摘要
目的建立阿奇霉素胶囊微生物限度检查法并进行方法学验证。方法按《中国药典》2015年版四部制剂通则1105、1106、1107项下要求进行试验。霉菌和酵母菌检查采用平皿法,需氧菌总数检查采用薄膜过滤法,大肠埃希菌检查采用薄膜过滤法,采用上述方法对阿奇霉素胶囊各试验菌进行回收试验测试及对控制菌检查方法进行验证。结果需氧菌总数、霉菌和酵母菌总数验证试验中各菌的回收比值均符合《中国药典》2015年版规定,控制菌检查方法可行。结论该方法适用于阿奇霉素胶囊的微生物限度检查。
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.
出处
《中国医药科学》
2016年第17期37-39,共3页
China Medicine And Pharmacy
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
Azithromcin capsule
Microbial limit test
Pour plate method
Membrane filtration Method
Method validation
