复方天棘胶囊的初步稳定性试验

THE PREL IMINIARY STABILITY TEST OF TIAN JI CAPSULE COMPOSITION

按照卫生部颁布的《新药审批办法》和《复方天棘胚囊质量标准》的规定要求，本文对新药“复方天棘胶囊”的性状、鉴别、水分、溶散时限、含量测定、装置差异、卫生学检查等７个项目，进行了初步稳定性试验观察，在常温下考察０、１、２、３月，测得四点数据，共考察样品５个批号。其考察结果表明，复方天棘胶囊的质量在０月至３月的结果基本一致，预示其质量稳定，可贮存２年。

he according to comment of 《The rule on admussion of》and 《The quality criteron of Tian Jicomposition(TJCC)》,the studing results showed the initial conclusion of stsbility of TJCC in-cluding seven itmes:the nature properties, moisture,compositive indetification,diffusion time in37 C distilled water,effective compositions, average weight loading and hygienical requires Inroom temperature,from zero to three months,we inspected five sets of samples and got four se-vies of data;the qualities of TJCC shows that all items are very stable during four months and theTJCC can kept two years in room temperature is no doubt