氧氟沙星滴耳液微生物限度检查方法验证

Validation Method for Microbial Limits of Ofloxacin Ear Drops

目的对氧氟沙星滴耳液微生物限度检查方法进行方法学验证。方法采用薄膜过滤法检验,采用《中国药典》2005年版收载的方法进行验证。结果五种菌株的回收率均高于70%,且控制菌检查具有专属性。结论采用薄膜过滤法检查氧氟沙星滴耳液微生物限度可行。

Objective To establish the method of microbial limit for Ofloxacin Ear Drops. Methods Filtration and verification method of Chinese Pharmacopoeia 2005 were used. Results The recoveries were more than 70% and the quality of control germ check was credible. Conclusion Membrane filtration method can be used in microbial limit test for Ofloxacin Ear Drops.