加味消毒饮颗粒微生物限度检查方法学验证  

Validation of microbial limit test method of Jiawei Xiaoduyin Granules

作　　者：刘钰[1] 吴无畏[1] 付书婕 蒋雅娜 王国倩 潘宇 陈路[1] LIU Yu;WU Wuwei;FU Shujie;JIANG Yana;WANG Guoqian;PAN Yu;CHEN Lu(Guangxi Zhuang Autonomous Region Medicinal Botanical Garden,Guangxi Zhuang Autonomous Region,Nanning530023,China;Department of Pharmacy,Guangxi Zhuang Yaofang Hospital,Guangxi Zhuang Autonomous Region,Nanning530150,China;Youjiang Medical University for Nationalities,Guangxi Zhuang Autonomous Region,Baise533000,China)

机构地区：[1]广西壮族自治区药用植物园,广西南宁530023 [2]广西壮要方医院药剂科,广西南宁530150 [3]右江民族医学院,广西百色533000

出　　处：《中国医药导报》2021年第36期103-106,共4页China Medical Herald

基　　金：国家自然科学基金资助项目(81960797);广西壮族自治区南宁市科学研究与技术开发计划项目(20203109)。

摘　　要：目的建立加味消毒饮颗粒的微生物限度检查方法。方法参考《中华人民共和国药典》标准,采用稀释法(1∶20)测定需氧菌总数,霉菌、酵母菌总数及控制菌(大肠埃希菌)的检测均采用常规法。结果需氧菌总数测定,回收率比值为0.98~1.03;霉菌和酵母菌总数测定,回收率比值为1.22~1.24;对于大肠埃希菌检查,供试品对照组均未检出阳性菌。结论所建立的方法可作为加味消毒饮颗粒微生物限度的检查方法。Objective To establish a microbial limit test method for Jiawei Xiaoduyin Granules.Methods According to the standard of Pharmacopoeia of the People’s Republic of China,the total number of aerobic bacteria was determined by dilution method(1∶20),and the total number of mold,yeast and control bacteria(Escherichia coli)were detected by conventional method.Results The recovery ratio of aerobic bacteria was 0.98-1.03.The total number of mold and yeast was determined,and the recovery ratio was 1.22-1.24.For Escherichia coli,no positive bacteria were detected in test samples and control group.Conclusion The established method can be used as a test method for microbe limit of Jiawei Xiaoduyin Granules.

关 键 词：加味消毒饮颗粒 稀释法 常规法 微生物限度检查 

分 类 号：R927.11[医药卫生—药学]