WO1996036345A1 - An anti-aids semifluid extract of traditional chinese medicines and preparation thereof - Google Patents

Abstract

The invention relates to an anti-AIDS semifluid extract of traditional chinese medicines and preparation thereof. The semifluid extract consists of extracts of chinese drugs that contain Radix Codonopsis Pilosulae Rhizoma Atractylodes Macrocephalae, Poria, Radix Glycyrrhizae, Radix Astragali seu Hedysari, Radix Rehmanniae, Preaparata, Radix Angelicae Sinensis, Radix Paeoniae Alba, Colla Corii Asini, Cortex Eucommiae, Radix Dipsaci, Fructus Lycii, Fructus Corni, Fructus Rubi and Rhizoma Alismatis, tween-80, sodium benzoate and sugar. Said extract can be used to treat AIDS and its related syndrome.

Description

 Anti-AIDS Chinese medicine fried scallion and preparation method thereof

 Traditional Chinese medicine anti-AIDS breeding, also known as "Chinese medicine life spring" and its preparation method, belongs to the technical field of traditional Chinese medicine anti-AIDS medical preparations composed of plant materials.

 Technical background of the invention

At present, AIDS has spread to more than 160 countries and regions around the world. It is showing a clear upward trend in Asia. AIDS is an autoimmune disease mainly manifested by cellular immune deficiency caused by HIV infection, and its treatment includes: combating HIV-based virus infection and other conditional pathogen infection, regulating immune function, treating malignant diseases (such as card (Bosch's sarcoma, lymphoma) and supportive therapies. It is reported that no less than 50 new anti-AIDS drugs are currently being developed in the United States, but only azidothymidine (AZT), dideoxyinosine (DDI), dideoxythymidine (DDT) are approved for clinical use by FD A. ), Dideoxycytidine (DDC), etc. However, these drugs cannot cure AIDS, have large side effects and are expensive. As in the summer of 1993, scholars at the International AIDS Conference in Berlin held a long-term study. Although azidothymidine (AZT) can temporarily relieve the symptoms of AIDS, it quickly develops drug resistance and obvious bone marrow. Suppresses toxicity and therefore cannot prolong the lives of people living with HIV and AIDS. In view of this, in the past ten years, many scholars in China have conducted immunopathological research on Chinese herbal medicine and Chinese herbal compound preparations. In terms of its effect on immune function classification and clinical trial effect ^ — determined effectiveness. The pharmacological effects of Chinese herbal medicine and its compound preparations are reflected in the following aspects: fight against viruses and certain opportunistic infections, improve or suppress the body's immune function and its effect on immune function, and the two-way regulation mechanism. At present, the traditional Chinese medicines used to treat AIDS at home and abroad are: glycyrrhizin (ie Qiangli Ning), Bawei astragalus tablets, Xiangru polysaccharides and so on. It is reported that these Chinese medicines have the effect of inhibiting the formation of HIV and the degeneration of infected cells, and have a certain effect on some AIDS. It is learned from the patent literature search: Before the patent application of the present invention, there have been similar applications of various traditional Chinese medicines for treating AIDS with Chinese medicine as raw materials to the China Patent Office, such as "Production Method of Traditional Chinese Medicine Aidling Preparations" [CN 8810004 8 A (1988); "Preparation Method of Traditional Chinese Medicine Prescriptions for the Prevention and Treatment of AIDS" [CN 1062844 A (1992)]; "A Drug for the Treatment of AIDS" [CN 1092661 A (19 94)]; "Traditional Chinese Herbal Anti-AIDS Preparations" [CN 1 091 64 1 A (1 99'4)] and so on. It can be known from the contents disclosed in the above documents that they are an antiviral, immunity-improving and symptomatic preparation; the preparation method is simple; the administration is convenient; there are no obvious toxic side effects: and they have undergone small clinical trials; they have anti-AIDS effects . Comparing the technical scheme of the present invention with the above-mentioned documents, it can be seen that their technical schemes are different. And the technical scheme of the present invention has been tested by animal tests and clinical trials to prove The feasibility and effectiveness of the Chinese medicine anti-AIDS blues design scheme was discussed.

 The main content of the invention

 The purpose of the present invention is to provide a Chinese medicine preparation for AIDS patients with high efficacy, small side effects, safety and reliability, and cheap price.

