清开灵软胶囊微生物限度检查方法验证

Validation of Test for Specified Micro-organism of Qingkailing Soft Capsule

目的:确认所采用的检验方法适合于清开灵软胶囊的微生物限度检查计数检验。方法:该药在制备供试液时采用加入乳化剂的方法,制成1∶20的供试液,细菌、霉菌及酵母菌计数方法为平皿法。结果:各组实验回收率均大于70%。结论:清开灵软胶囊的微生物限度检查计数方法可采用平皿法。

Objective： A test for specified micro-organisms of Qingkailing Soft Capsule was established. Methods：To make a one in twenty dilution of original product with suitable sterile surface-active agent . The plate-count method is reserved for bacteria , fungi and microzyme. Result： The ratio of recovery is more than 70 percent. Conclusion： The plate-count method is suit for test for specified micro-organisms of Qingkailing Soft Capsule.