combine Rehmannia glutinosa, Epimedium, Astragalus, Cistanche, Gardenia, Yam and the slag obtained in steps B and C, add water to decoct 2 ⁇ 3 times, each time for 1 ⁇ 2 hours, combine water decoction and The extract of the extract in the step B, the relative density of 1. 25 ⁇ 1. 35, the standby;
  • step E Combine the extracts of steps C and D, vacuum dry, pulverize into dry paste powder, add velvet powder and beta-cyclodextrin inclusion compound of step B, and prepare the desired dosage form, including tablets, granules, Capsules, pills, soft capsules, etc.
  • the inventors provide a method of preparing a tablet, the method comprising the steps of:
  • the traditional Chinese medicine composition of the present invention contains various active ingredients, especially the content of icariin which affects the production The quality of the product. Therefore, in order to detect the content of each active ingredient in the traditional Chinese medicine composition, in particular, the content of icariin, the inventors have also provided a method for detecting an active ingredient, in addition to the conventional test items of pharmacy, The following qualitative identification and content determination methods are included.
  • the content determination method is:
  • Liquid chromatography conditions using 18 ⁇ ⁇ silicon germanium bonded silica as a filler; volume 28: 72 acetonitrile-water mixture as mobile phase; detection wavelength is 270nm ; theoretical plate number according to icariin peak should be calculated Not less than 1500;
  • Preparation of the reference solution accurately weigh the icariin reference substance, add methanol to make a solution containing 0.1 mg per 1 ml, that is;
  • Preparation of the test solution Take the traditional Chinese medicine composition 0. 3g ⁇ 0. 5g, accurately weighed, placed in a conical flask, precision added 25ml of diluted ethanol, weighed, sonicated for 30 minutes, then weighed The weight of the lost weight is made up with dilute ethanol, shaken, filtered through a microporous membrane of 0. 45 ⁇ ⁇ , and the filtrate is taken, that is, obtained;
  • Assay Accurately draw the reference solution and the test solution for each ⁇ ⁇ ⁇ , inject into the liquid chromatograph, measure and calculate the data.
  • the qualitative identification method includes the following items:
  • test solution another take astragaloside reference substance, add methanol to make lmg solution per lml, as a reference solution; according to the Chinese Pharmacopoeia thin layer chromatography test, draw the test solution ⁇ , the reference solution 5 ⁇ 1, respectively Point on the same silica gel G thin-layer plate, a mixture of dichloromethane-methanol-water in a volume ratio of 13:7:2 as a developing solvent, unroll, take out, dry, spray with 10% sulfuric acid ethanol solution, 105 ⁇ Heating to the spot to clear the color; in the chromatogram of the test sample, in the position corresponding to the chromatogram of the reference substance, the spot of the same color is displayed under sunlight;
  • the traditional Chinese medicine composition of each group of the invention has the effects of tonifying the kidney and strengthening the yang, and correcting the poisoning effect, and can be used for treating AIDS and improving various complications. It has been experimentally proved that the traditional Chinese medicine composition of the first embodiment of the present invention can effectively inhibit HIV, protect the immune system of experimental animals, and have an aphrodisiac effect on experimental animals; the traditional Chinese medicine composition of the second embodiment can further improve the constitution and appetite of the model animals. Reducing discomfort such as diarrhea; Chinese medicine combination #1 of Option 3 can comprehensively improve the therapeutic effect, replenish spleen and kidney, lead qi stagnation, and improve the quality of life of model animals and patients.
  • Treatment was started 71 days after 1 ml, and were randomly divided into SIV control group, low dose group and high dose group, with 4 test monkeys in each group.
  • the low-dose group is equivalent to the human clinical therapeutic amount, ie, 0. 338g/Kg;
  • the high-dose group is equivalent to three times the low-dose group, ie, 1.014g/Kg, once a day, continuous administration for 8 weeks. , without interruption in the middle, continue to observe for 8 weeks after stopping the drug.
