中国医药科学2016，Vol.6Issue(17)：37-39,3.
阿奇霉素胶囊新版药典微生物限度检查方法的建立
Establishment of microbial limit test method for Azithromcin Capsule Chinese Pharmacopoeia 2015
刘绪平 1肖钦钦 1陈希 1张春华 1李景莲2
作者信息
- 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
- 2. 南京军区南昌药品器材供应站，江西南昌 330029
- 折叠
摘要
Abstract
Objective To establish a method of microbial limit test for Azithromcin Capsule. Methods According to 1105, 1106, 1107 of Chinese Pharmacopoeia 2015 method, total combined yeasts and molds count were checked by plate count (1:10 solution), total aerobic microbial count was checked by membrane filtration method, and escherichia coli was checked by membrane filtration method. Results Recovery ratio of each test bacteria was in line with Chinese Pharmacopoeia 2015. Escherichia coli could be detected in the positive control. Conclusion This method can be used for microbial limit test for Azithromcin Capsules.关键词
阿奇霉素胶囊/微生物限度/平皿法/薄膜过滤法/方法学验证Key words
Azithromcin capsule/Microbial limit test/Pour plate method/Membrane filtration Method/Method validation分类
医药卫生引用本文复制引用
刘绪平,肖钦钦,陈希,张春华,李景莲..阿奇霉素胶囊新版药典微生物限度检查方法的建立[J].中国医药科学,2016,6(17):37-39,3.
