29种医院制剂微生物限度检查方法验证

目的:建立本院29种医院制剂的微生物限度检查方法。方法:按2005年版《中国药典》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。结果:采用常规法试验29个医院制剂中有16种对不同的试验菌的回收率低于70%、控制菌检查中有6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验证,才能保证检验结果的正确性。

Validation of Microbial Limit Test Method of 29 Kinds of Hospital Preparations

OBJECTIVE:To establish a method for the microbial limit test of 29 hospital preparations.METHODS: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).RESULTS:The recoveries of test organisms in 16 of the total 29 preparations by routine method were less than 70%,and the test organisms were failed to be detected in 6 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.