  • Each was formulated into an aqueous suspension of 100 ml, and administered according to the actual body weight of the monkey.
  • the SIV control group was an untreated group, and the same amount of warm boiled water was administered for 8 weeks.
  • the inhibitory effect of Aifuping tablets on monkey immunodeficiency virus (SIV)-infected monkey model virus The fluctuation of viral load in SIV control group after SIV infection is within a certain range, which is consistent with the natural variation of SIV infection. After the treatment in the low-dose group, the viral load decreased significantly, especially at 8 weeks after stopping the drug, and decreased by 1. 52 log compared with that before the treatment. 1. 34 log o Avoplanin high-dose group except one In addition to the accidental death of monkeys, the viral load of other monkeys also decreased significantly. The treatment group did not show a virus rebound after stopping the drug. Therefore, it can be considered that the experimental results suggest that Avovir tablets have a significant inhibitory effect on the SIV-infected monkey model.
  • the protective effect of Aifuping tablets on the immune system of monkey immunodeficiency virus (SIV) infected monkey model The monkey lymph node biopsy showed that the lymph node structure of the control group gradually deteriorated with the prolongation of the disease course, which is consistent with the SIV infection model.
  • the pathological changes of the natural pathology the high-dose group in the treatment group was examined for lymph node examination, and its structure was slightly worse, but it was significantly better than the control group; the tissue structure of the low-dose group did not deteriorate with the disease course, but stabilized.
  • the direction of development It is suggested that Avopine has a certain protective effect on the immune system, and the low dose group is better than the high dose group.
  • the penile erection time of the rats was recorded after local electrical stimulation. On the 29th day, the rats in each group were sacrificed. The foreskin gland, seminal vesicle, prostate and levator ani muscle were removed, weighed, and the organ index was calculated.
  • Experimental drug 1
  • the drug of the invention as above, is made into a dry powder.
  • 2 positive drugs ⁇ Fuzheng granules (national medicine Zhunzi Z22022497) Jilin Tonghua Shenyuan Pharmaceutical Co., Ltd. production.
  • Cyclosporin A Produced by Swiss Novartis Pharmaceuticals.
  • mice Adult oral Avo Fu Ping dry powder 5. 8 g, is 0. 08319 g dry powder ⁇ kg - 1 body weight.
  • the equivalent dose of the mouse is 0. 754 g dry powder, kg- 1 body weight.
  • the equivalent dose of the mouse drug is used as the low dose; the equivalent dose is twice the medium dose; the equivalent dose is 4 times the high dose.
  • the adult dose of positive drug is 30g per day, which is 0.43g ⁇ kg" 1 body weight.
  • the amount of mice is twice the equivalent dose, that is, 8 g dry powder * kg - 1 body weight. Animals are randomly divided into groups of 12 animals.
  • Lymphocyte subsets detection bleeding in the eyelids of mice, anticoagulation of heparin. 0. lml take anticoagulant and CD: i, CD 4, CD 8 , and CD 19 monoclonal antibody to a fluorescent binding 4 ⁇ incubated for 30 minutes followed by lymphocyte subsets by flow cytometry.
  • the maximum concentration of Aifuping tablets was 2.46g crude drug/ml, and the mice were given 2 times/24h at the maximum concentration of maximum gavage volume (0.8 ml/20g).
  • the cumulative dose was 197g/kg, which is equivalent to clinical adults.
  • the dosage was 477 times (the clinical adult daily dose of 24.78g crude drug / 60 kg), the animal showed no obvious side effects, suggesting that the drug is safe and non-toxic in large doses.
  • Hematological indicators There was no significant difference in the majority of hematology indicators between the groups. The difference between the few doses of the different dose groups and the blank group was statistically significant, but it was basically within the normal range.
  • Blood biochemical indicators There was no significant difference in the blood biochemical indicators of each group. A few different indicators also returned to normal after one month of restorative observation.
