26种医院外用制剂微生物限度检查方法的建立  

Validation of microbial limit test method of 26 kinds of hospital external use preparations

作　　者：刘华[1] 钟国庆 刘大伟 

机构地区：[1]江西省赣州市人民医院,江西赣州341000 [2]江西省赣州市食品药品检验所,江西赣州341000

出　　处：《中国卫生检验杂志》2010年第8期1954-1956,共3页Chinese Journal of Health Laboratory Technology

摘　　要：目的:建立26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》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。结果:采用常规法试验26种医院制剂中有19种对不同的试验菌的回收率低于70%,控制菌检查中有10种制剂试验菌不能检出,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准确性。Objective：To establish a method for the microbial limit test of 26 hospital preparations.Methods： Avalidation 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（2005edition）.Results： The recoveries of test organisms in 19 of the total 26 preparations by routine method were less than70%,and the test organisms were failed to be detected in 10 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.

关 键 词：微生物限度 方法验证 回收率 

分 类 号：R915[医药卫生—微生物与生化药学]