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

作　　者：高永宾 张久胜 

机构地区：[1]神威药业,河北栾城051430

出　　处：《亚太传统医药》2013年第2期21-22,共2页Asia-Pacific Traditional Medicine

摘　　要：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.

关 键 词：清开灵软胶囊 微生物检查 平皿法 回收率 

分 类 号：R927[医药卫生—药学]