  • Decoction 30g Epimedium 120g, Astragalus 120g, Cnidium 120g, Hawthorn 120g, Rehmannia glutinosa 240g - boiled twice, add 10 times the amount of water each time.
  • the decoction is taken orally and served on the same day for 6 months. Viral load is controlled to inhibit water 1Q level, the patient's self-inductive physical strength is significantly enhanced, and the quality of life is significantly improved.
  • the prescription was applied to treat more than 30 cases of AIDS patients, with an effective rate of 92%.
  • Deer antler 45g Epimedium 150g, Astragalus 150g, Cnidium 150g, Hawthorn 150g, Rehmannia glutinosa 300g. Usage: Oral decoction.
  • antler 42g epimedium 140g, astragalus 140g, Cnidium 140g, Hawthorn 140g, Rehmannia 280g.
  • Usage Oral decoction; or powdered antler, combined with water extract concentrate of other APIs, dried, crushed, and packed into capsules.
  • the side has been used to treat more than 70 cases of AIDS patients, with an effective rate of 96%.
  • antler 300g epimedium 1200g, astragalus 1200g, Cnidium 1200g, Hawthorn 1200g, Rehmannia glutinosa 2400g, Curculigo 1200g, Nutmeg 1200g, Yam 1200g.
  • step (2) (4) Combine rehmannia root, epimedium, astragalus, yam and the dregs obtained in step (2) (3), add enough water to cook twice, each time for 1 hour, combine water decoction and steps (2)
  • the obtained aqueous solution is concentrated under reduced pressure to an extract having a relative density of 1.25 to 1.30 at 60 ° C, and used;
  • step (2) (4) Combine rehmannia root, epimedium, astragalus, yam and the dregs obtained in step (2) (3), add water to cook for 3 times, add 5 times of water each time, cook for 2 hours, combine with water to cook.
  • the cooking liquid and the aqueous solution obtained in the step (2) are concentrated under reduced pressure to an extract having a relative density of 1.30 to 1.35 at 60 ° C, and used;
  • the ethanol extract is combined, the ethanol is recovered, and the extract having a relative density of 1.30 to 1.32 is concentrated to 6 CTC under reduced pressure, and the extract and the dregs are reserved; (3) Decoction of Rehmannia glutinosa, Epimedium, Astragalus and Chinese yam twice, the first time with 10 times the amount of water for 2 hours, the second time with the step (2) to obtain the dregs, add 8 times the amount Decoction for 1.5 hours, combined with water decoction, concentrated to 6CTC, the relative density of 1.05 ⁇ 1.10 clear paste, high-speed centrifugation, separate the centrate, continue to concentrate under reduced pressure to 6CTC, the relative density is about 1.30 ⁇ 1.32 Extract, spare;
  • step (2) (4) Combine rehmannia root, epimedium, astragalus, yam and the dregs obtained in step (2) (3), add water for 3 times, and add 1 time 12 times water for 1.5 hours, 2, 3 Add 8 times the amount of water for 1 hour, combine the water decoction liquid and the aqueous solution obtained in step (2), and concentrate to a concentration of 1.26 ⁇ 1.28 of the extract at 60 ⁇ under reduced pressure, and set aside;
  • antler 450g epimedium 1500g, astragalus 1500g, Cnidium 1500g, Hawthorn 1500g, Rehmannia glutinosa 3000g, Curculigo 1500g, Nutmeg 1500g, Yam 1500g.
  • antler 450g epimedium 1500g, astragalus 1500g, Cnidium 1500g, Hawthorn 1300g, Rehmannia glutinosa 2600g, Curculigo 1300g, nutmeg 1300g, Yam 1300g.
  • step (2) (4) Combine rehmannia root, epimedium, astragalus, yam and the dregs obtained in step (2) (3), add water to cook for 3 times, add 5 times of water each time, cook for 2 hours, combine with water to cook.
