21种医院外用制剂微生物限度检查方法学验证

目的：根据《中国药典》2005年版二部附录微生物限度检查法中细菌、霉菌及酵母菌计数方法和控制菌检查法进行验证,发现采用常规法试验21个医院制剂中有14种对不同的试验菌的回收率低于70%、控制菌检查中有8个制剂品种试验菌不能检出,需采用培养基稀释法、薄膜过滤法、离心法、中和法及联用这些方法试验,使试验菌回收率符合要求。结论：被检样品必须进行微生物限度检查方法学验证,才能保证检验结果的准确性。

Validation of Microbial Limit Test Method of 21 Kinds of Hospital External Use Preparations

A validation on the microbial limit test method was conducted in accordance with the counting method of bacteria, mycetes and yeasts and the control bacteria test method stated in the Appendix of China Pharmacopoeia（2005 edition）. The recoveries of test organisms in 14 of the total 21 preparations by routine method were less than 70%, and the test organisms were failed to be detected in 8 preparations in the control bacteria test. For test organisms to meet the standard in recovery rate, medium dilution method, membrane-filter procedure, centrifugal method, neutralization method or the combination of these methods were needed.Conclusion： The test sample should undergo validation on the microbial limit test method to ensure the correctness of test result.