罗红霉素片微生物限度检查法的验证

Verification of microbial limit test for Roxithromycin Tablets

目的:验证一种罗红霉素片微生物限度检查的方法。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罗红霉素片微生物限度可行。

Objective:To establish a microbial limit test method for Roxithromycin Tablets.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-filter can be used in microbial limit test for Roxithromycin Tablets.