  • the cooking liquid and the aqueous solution obtained in the step (2) are concentrated under reduced pressure to an extract having a relative density of 1.30 to 1.35 at 60 ° C, and used;
  • step (2) (4) Combine Rehmannia glutinosa, Epimedium, Astragalus, Cistanche, Gardenia, Yam and the dregs obtained in step (2) (3), add enough water to cook twice, each time for 1 hour, combined with water The immersion of the extract, and the relative density of the granules of 1. 25 ⁇ 1. 30, spare;
  • step (2) (4) Combine Rehmannia glutinosa, Epimedium, Astragalus, Cistanche, Gardenia, Yam and the dregs obtained in step (2) (3), add water for 3 times, add 5 times of water each time, and cook 2 times.
  • the extract of the extract is used in an amount of 1. 30 ⁇ 1. 35 of the extract;
  • the side was used to treat more than 80 cases of AIDS patients, with an effective rate of 96.2%.
  • Example 18 The prescription: antler 4kg, epimedium 13kg, astragalus 13kg, Cnidium 13kg, hawthorn 13kg, rehmannia root 26kg, curculigo 13kg, nutmeg 13kg, yam 13kg, medlar 13kg, Cistanche 13kg, psoralen 6. 5kg.
  • Extract Hawthorn, Curculigo, Cnidium, and psoralen with 6 times 80% ethanol for 3 times, add 8 times for the first time for 2 hours, and add 2 times for the second and third times for 5 hours. , the extracts of the extracts, the extracts and the dregs of the extracts;
  • step (2) (4) Combine Rehmannia glutinosa, Epimedium, Astragalus, Cistanche, Gardenia, Yam and the dregs obtained in step (2) (3), add water for 3 times, and add 12 times the amount of water for the first time. 5 ⁇ The immersed in the second and third times, the second and third times, the amount of water was decocted for 1 hour, the water was added to the water and the aqueous solution was condensed to a concentration of 1.26 ⁇ 1. Paste
  • antler 5kg, epimedium 15kg, astragalus 15kg, Cnidium 15kg, hawthorn 15kg, rehmannia root 30kg, curculigo 15kg, nutmeg 15kg, yam 15kg, hazelnut 15kg, Cistanche 15kg, psoralen 7. 5g .
  • antler 4.5kg, epimedium 15kg, astragalus 13kg, Cnidium 13kg, hawthorn 15kg, rehmannia root 30kg, curculigo 15kg, nutmeg 15kg, yam 13kg, medlar 13kg, Cistanche 13kg, psoralen 6.5kg.
  • step (2) Decoction of Rehmannia glutinosa, Epimedium, Astragalus, Cistanche, Radix and Chinese yam twice, first time with 10 times water for 2 hours, second time with step (2) (3) Dilute the dregs, add 8 times the amount of water to decoct for 1.5 hours, combine the decoction liquid and the aqueous solution obtained in step (2), concentrate under reduced pressure to a clear density of 1.05 ⁇ 1.10 at 60C, centrifuge at high speed, and separate the centrifugation solution. And continue to concentrate under reduced pressure to 60 ⁇ when the relative density is about 1.30 ⁇ 1.32 of the extract, spare;
  • Example 21 Prescription: antler 4.2g, epimedium 14kg, astragalus 14kg, Cnidium 14kg, hawthorn 14kg, rehmannia root 28kg, curculigo 14kg, nutmeg 14kg, yam 14kg, wolfberry 14kg, Cistanche 14kg, psoralen 7kg.
  • step (2) (4) Decoction of Rehmannia glutinosa, Epimedium, Astragalus, Cistanche, Radix and Chinese yam twice, the first time with 12 times the amount of water for 1.5 hours, the second time and step (2) (3) Dilute the dregs, add 8 times the amount of water for 1 hour, combine the decoction liquid and the aqueous solution obtained in step (2), concentrate under reduced pressure to a clear density of 1.05 ⁇ 1.10 at 60 ° C, centrifuge at high speed, and separate. Centrifugal liquid, continue to concentrate under reduced pressure to 60 ° C, the relative density of about 1.28 ⁇ 1.30 of the extract, spare;
  • the side has been used to treat more than 200 cases of AIDS patients, with a total effective rate of 97%.
