首页|于氏解郁调肝散微生物限度检测方法考察

于氏解郁调肝散微生物限度检测方法考察

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(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.
Study on Microbial Limit Test Method of Yushi Jieyutiaogan Powder
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.

Yushi jieyutiaogan powdermicrobial limit test methodquality control

梁林辉、章斌、芦珂、姚永秀、何露

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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

华润三九 (雅安) 药业有限公司, 四川 雅安 625000

于氏解郁调肝散 微生物限度 平皿法

雅安市省级转移支付项目(2021)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

22ZYZF0003Yzygcky202219

2024

云南化工
云南省化工研究院 云天化集团有限责任公司 云南煤化工集团有限公司 云南省化学化工学会

云南化工

影响因子:0.272
ISSN:1004-275X
年,卷(期):2024.51(3)
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