阿奇霉素胶囊微生物限度测定及方法学验证

Verifying Method Used for Microbial Limit of Azithromcin Capsule

目的:建立阿奇霉素胶囊的微生物限度检查法及方法学验证。方法:采用常规法、离心沉淀薄膜过滤法对阿奇霉素胶囊试验菌回收率的有效性进行评价。结果:常规法试验细菌回收率低于70%,而真菌和酵母菌回收率高于70%;离心沉淀薄膜过滤法的试验细菌回收率高于70%。结论:阿奇霉素胶囊微生物限度检查法可用离心沉淀薄膜过滤法测定细菌数和采用常规法测定霉菌和酵母菌数,该方法可有效去除阿奇霉素胶囊中的抑菌成分,使检验结果更准确、可靠。

[ Objective：To establish a method of microbial limit for azithromcin capsule.Methods：Making an effective evaluation for the recovery rates of azithromcin capsule＇s microbe by common method, eentrifugation and membrane filtration method.Results：The recovery rate of bacterium by common method was less than 70%.While the recovery rate of mold and jeast were more than 70%.The recovery rate of bacterium by centrifugation and membrane filtration method was more than 70%.Conclusion：The number of bacterium in azithromcin capsule was determined by centrifugation and membrane filtration method and the common method was used to examine mold and jeast number.His method can effectively eliminate restraining effect of bacterium and make the conclusion were more accurate and reliable.