The technical scheme for the protection of Chinese medicine against AIDS is as follows: The basic design idea of the technical scheme of the present invention is to choose to promote the rise of CD 4 and CD ₈ lymphocytes; it has two-way regulation of immune function; it can resist inflammation, anti-virus and improve The Chinese herbal medicine of the body's nutritional status is the raw material component. According to clinical trials, research and analysis formulate the corresponding component proportion and its production process. According to this component, weight ratio and technological process, Chinese medicine can be prepared to fight AIDS.

 The components and weight ratios of Chinese medicines against AIDS are as follows: Dangshen 12 parts, Atractylodes 12 parts, Poria 12 parts, Zhigancao 6 parts, Astragalus 10 parts, Shudi 10 parts, Angelica 6 parts, Baiji 9 10 copies of Ejiao, 10 copies of Eucommia ulmoides, 10 copies of discontinuity, 9 dogwoods, 10 medlars, 10 raspberries, 9 parts of Alisma, 2 parts of Tween-801, 2 parts of sodium benzoate, 330 parts of sugar .

 Traditional Chinese medicine anti-AIDS breeding is prepared according to the following steps.

 (1) Take 12 parts of Codonopsis and 60% ethanol which is 10 times the weight of Codonopsis as a solvent, and use the normal infiltration method for operation. That is, the ginseng is immersed in ethanol for 24 hours, and then infiltrated, and the drug residue is discarded; the ethanol is recovered; the effective ingredients in the ginseng are extracted and concentrated into a thick paste. The relative density is 1.3, and it is reserved. Because of the active ingredients such as saponin, trace elements and amino acids in Codonopsis, it can be extracted with 60% ethanol as a solvent and can reduce the dissolution of impurities such as starch.

 (2) Take 10 parts of Ejiao. Warm it to 60 ° C-80 ° C to make it melt evenly and set aside.

 (3) Take 12 parts of Atractylodes, 6 parts of Angelica, 9 parts of Amaranth, 9 parts of Alisma, 10 parts of Raspberry, mix them, and distill at 100 ° C-1 20 ° C for 6 hours. Extract their volatile oil. Experiments show that 98% of the total hair oil can be extracted. Then, the remaining residue is mixed with water and cooked at 100 ° C for 2 hours. After filtration, the residue is discarded. Chemical solution, and then mix the chemical solution with volatile oil for later use.

(4) Take 10 parts of cooked land, 9 parts of dogwood, 10 parts of Eucommia ulmoides, 12 parts of Poria, 10 parts of continuity, 6 parts of Zhigancao, 10 parts of Astragalus and 10 parts of Chinese wolfberry. Cut them into 2-3 inches long, preferably 3-5 mesh, wash them with water, pick them up and drain them. Put them in a pot, add water so that the water surface is 2-3 inches above the medicinal material surface, press the bamboo Plaque. Boil to boiling. While maintaining the boiling state, cook three times in total for 1 hour each time, and filter each time, discard the drug residue, and take the liquid medicine. Combine the three liquid medicines. Concentrate to thick Breeding. Make it a relative density of 1.3. The experiment proves that the above cooking time and extraction times are relatively reasonable.

 (5) Dissolve the concentrated Codonopsis thick green, dissolve the homogeneous Ejiao, Atractylodes, Angelica, Angelica, Alisma, Raspberry hair oil and medicinal liquid mixture, sage, dogwood, eucommia ulmoides, Poria cocos, sclerophylla, licorice , Astragalus, wolfberry mixed thick ¾P to mix. Make it even.

 (6) Take 330 parts of rock candy, heat to dissolve it uniformly, and set aside.

 (7) Mix the thick sound of 15 flavors of Dangshen and other medicines with the uniformly dissolved rock sugar, and heat for another 30 minutes at 60 C-80 ° C.

 (8) Add 15 parts of sodium benzoate and 2 parts of Tween-801 at a time of 15 minutes before the codifying pot of 15 flavor medicines and crystal sugar, such as Codonopsis, and Tween-80 in a state of 1.2g / ral Add. Mix them and collect ¾f, it will become a Chinese medicine to fight AIDS. Its relative density is 1.3. The results of screening experiments prove that it is appropriate to use 2 parts of sodium benzoate and 2 parts of Tween-801 as preservatives and solubilizers.

