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

作　　者：程红杰 

机构地区：[1]河南省安阳市药品检验所,455000

出　　处：《中国现代药物应用》2009年第16期36-37,共2页Chinese Journal of Modern Drug Application

摘　　要：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.

关 键 词：氧氟沙星滴耳液 微生物限度检查 薄膜过滤法 

分 类 号：R927[医药卫生—药学]