Prepatation And Evaluation Of Fufang Kushen Zhili Tablets

Objective: To preparate and evaluate the Traditional Chinese Medicine named Fufang Kushen Zhili Tablets used to treat bacillary dysentery,and then,study on its preparation process, quality standard.Methods: Pharmaceutical indicators results is an important index for the choice of the preparation process.Determine the detail technological parameter by single factor experiment and orthogonal experiment. And investigate the molding process of the tablet.Appropriate identification of three Herbs were made by TLC; Matrine and Oxymatrine were measured respectively by HPLC.Results: Sophora flavescens, Caulis Mahonia and Areca catechu, were Shattered to coarse particle,add 0.3% sulfuric acid solution(10 times for the first time,8 times for the second times),warm immersion extraction stir 2 times under 50 ℃, 2.0 hours each time, filter and combine the filtrate. The filtrate was regulated to adjust pH value to 5~6 with lime milk,then filter, the filtrates was concentrated under vacuum to the relative density was 1.30~1.35(60℃) and dried under decompression to reserve. Volatile Oil of Garlic Elsholtzia is collected by distillation and then preparated for cinnamaldehyde-β-cyclodextrin. The ration of paeonolofβ-cyclodextrin and water was 1:5:15(mixing for 2h). Drying the inclusions under 45 ~ 50 ℃ to reserve. The powder was added to 30 g microcrystalline cellulose, a moderate amount of starch,90% ethanol for making granules,then drying and adding 3g magnesium stearate for making 1000 tablets. Spots were obtained from the test solutions and without interference. The content of Matrine and Oxymatrine was no less than 3.1mg each tablet.Conclusion: The preparation process of the Fufang Kushen zhili Tablets was steady; the quality of the tablets can be controlled and the determination methods can be reproduced.