摘要
目的建立复方黄连素片微生物限度检查法。方法按照《中华人民共和国药典》2020年版四部规定,采用平皿倾注法、降低检品供试液浓度法、降低检品供试液浓度联合薄膜过滤法等办法依次进行微生物限度检查方法的适用性实验。结果需氧菌计数采用薄膜过滤法,霉菌和酵母菌计数采用降低检品供试液浓度的方法,药品标准规定必须检查的三种控制菌采用常规浓度直接接种法。结论本实验拟定的检查方法步骤简单、花费时间短。
Objective To establish the method of microbial limit test of Fufang Huangliansu tablets.Methods According to the provisions of Part Four of the 2020 edition of the Pharmacopoeia of the People's Republic of China,the applicability test of microbial limit testing methods shall be gradually carried out using methods such as plate pouring method,increasing dilution ratio,and dilution combined with membrane filtration.Results The membrane filtration method was used for aerobic bacteria counting.The medium dilution method was used for counting total combined molds and yeasts.The direct inoculation method was used for three types of control bacteria that must be tested according to drug standards.Conclusion The microbiological limit test method for this drug proposed in this experiment is simple and easy to implement.
作者
陈隽
CHEN Jun(Nantong Food and Drug Supervision and Inspection Center,Nantong 226006,China)
出处
《实验室检测》
2024年第4期24-27,共4页
Laboratory Testing
关键词
复方黄连素片
微生物限度
方法验证
平皿倾注法
薄膜过滤法
Fufang Huangliansu tablets
microbial limit
validation of method
plate pouring method
membrane filtration method
作者简介
通信作者:陈隽,主管药师,研究方向为中西药品监督检验检测。E-mail:584105425@qq.com
