The prescription is derived from the experience of the Chinese-American Mr. Duan Rongshu in the treatment of AIDS in Africa and America. The preparation has been developed more than 20 years before the clinical application history. It is proved that it has good development value, but no obvious adverse reaction is found. After the species was established, a more systematic experimental study was conducted. The Hunan Provincial Institute of Traditional Chinese Medicine was responsible for the pharmaceutical research of Ai FuPing Tablets, the Institute of Basic Theories of Chinese Academy of Traditional Chinese Medicine, the Chinese People's Liberation Army AIDS Detection and Confirmation Laboratory, and The Institute of Tropical Medicine, the Guangzhou University of Traditional Chinese Medicine. Hunan Provincial University of Traditional Chinese Medicine and its first affiliated hospital, a total of five units are responsible for the pharmacological toxicology of Ai FuPing Tablets. 

　

Summary of the main findings

1. Pharmacology and Toxicology

12 monkeys was successfully infected with SIV on 71 days after infection. After treatment, the virus load in the treatment group decreased significantly, especially at 8 weeks after withdrawal, the virus load was 1.52 log lower than that before treatment, and 1.34 log lower than that in the SIV control group. Therefore, it can be concluded that the experimental results suggest that the low dose of Ai FuPing’s has a efficacious inhibitory effect on SIV infected monkey model, and there is no virus rebound phenomenon after stopping this product.

Comparing to control group, Lymph node biopsy in treatment monkeys with low dose of Ai FuPing showed better clinical result and this product had better protective and reconstructive effects on the immune system.

Ai FuPing has a certain promotion effect on increasing the CD4 + T cell level and the CD4 + / CD8 + T cell ratio.
The maximum concentration of Ai Fu Ping tablet was 2.46G /ml. The mice were given two times a day with the maximum concentration and maximum volume of gavage. At this time, the cumulative dosage reached 197 g/kg, which was 476 times the dosage of clinical adults. No obvious toxic and side effects were observed in the animals, suggesting that this product was basically safe and non-toxic.

Ai FuPing tablets were administered continuously to rats for 6 months at 24.6g crude medicine /kg * D, 12.3g crude medicine /kg * D and 6.15g crude medicine /kg * D (59.56, 29.78 and 14.89 times the dose of 60 kg adults respectively). The results showed that the general condition, weight gain and hematology of rats during administration and recovery observation period (1 month) were better than those in control group. There were no significant differences or abnormalities in blood biochemical indexes, main biomarkers , naked eye observation and microscopic histomorphological observation, which indicated that this medicine was safer to take in the clinical dosage range.

2. Clinical

The way of composition, active ingredients selection and formulation of Ai FuPing Tablets conform to the theory of traditional Chinese medicine and the etiology and pathogenesis of the disease. It has obvious advantages among the similar products.

From 1992 to 1993, 239 cases of AIDS patients were treated with traditional Chinese medicine in Kenya. All of them were HIV-positive and combined with one or more opportunistic infections, of which 12 had been treated with other anti-AIDS drugs and 227 (94.9%) had no other treatment. Fever, emaciation, diarrhea, pruritus, cough, loss of appetite, insomnia, loss of libido and enlargement of lymph nodes were the most common symptoms and signs. All of them were treated with Chinese herbal medicine, 2~3 capsules / times, 2~3 times / day, served after dinner, served with boiled water. Repeat for 22~25 days and rest for 6~7 days. 83.7% of the patients took medicine for less than 99 days, and only 14 patients (200) took medicine for 200 days or more. The total effective rate of symptoms improvement was 97.5%. Among the patients who took medicine for more than 200 days, 14 cases were examined, and 3 cases of HIV were negative, accounting for 21.4%. The above results suggest that Duan's experience prescription is an effective prescription for AIDS treatment, and has the potential and value for development.

3. Comprehensive analysis and evaluation

This prescription is the experience of Chinese American Mr. Duan Rongshu in treating AIDS in Africa and America. It has been used for more than 20 years before its development. It has been preliminarily proved that it has good development value and no obvious adverse reactions have been found.