 In addition, the anti-AIDS drug of Chinese medicine should be tested according to the technical standards of the enterprise.

 According to the above process, a process flow chart can be drawn. As shown in the accompanying drawings.

 The technical requirements of Chinese medicine anti-AIDS ointment are as follows:

 (1) Sensory requirements: tan, sweet, slightly sour. Moderate stickiness. Fine. No visible impurities and no sand.

 (2) Physical and chemical indicators'

 Moisture <1 2.56%

 Total sugar (in sucrose juice) <68

 Fat <0.4 3%

 Protein <1 1.4%

 PH value 4.5-7.0

 Specific gravity 1.3

 (3) Sanitary standards:

 Arsenic (as Asi † mg / kg) 0.5

 Lead (mg / kg as Pb) <1

 Copper (in Cuthng / kg) <1

 (4) Microbiological indicators:

 Total bacteria (· pieces / 9) 1000

 Coliform group (pcs / 1 00) <30

No pathogens can be detected The traditional Chinese medicine anti-AIDS designed and prepared according to the above technical scheme is a best embodiment of the present invention.

 In order to verify the feasibility and effectiveness of the technical scheme designed by the present invention and its beneficial effects compared with existing drugs for treating AIDS. The inventor has carried out a number of experimental studies in collaboration with relevant scientific research and teaching units. The contents of these research projects and their results are briefly described as follows:

 (1) Study on the inhibitory effects of Chinese medicine anti-AIDS ointment on H I V—I (type I human immunodeficiency virus. Type I HIV) and H I v—ll (type II human immunodeficiency virus. Type II HIV). The results prove that: Chinese medicine anti-AIDS spinal AIDS has a mild inhibitory effect on H I V-I in vitro and a significant inhibitory effect on H I V-II.

 (2) Experimental research on the minimum inhibitory concentration (M I C) of Chinese medicine against AIDS. The results of the study proved that the drug has an inhibitory effect on Staphylococcus albicans, Streptococcus, Shigella and Typhoid bacillus.

 (3) Experimental study on the effect of Chinese medicine anti-AIDS ointment on the immune function of mice. The test animals were 6-8 weeks of age. The mice weighed 18-22 g, male and female. They were randomly divided into three groups. Two groups were the control group and one was the experimental group. Experiments have shown that after taking Chinese medicine against AIDS, it can enhance the non-specific immune function, cellular immunity and blood immune function of mice.

 (4) Experimental study on the acute toxicity of Chinese medicine against AIDS. The test animals were 40 mice weighing 18-22 g. The males and females were divided into two groups, and the MTD was 12 Og / kg. It was equivalent to 100 times the human clinical dosage (1.2 g / k g). After 7 days of observation, none of the two groups died. And there were no abnormalities in appearance, behavior, activity, feeding, etc., and no L D 50 was obtained, thus proving that the acute toxicity test was non-toxic.

 (5) Long-term toxicity test of Chinese medicine against HIV / AIDS. The test animals were SD rats, 6-7 weeks old, weighing 80 ± 1 5g, half male and half male. The tadpole group was composed of 7 and 7 animals. The experimental group and the control group were set up. The experimental group was given a large oral dose (in 3.75m 1 / kg, 6. 5m 1 / kg ■ 3m 1 / k 9 three different doses, which is 27 times the clinical dose), after 1 80 days The oral toxicity test found that the weight gain of the tested animals was slower than that of the control group, and the flesh was mildly stagnant. Myocardial fiber atrophy and few myocardial fiber vacuole degeneration were observed in a small number of rats in the high-dose group. But it can return to normal after 4 weeks. This shows that the Chinese medicine has no obvious toxicity against AIDS. It is safe to use according to the prescribed dosage and treatment course.

 (6) Experimental study of the effect of Chinese medicine anti-AIDS on the pituitary-adrenal cortex axis in rats. The test animals were 50 Wistar rats, half male and half male, weighing 1 20 ± 30 g, and the Chinese medicine resisted AIDS was 2 g / ml. The test proved that the drug had no excitatory and inhibitory effects on the rat pituitary-adrenal cortex axis.

