11种药用淀粉及衍生物的微生物限度检查法适用性试验  

Suitability of microbial limit test methods for 11 kinds of medicinal starches and its derivatives

作　　者：李趣嫦[1] 李文靖[1] 张帆[1] LI Quchang;LI Wenjing;ZHANG Fan(Guangdong Institute for Drug Control,Guangzhou 510663,China)

机构地区：[1]广东省药品检验所

出　　处：《中国药品标准》2020年第1期56-61,共6页Drug Standards of China

摘　　要：目的:建立5种药用淀粉及其6种衍生物的微生物限度检查的方法适用性。方法:按照《中国药典》2015年版微生物限度检查法进行方法学的建立和验证,并对所研究的11种淀粉及衍生物样品中的微生物含量进行检测。结果:需氧菌总数及霉菌和酵母菌总数计数均可用平皿法检查,大肠埃希菌检查可用直接接种法检查。结论:淀粉及其衍生物一般无抑菌性,不同厂家生产的淀粉产品微生物含量有所差异,在选用时需考察。Objective:To establish the suitability of microbial limit test method for 5 kinds of medicinal starches and 6 derivatives.Methods:The microbial limit test methods were established and validated according to the Chinese Pharmacopoeia 2015.Then the microbial limits of 11 kinds of starches and derivatives were tested with the established methods.Results:The plate method was used for total counts of aerobic bacteria,and fungi and yeasts,and the direct inoculation method was used for Escherichia coli.Conclusion:The starches and derivatives have not bacteriostasis generally.The microbial contents present in starches produced by different manufacturers are different,and thus it is necessary to investigate it before selection.

关 键 词：辅料 淀粉 衍生物 微生物限度检查 

分 类 号：R921.2[医药卫生—药学]