Study On Fuhuang Tablet

Hemorrhoid is the common and frequently-occurring disease in clinic. Traditional Chinese medicine (TCM) plays an important role in treating hemmorhoid with the characteristics of treating disease on the basis of symptom, good efficacy of long treatment and little toxicity. TCM compound recipe is the main form for the treatment of disease of Chinese Medicine. The key is to obtain the object of lowering toxicity and enhance efficacy through the drug compatibility. The prescription of Fuhuang Tablet is the concerted recipe of Longhua Hospital affiliated to Shanghai University of TCM and comes from clinic. Fuhuang Tablet is effective and no side effect was found in clinic for more than ten years. In order to enlarge the application scope and serve more people, it is necessary to further develop and satisfy the need of clinic better.In this dissertation, the preclinical research was performed on the basis of the safe and effective concerted prescription in clinic, under the guidance of TCM theory and the requirement of No.6 new drugs. This study mainly includes preparation techniques, quality standard, and stability, and primary pharmacodynamic research.In this dissertation, the preparation technique was studied with index of pharmacology and chemistry and the optimal routie and optimal conditions are as follows: Dried medicinal materials were ground into powder accurately weighed and dipped in 12 times of water for 30 min and then decocted for 1 h. The extraction was repeated in 10 times water. The extracted solution was combined and then concentrated by evaporation till the relative density was about 1.05-1.10 (50℃-60℃), then ethanol was added till the concentration of ethanol was 70%, laying aside and precipitation was appeared. The upper liquid was taken out and evaporated till the relative density was 1.35-1.40(50℃-60℃), then 0.1 times of the weight of the dry extract of starch was added and mixed uniformly, dried under vacuum, ground, screened, add magnesium stearate, mixed uniformly, pressed and coated. The results of the three batches of pilot study indicated the procedure is reasonable and applicable.The study and establishment of the quality standard was performed according to the characteristics and relative requirements of the preparation type of fuhuang tablet. The content of typhaneoside and sophoricoside was determined and the character, the weight diversity and other quality control criteria were also investigated.The stability of Fuhuang Tablet was investigated by acceleration and long term experiment. The results showed that all quality indexes are accorded with regulation and the package material has no side effect on samples.Primary pharmacological experiment showed that the Fuhuang Tablet prepared with the established method has distinct effects of anti- inflammation and hemostasis and it is also has the antibacterial effect of staphylococcus aureus, bacillus subtilis, candida albicans and mildew.