Based on animal experiments, clinical trials were conducted. The inventor has used this to treat 27 patients with AIDS and AIDS-related syndromes, including 20 Chinese patients and 7 foreign (Myanmar, Thai) national patients. Including four ethnic groups. It lasted for 3 months and was followed up for another year. The treatment results are as follows: After treatment, the symptoms and signs are significantly improved. The body temperature returns to normal. Diarrhea stops, the rash dissipates or decreases significantly, less opportunistic infections, weight gain, and experimental indicators are improved to varying degrees. Of the 27 cases, 18 cases were markedly effective (accounting for 6 6.7%), 8 cases were effective (accounting for 2 9.6%), were once ineffective, and one case died repeatedly and did not adhere to treatment (accounting for 3 · 7%>.

 The above practice proves that: compared with the similar drugs sold on the market, the traditional Chinese medicine for anti-AIDS breeding has obvious or obvious effects on AIDS; and there are no side effects; safe and reliable; the price is cheap, calculated by one course of treatment Its price is only one-twentieth of that of western medicine.

Claims

Rights request 1. A traditional Chinese medicine anti-AIDS ointment composed of traditional Chinese medicines. It is characterized by the following traditional Chinese medicines, auxiliary materials and weight ratio:  Codonopsis 1 2 servings Baizhu 1 2 servings Poria 1 2 servings  Licorice 6 servings Astragalus 10 servings Matured 10 servings  Angelica 6 parts White peony 9 parts Ejiao 10 parts  Eucommia 10 copies Continued Off 10 copies Dogwood 9  10 Chinese wolfberries, 10 raspberries, 9 diarrhea  Tween 80 1 2 parts sodium benzoate 2 parts rock sugar 330 parts.  2. A method for preparing a traditional Chinese medicine against AIDS and young AIDS according to claim 1, characterized in that it is formulated according to the following process flow:  (1) Take 12 parts of Codonopsis and 10 times the weight of Codonopsis as the solvent, and use the normal infiltration method, that is, immerse for 24 hours, and then perform diafiltration. Discard the drug residue and recover the ethanol. Extract Codonopsis The active ingredients in it make it thick into a thick paste. The relative density is 1.3, spare.  (2) Take 10 parts of Ejiao and warm it to 60 ° C-80. C, Dissolve evenly and set aside. (3) Take 12 parts of Atractylodes, 6 parts of Angelica, 9 parts of Amaranth, 9 parts of Alisma, 10 parts of Raspberry, and mix them. Distill for 6 hours at 100 ° C-1 20 ° C Extract the volatile oil, mix the remaining drug residue with water and cook at 100 ° C for 2 hours, and filter. Discard the drug residue. Take the liquid medicine, and then mix the liquid medicine with hair oil and set aside.  () Take 10 portions of cooked land, 9 portions of dogwood, 10 portions of eucommia ulmoides, 12 portions of Poria cocos, 10 portions of continuation, 6 portions of licorice root, 10 portions of astragalus root, and 10 portions of wolfberry, cut them into sections, wash and drain. Put it in a pot, add water so that the water surface is higher than the medicinal material surface, press the bamboo plaque, boil until it boils, and cook for three times, one time for one hour. And each time it is filtered, discard the medicine residue, take the liquid medicine, and The three parts of the liquid are combined and concentrated to a thick cormorant shape. The relative density is 1.3, and it is reserved.  (5) Thickened Codonopsis sibiricum, melted homogenized Ejiao, a mixture of volatile oil and medicinal liquid of Atractylodes, Angelica, Astragalus, Alisma, Raspberry. And goji berries are mixed to make them 'uniform'  (6) Take 330 portions of rock sugar and heat to dissolve them uniformly.  (7) Mixing thick soup made of 15 flavors of Dangshen and other drugs with uniformly dissolved rock sugar, and heating for another 30 minutes in an environment of 60 ° C-80 ° C, (8) Before Dangshen and other 15 flavors of medicine and rock sugar synthesized «Nourishing pot. 1 '5 minutes, add Add 2 parts of sodium benzoate and 2 parts of Tween-801, of which Tween-80 is added in a state of 1.2 _g / ral ', and they are mixed and creamed to become a traditional Chinese medicine against AIDS.