复方瓜子金颗粒微生物限度检查方法适用性研究  

Study on Microbial Limit Suitability Test Method of Compound Guazijin Granules

作　　者：陈希 刘绪平 储梅君 张银花 段和祥 

机构地区：[1]江西省药品检验检测研究院江西省药品与医疗器械质量工程技术研究中心,江西南昌330029

出　　处：《今日药学》2017年第10期655-657,共3页Pharmacy Today

基　　金：江西省食品药品监督管理局科研项目(2016YP18)

摘　　要：目的建立适用于4家企业的复方瓜子金颗粒微生物限度检查方法。方法按照中国药典2015年版微生物计数法(1105)和平皿倾注法(1∶10供试液),大肠埃希菌检查采用常规法。结果各试验菌的回收比值均符合药典规定,且控制菌检查试验组检出大肠埃希菌,阴性对照组未检出大肠埃希菌。结论该方法可用于4家企业的复方瓜子金颗粒微生物限度的检查。OBJECTIVE To establish a microbial limit test method for compound Guazijin granules by four companies. METHODS According to Chinese Pharmacopoeia 2015 method, microbiological count was checked by pour plate count method （ 1：10 solution）. Escherichia coli was checked by the general method. RESULTS The recovery ratios of all the tested strains were in accordance with Chinese Pharmacopoeia 2015. Escherichia coli was detected in the experimental group, and it was not detected in the negative control group. CONCLUSION The method is suitable for the microbial limit test of compound Guazijin granules by four companies.

关 键 词：复方瓜子金颗粒 微生物限度 方法适用性 

分 类 号：R284.1[医药卫生—中药学]