妇炎康复片微生物限度检查方法学验证

目的建立妇炎康复片微生物限度检查方法。方法按中国药典方法进行试验,以回收率对方法有效性进行评价。结果采用常规法,5种阳性菌的回收率均70%;采用稀释法,黑曲霉和白色念珠菌的回收率〉70%;用薄膜过滤法,回收率均〉70%。结论用薄膜过滤法能有效去除妇炎康复片中的抑菌活性。该法进行微生物限度检查,可行性强,能达到检测目的。

Validation of method for microbial limit test of fuyankangfu tablets

Aim To establish a method for microbial limit test of fuyankangfu tabehs. Methods The method for microbial limit examination in Chinese Pharmacopoeia was followed. The validation had been tested by recovery. Results With ordinary method, the ratios of all test microbial group were lower than 70%. With dilute method, the ratios of Aspergillus nigers and Candida albicans were higher than 70%. With filtration membrane, all the ratios were higher than 70%. Conclusion The method of filtration membrane can effectively remove the bacteriostasis activeness of fuyankangfu tablets. It is feasible and accurate.