复方黄连素片微生物限度检查方法的研究
Study on microbial limit test for Fufang Huangliansu tablets
陈隽1
作者信息
- 1. 南通市食品药品监督检验中心,南通 226006
- 折叠
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.
Abstract
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.
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Key words
Fufang Huangliansu tablets/microbial limit/validation of method/plate pouring method/membrane filtration method引用本文复制引用
出版年
2024
NETL
NSTL
万方数据