Through literature research and experimental research, the extraction, separation and purification methods of each medicinal flavor in the prescription were determined, and Ai FuPing tablets were prepared. The quality standard and content limit of Ai FuPing tablets were established by systematic study. The above research provides a guarantee for the follow-up study of Ai FuPing tablet. Pharmacological and toxicological studies showed that this product was safer in clinical use. Ai FuPing had a better inhibitory effect on SIV-infected monkey models, and no virus rebound occurred after withdrawal. It also had a better protective and reconstructive effect on the immune system comparing to control group. Ai FuPing in tablets restored the immune function of immunosuppressed mice. Ai FuPing has no direct inhibitory effect on HIV-1 in vitro, but its inhibitory effect on HIV in vivo needs further verification in clinical trials. Pharmaceutical, pharmacological and toxicological studies and clinical trial design protocol are reasonable, scientific and standardized, reflecting in certain extent the effectiveness and safety of Ai FuPing tablets in the treatment of AIDS, which provides a basis for the clinical research of this project.

A. Quality controllability

The preparation process of Ai FuPing tablets is reasonable and the quality standard is feasible. The formulation of Ai FuPing tablets does not contain toxic medicines, and there is no contraindication against 18  compatibility princeples. No toxic reagents are mixed in the preparation process, which can ensure the safety and effectiveness of patients in the process of using Ai FuPing tablets. Microscopic identification method and TLC identification method were established, and methodological investigation of effective content determination method was carried out. It provides an effective guarantee for the quality control of Ai FuPing tablets.

B. Safety

The results of acute toxicity test showed that mice were given twice a day with the maximum concentration and maximum volume of gavage. At this time, the cumulative dosage reached 197 g/kg, which was 476 times the dosage of clinical adults. No obvious toxic and side effects were observed in animals. The results of long-term toxicity test showed that there were no significant differences or abnormalities in the indexes, main organ coefficients, naked eye observation and Microscopic histomorphological observation of rats after 6 months of continuous gastric administration compared with the blank control group.

According to the theory of traditional Chinese medicine and clinical application experience, the clinical application of various medicinal flavors in prescriptions and the results of modern application research, the dosage range of this preparation in clinical application is relatively safe.

C. clinical effect

Ai FuPing tablet is classified as new medicine category VI, and developed on the basis of traditional Chinese medicine theory and clinical application experience of this product, prescription composition, background materials of clinical application and modern research progress. The results of pharmacodynamics test showed that Ai FuPing had effective inhibitory effect on SIV infected monkey model, and no virus rebound was observed after medicine withdrawal, and it also had good protective and reconstructive effect on the immune system. The experimental study of Ai FuPing tablets for enhancing recovery of immune function in immunosuppressed mice showed that Ai FuPing tablets could improve the level of CD4 + T cells and the ratio of CD4+/CD8+T cells. To sum up, it shows that Ai FuPing tablets could be effective in the treatment of AIDS.

Ai FuPing tablets can reduce the clinical symptoms of AIDS (including fatigue, alopecia, diarrhea, etc.) and improve the quality of life of AIDS patients. It has been used for more than 20 years before its development. It has proved that it has a good development value, no obvious adverse reactions were found.

If the patient likes the candy, in a common condition, an adult patient should take 10 grams of candies a day, each candy is about half gram. If the patient prefers the herbal powder pill, in a common condition, an adult patient should take 10 grams of herbal powder pills a day, separately in three times, 3.3 grams each time. If the patient prefers the tea packets, in a common condition, every tea packet is about 10 grams, and three packets are needed each day. Just decoct a packet with 300 milliliters of water and decoct for five to ten minutes and then the tea could be drunken. A packet could be decocted by another 300 mililiters of water. Each day, three packets are needed. 

   On the beginning, you could order full treatment course for ten persons to check the result. Generally speaking, the ways of candy and tea packets are more convenient in posting and exportation to you than the way of powder pill.