外用制剂微生物限度检查方法研究

Study on Microbial Limit Test Method for Drugs for External Use

目的选择提高外用制剂微生物检出率的检查方法。方法采用直接接种法、培养基稀释法及薄膜过滤法对5种外用制剂进行活菌回收率检查及控制菌的阳性检出情况分析。结果有2个品种采用直接接种法,其活菌回收率均大于70%,控制菌可检出;其他3个品种采用培养基稀释法或薄膜过滤法结合直接接种法,其活菌回收率可达到70%并检出控制菌。结论2个品种的外用制剂可采用直接接种法进行微生物限度检查;其他3个品种需结合直接接种法、培养基稀释法及薄膜过滤法进行微生物限度检查。

Objective To select the correct methods to improve the detecting ratio of viable microorganism in drugs for external use. Methods The direct inoculation method, medium dilution method and membrane filtration method were used in the recovery rate test and control bacteria test of 5 kinds of drugs for external use. Results The recovery rates of two kinds of drugs were more than 70% and the control bacteria could be detected by the direct inoculation method. The medium dilution method and membrane filtration method could help other drugs＇ recovery rate reach more than 70% and the detection of control bacteria. Conclusion Through testing and verifying, the direct inoculation method can be used for microbial limit test of two kinds of drugs. And the direct inoculation method, medium dilution method and membrane filtration method can be used for the others.