浅析关于三种中药制剂微生物限度检查方法学验证

摘要

Objective To investigate the effects of three kinds of microbial limit examination of TCM and the results of the methodology.Methods According to "Chinese pharmacopoeia" in the method of microorganism limit inspection of nephritis tablet, Jisheng Shenqi capsule, the healthy kidney particles for microbial limit examination.Results Studies have shown that the colony average of test medium to average 70% greater than that of contrast medium colonies, and size of colony morphology and contrast medium colonies, check that the applicability of the medium within the rules.Conclusion The method of microbial limit examination test three kinds of traditional Chinese medicine preparation (nephritis tablet, dhi kidney capsule, the healthy kidney particles), accurate and feasible, simple operation.%目的：探讨三种中药制剂微生物限度检查方法学验证的结果。方法按《中国药典》中微生物限度检查方法对肾炎清片、济生肾气胶囊、健肾颗粒进行微生物限度检查。结果研究显示被检培养基上的菌落平均数大于对照培养基上的菌落平均数70%，且菌落形态大小与对照培养基上菌落一致，说明该培养基的适用性检查符合规定。结论微生物限度检查方法检测三种中药制剂（肾炎清片、济生肾气胶囊、健肾颗粒）中，准确可行，操作简单。