肠炎宁片2015年版药典微生物限度检查法验证与评价  

Verification and Evaluation on Microbial Limit Test of Methodology for Changyanning Tablets in ChP 2015

作　　者：刘绪平 张文婷 易路遥 熊骏 张春华 肖春[2] 

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,南昌330029 [2]江西省人民医院药剂科

出　　处：《中国药师》2017年第5期946-948,共3页China Pharmacist

摘　　要：目的:建立肠炎宁片微生物限度检查方法,并对方法进行验证和评价。方法:需氧菌总数计数法及霉菌和酵母菌总数计数法均采用平皿法,供试液浓度分别为1∶100和1∶10。大肠埃希菌检查、耐胆盐革兰阴性菌检查和沙门菌检查均为常规法。结果:5种试验菌的回收试验结果均在0.5~2.0之间。结论:该方法适用于肠炎宁片的微生物限度检查。Objective： To provide a method of microbial limit test for Changyanning tablets and carry out the verification of the mothod. Methods： A plate method was used in the total aerobic microbial count and the concentration of the test liquid was 1 ： 100. A plate method was used in the total yeast and mold count while the concentration of the test liquid was 1 ： 10. The direct inoculation method was used for the detection of Escherichia coli, bile-tolerant gram -negative bacteria and Salmonella enterica subsp. Results： The recoveries of the five strains were from 0.5 to 2.0. Conclusion： The method is suitable for the microbial limit examination of Changyanning tablets.

关 键 词：肠炎宁片 微生物限度检查 方法验证 

分 类 号：R927.11[医药卫生—药学]