黄藤素片微生物检验方法验证中加菌方法的比较研究

A study on the microbiology verifying test of Huangtengsu tablet with bacterial put in

目的:比较黄藤素片微生物方法验证中的加菌方法不同,所出现的回收率差异。方法:采用离心法-薄膜过滤法弃除黄藤素片中的抑菌成分。结果:离心前加入阳性对照菌所得回收率非常低,采用薄膜过滤法的阳性对照菌所得回收率可达70%以上,两者有显著性差异。结论:薄膜过滤法最后一次冲洗加入阳性对照菌仅能说明黄藤素片的抑菌作用可采用离心-薄膜过滤法弃除,而不能反映该药品在生产、运输、贮藏过程所污染的微生物。

Objective：To compare the different recovery rates resulted from different methods in putting bacterial in microbiology verifying test of Huangtengsu tablet. Methods： The centrifugalization and membrane filtration were used to get rid of the components restraining bacterial from Huangtengsu tablet. Results： The recovery rate of the bacterial put into drug before centrifugalization was evidently different from that after the last washing of membance Kltration. Conclusions： The result of putting bacterial into drug after membrane filtration may not illustrate some bacterial contaminated in production, transportation and garner.