安神补心制剂的微生物限度检查及微生物的鉴定  

Microbial Limit Test and Microorganism Identification of Anshenbuxin Preparations

作　　者：李芳[1] 冯震[1] 刘冬玲[1] 刘浩[1] 杨美成[1] LI Fang;FENG Zhen;LIU Dongling;LIU Hao;YANG Meicheng(Shanghai Institute for Food and Drug Control,Shanghai 201203)

机构地区：[1]上海市食品药品检验所,上海201203

出　　处：《中国医药工业杂志》2018年第12期1705-1709,共5页Chinese Journal of Pharmaceuticals

基　　金：2015年国家药品抽验计划完善标准专题(食药监办药化监[2015]82号)

摘　　要：建立安神补心制剂的微生物限度检查方法,对25家生产企业193件产品的微生物限度检查结果进行分析,并对检出微生物进行分离和鉴定。细菌计数采用中和稀释法,霉菌和酵母菌计数、大肠埃希菌采用中和法,沙门菌采用常规法。收集整理检出的微生物37株,利用革兰染色镜检、生化鉴定和RiboPrinter核糖体分型等方法进行菌种鉴定。193件产品微生物检查的合格率为100%,但都有不同程度的微生物污染,主要污染物为枯草芽孢杆菌、巨大芽孢杆菌、地衣芽孢杆菌和蜡样芽孢杆菌。中药制剂的微生物学质量分析应包括对检出微生物的分离、鉴定和分析,有助于产品的质量控制和过程监管。The microbial limit test method of Anshenbuxin preparations was established,and the test results of 193 products from 25 manufacturers were analyzed.Furthermore,certain contaminant bacteria of some batches were separated,isolated and identified.Bacterial counts were determined by neutralization dilution method,mold and yeast counts using neutralization method,as well as detection of Escherichia coli.The conventional methods were used for detection of Salmonella.A total of 37 microorganisms were collected,and the strains were identified by Gram stain, biochemical identification and RiboPrinter ribosome typing.The pass rate of microbial examination of 193 products was 100%.But there were different levels of microbial contamination.The main pollutants were Bacillus subtilis,Bacillus megaterium,Bacillus licheniformis and Bacillus cereus.The microbiological quality analysis of traditional Chinese medicine preparations should include the separation,identification and analysis of the detected microorganisms,which contributes to the quality control and process supervision of the products.

关 键 词：安神补心制剂 微生物限度检查 污染菌 分离鉴定 

分 类 号：Q93[生物学—微生物学]