医院制剂上感合剂微生物限度检查方法建立  

Establishment of Microbial Limit Test Method for Shanggan Mixture of Hospital Preparations

作　　者：赵婷[1] 曾博雅 马佩杰[1] 卢俊玮 舒文将 强羽菲 鞠依珊 Zhao Ting;Zeng Boya;Ma Peijie;Lu Junwei;Shu Wenjiang;Qiang Yufei;Ju Yishan(Baoji Certral Hospital,Baoji 721008,Shanxi,China;Baoji Food and Drug Inspection and Testing Center,Baoji 721013,Shanxi,China)

机构地区：[1]宝鸡市中心医院,陕西宝鸡721008 [2]宝鸡市食品药品检验检测中心,陕西宝鸡721013

出　　处：《贵州医药》2023年第10期1522-1524,共3页Guizhou Medical Journal

摘　　要：目的建立简单、有效的医院制剂上感合剂微生物限度检查的方法。方法根据2015年版《中国药典》四部通则规定的方法对该制剂的微生物限度检查方法学进行验证。结果微生物计数检查的5种菌株回收率在0.5~2范围内,控制菌检查大肠埃希菌合格。结论建立的方法准确可行,可用于医院制剂上感合剂的微生物限度检查。Objective To establish an simple,effective method for the microbial limit test of Shanggan mixture of hospital preparations.Methods According to the method of Chinese Pharmacopoeia(2015 edition,Ⅳ),the microbial limit test of Shanggan mixture of hospital preparations was studied.Results The recovery ratio of the five strains of microbial counts were within the range of 0.5 to 2,and Escherichia coli tested by control bacteria were qualified.Conclusion The established method is correct and suitable,which can be used for the microbial limit test of Shanggan mixture of hospital preparations.

关 键 词：上感合剂 2015版《中国药典》 微生物限度检查 方法学验证 回收率 

分 类 号：R97[医药卫生—药品]