医院制剂水合氯醛口服溶液微生物限度检查方法的建立  

Establishment of microbial limit test for Chloral Hydrate Oral Solution of hospital preparations

作　　者：曾蔚欣 刘敏 刘俊丽 田佳懿 ZENG Weixin;LIU Min;LIU Junli;TIAN Jiayi(Department of Pharmacy, Beijing Shijitan Hospital, Capital Medical University, Beijing 100038, China)

机构地区：[1]首都医科大学附属北京世纪坛医院药剂科

出　　处：《中国医药导报》2019年第15期96-99,共4页China Medical Herald

基　　金：首都卫生发展科研专项项目(首发2011-2008-01)

摘　　要：目的建立有效、简单、经济的医院制剂水合氯醛口服溶液微生物限度检查方法,并用建立的方法对3个批次的样品进行微生物限度检查。方法依据现行《中国药典》2015年版四部通则的相关要求,选用薄膜过滤法进行样品的前处理,选用5种菌株进行方法学验证。结果微生物计数检查的5种菌种的回收率均在0.5~2.0范围内,控制菌检查大肠埃希菌合格。结论水合氯醛口服溶液的微生物限度检查方法经验证符合2015年版《中国药典》的要求。Objective To establish an effective, simple and economical microbial limit test method for Chloral Hydrate Oral Solution of hospital preparations, which was used to carry out microbial limit test for three batches of samples. Methods According to the related requirement of the four general rules of the 2015 edition of Chinese Pharmacopoeia, membrane filtration was used for sample pretreatment. 5 strains were selected for methodological verification. Results The recovery ratio of the five strains of microbial counts were within the range of 0.5 to 2.0, and Escherichia coli tested by control bacteria was qualified. Conclusion After verification, the microbial limit test for Chloral Hydrate Oral Solution can meet the requirements of the 2015 edition of Chinese Pharmacopoeia.

关 键 词：水合氯醛口服溶液 薄膜过滤法 微生物限度检查 方法学验证 中国药典2015年版 

分 类 号：R927.33[医药卫生—药学]