摘要
目的:微生物限度检查是药物安全性研究的重要组成部分,建立常规检查法检查黄柏片的微生物限度,并验证方法。方法:依据《中国药典》2020年版四部,建立需氧菌总数、霉菌和酵母菌控制菌检查方法。结果:进行3次独立的平行试验,阳性菌的回收率试验结果在0.5~2.0之间,符合验证要求。需氧菌总数、霉菌和酵母菌总数采用平皿法;控制菌采用常规法。结论:建立的方法适用于检查黄柏片的微生物。
Objective:Microbial limit test is an important part of drug safety research.Establish a routine test method to check the microbial limit of phellodendri tablets,and verify the method.Methods:According to the "Pharmacopoeia of the People’s Republic of China",established a method for detecting the total number of aerobe,mold and yeast,and the control bacteria.Results:After three independent parallel tests,the recovery rate of positive bacteria was between 0.5 and 2.0,which met the verification requirements.The total number of aerobic bacteria,molds and yeasts shall be determined by plate method;routine method was used to control bacteria.Conclusion:The method is suitable for the examination of microorganisms in phellodendri tablets.
作者
郭文芬
谢作桦
王爱贵
GUO Wenfen;XIE Zuohua;WANG Aigui(Jiangxi Provincial Drug Certification and Evaluation Center,Nanchang Jiangxi 330002,China;Jiangxi Deshang Medical Research Institute Co.,LTD.,Zhangshu Jiangxi 331208,China;Jiangxi Deshang Pharmaceutical Co.,Ltd.Research Institute,Zhangshu Jiangxi 331208,China.)
出处
《药品评价》
CAS
2021年第22期1375-1377,共3页
Drug Evaluation
关键词
黄柏片
微生物限度检查
计数方法适用性试验
平皿法
Phellodendri tablets
Microbial limit test
Suitability test of counting method
Plate method
