利福喷丁胶囊微生物限度检查方法学验证研究

Validation of method for microbial limit test of rifapentinum capsules.

目的建立利福喷丁胶囊微生物限度检查方法。方法分别采用常规法、离心集菌法、离心集菌＋薄膜过滤法对样品进行微生物限度检查，根据5株阳性菌的回收率结果进行数理统计。结果试验结果表明，利福喷丁胶囊具有较强的抑菌活性，离心沉淀集菌＋薄膜过滤法能有效的去除其抑菌性。结论用该法进行微生物限度检查，可以客观的反映药品中微生物的污染状况，可行性强，能达到检验目的。

Objective To establish a method to determine the microbial limit test for Rifapentinum capsules. Methods Routine method and centrifuging method and centrifuging membrane filtrating methods had different percentage recovery. To determine the antimicrobial effect of Rifapentinum capsules was determined by recovery rate with 5 control trains. Results According to the result, it had higher antimicrobial effects, which should be eliminated by centrifuging membrane filtration. Conclusion The method is simple, fissile and accurate.