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

(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。

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 investigate method applicability.Results:The total number of aerobic bacteria was determinedby 1∶[KG-3/5]1000 dilution method,and the total number of mold and yeast counts were determinedby 1∶[KG-3/5]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 reproducibility.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.