  • Example 22 Quality inspection of the tablets obtained in Example 21
  • the n-butanol solution was evaporated to dryness on a water bath, and the residue was added with water 10 ml of warming to dissolve, and allowed to cool.
  • the D-101 macroporous adsorption resin column (inner diameter: 1.5 cm, length 12 cm) was eluted with 50 ml of water, and water was discarded.
  • the solution was eluted with 30 ml of 40% ethanol and the eluent was discarded. After eluting with 50 ml of 70% ethanol, the eluate was collected, evaporated to dryness, and the residue was dissolved in methanol (2 ml) to dissolve.
  • Chromatographic conditions and system suitability test octadecyl silicon germanium bonded silica as a filler; acetonitrile-water (28: 72) as mobile phase; detection wavelength is 270 dishes.
  • the number of theoretical plates should be no less than 1500 according to the peak of icariin.
  • Preparation of the reference solution Accurately weigh the appropriate amount of icariin reference substance, add methanol to make a solution containing 0.1 mg per lml, that is.
  • Preparation of the test solution Take 20 pieces of this product, remove the film coat, grind finely, take about 0. 5g, accurately weighed, set in a conical flask, precision added 25ml of dilute ethanol, weighed, sonicated (power: 240W, frequency: 45kHz) 30 minutes, weigh the weight, make up the lost weight with dilute ethanol, shake well, filter with microporous membrane (0. 45 ⁇ ⁇ ), take the filtrate, get .

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Abstract

La présente invention concerne une composition pharmaceutique pour le traitement du SIDA, un procédé de préparation, un procédé de test et son utilisation. Ladite composition pharmaceutique est préparée à partir des matières premières extraites de Rhizoma Dioscoreae, Rhizoma Curculiginis, Fructus Lycii, Radix Rehmanniae, Radix rehmanniae Preparata preparatum, Herba Cistanches, Fructus Psoraleae, Radix Astragali, Fructus Corni, Herba Epimedii, Fructus Cnidii, Semen Myristicae, Cornu Cervi Pantotrichum, etc.
PCT/CN2010/001968 2010-03-17 2010-12-06 Composition pharmaceutique pour le traitement du sida, et procédé de préparation associé WO2011113190A1 (fr)

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CN2010101258953A CN102188537B (zh) 2010-03-17 2010-03-17 一种用于抗艾滋病的中药组合物及其制备方法

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Cited By (4)

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CN108226313A (zh) * 2016-12-15 2018-06-29 上海医药工业研究院 地黄中苷类成分的同时测定及指纹图谱构建方法
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CN109085257A (zh) * 2018-07-05 2018-12-25 中央民族大学 一种同时定量检测小鼠血浆中黄芪甲苷-iv、环黄芪醇的方法
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CN108226313A (zh) * 2016-12-15 2018-06-29 上海医药工业研究院 地黄中苷类成分的同时测定及指纹图谱构建方法
CN108226313B (zh) * 2016-12-15 2021-07-30 上海医药工业研究院 地黄中苷类成分的同时测定及指纹图谱构建方法
CN108956811A (zh) * 2018-06-12 2018-12-07 江苏颐海药业有限责任公司 一种用于“益心通络口服液”制剂的质量控制方法
CN109085257A (zh) * 2018-07-05 2018-12-25 中央民族大学 一种同时定量检测小鼠血浆中黄芪甲苷-iv、环黄芪醇的方法
CN109085257B (zh) * 2018-07-05 2021-04-06 中央民族大学 一种同时定量检测小鼠血浆中黄芪甲苷-iv、环黄芪醇的方法
CN113281439A (zh) * 2021-07-25 2021-08-20 江西汇仁药业股份有限公司 肾宝片的质量控制检测方法

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