于氏解郁调肝散微生物限度检测方法考察
Study on Microbial Limit Test Method of Yushi Jieyutiaogan Powder
梁林辉 1章斌 1芦珂 1姚永秀 1何露2
作者信息
- 1. 雅安职业技术学院, 药学与检验学院, 雅安市食品药品应用开发工程技术研究中心, 四川 雅安 625000
- 2. 华润三九 (雅安) 药业有限公司, 四川 雅安 625000
- 折叠
摘要
(目的)建立于氏解郁调肝散的微生物限度检测方法,加强于氏解郁调肝散的质量控制.(方法)依据2020 版《中国药典》中非无菌制剂微生物限度检测法进行方法适用性考察.(结果)采用1∶1000 稀释法测定需氧菌总数,采用1∶10 稀释法测定霉菌和酵母菌总数,各实验菌回收率在0.5～2 之间;三种控制菌大肠埃希菌、沙门菌、耐胆盐革兰阴性菌均可采用常规接种法,结果符合要求.(结论)研究建立的微生物限度检测方法,准确、重复性好,可用于于氏解郁调肝散的质量控制,为完善于氏解郁调肝散的质量标准提供了重要数据支持.
Abstract
Objective:To establish the microbial limit test method of Yushi Jieyutiaogan powder and enhance the quality controllability of Yushi JieYutiaogan powder.Methods:Using the microbial limit test method of non-sterile preparation in 2020 edition of Chinese Pharmacopoeia to in-vestigate method applicability.Results:The total number of aerobic bacteria was determinedby1∶1000 dilution method,and the total number of mold and yeast counts were determinedby 1∶10 dilution method,the recovery rates of each experimental bacteria were in the range of 0.5 and 2;Three control bacteria,Escherichia coli,Salmonella and bile salt tolerant gram negative bacteria were all tested using routine methods.The results meet the requirements.Conclusion:The microbial limit test method established in this study for Yushi Jieyutiaogan powder is accurate and repro-ducibility.It can be used to evaluate the quality of Yushi Jieyutiaogan powder.This paper can provide important data for establishing the quality standards of Yushi Jieyutiaogan powder.
关键词
于氏解郁调肝散/微生物限度/平皿法Key words
Yushi jieyutiaogan powder/microbial limit test method/quality control引用本文复制引用
基金项目
雅安市省级转移支付项目(2021)(22ZYZF0003)
雅安职业技术学院高层次人才中药制剂研究工作室科研项目(Yzygcky202219)
出版年
2024
国家科技期刊平台
NSTL
万方数据