白色洗剂《中国药典》2015年版微生物检查的方法适用性研究  

A Study about the Applicability of Microbiological Examination Methods for White Lotion in Chinese Pharmacopoeia 2015

作　　者：田怀平[1] 王玲[1] 胡燕峰[1] 唐跃年[1] 

机构地区：[1]上海交通大学医学院附属新华医院药学部,上海200092

出　　处：《药学与临床研究》2017年第4期321-324,共4页Pharmaceutical and Clinical Research

摘　　要：目的:建立符合《中国药典》2015年版要求的白色洗剂的微生物检查方法。方法:按照该版药典要求,采用离心沉淀联合薄膜过滤法进行样品前处理,使用5种菌株对白色洗剂进行微生物计数检查和限度菌检查,作为方法适用性验证研究。结果:3个批次的微生物计数检查的5种验证菌株的回收比值均在0.5~2,微生物限度检查的验证菌金黄色葡萄球菌和铜绿假单胞菌均能够检出。结论:白色洗剂的微生物检查方法经验证符合《中国药典》2015年版要求。Objective： To standardize the method of microbiological examination of white lotion re- quired by the Chinese Pharmacopoeia 2015. Methods： The microbial enumeration test and specified microorganisms test were conducted following the instructions from Chinese Pharmacopoeia 2015, the samples were treated by centrifugation and membrane filtration, which involved 3 hatches of white lotion and 5 species of bacteria in all. ResuJts： The recoveries of all kinds of strains in the tests of total aerobic mi- crobial count, total yeast and mold count were at the ratio of 0.5-2.0 in all batches.In the method valida- tions of staphylococcus aureus and pseudomonas aeruginosa, all kinds of strains were respectively detected. Conclusion： The microbiological examination methods for white lotion can meet the requirements of Chinese Pharmacopoeia 2015.

关 键 词：白色洗剂 微生物检查 微生物计数检查 限度菌检查 薄膜过滤法 

分 类 号：R944.1[医药卫生—药剂学] R986[医药卫生—药学]