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芪参清幽胶囊微生物限度检查方法验证

刘元昆 张立贤

中国执业药师Issue(1):30-33,4.
中国执业药师Issue(1):30-33,4.DOI:10.3969/j.issn.1672-5433.2015.01.007

芪参清幽胶囊微生物限度检查方法验证

Research on the Method Validation of Microbial Limit Test for Qishenqingyou Capsules

刘元昆 1张立贤2

作者信息

  • 1. 威海市中医院,山东 威海 264200
  • 2. 威海市经区医院
  • 折叠

摘要

Abstract

Objective:To establish a method of microbial limit test for qishenqingyou capsules . Methods:Ac-cording to the Chinese Pharmacopoeia of 2010 edition , the method validation of microbial limit test on qishenqingy-ou capsules was conducted . Results: By using the conventional test methods , the antibacterial actions of qishen-qingyou capsules were showed for Bacillus subtilis and Staphylococcus aureus , and the recovery rate was less than 70%. The culture medium dilution method could eliminate the antibacterial activity of the product for the above two strains , and the recovery rate was greater than 70%. The conventional test methods can detect Escherichia coli in the product . Conclusion:For the product , the conventional test methods can be used for the bacterial counting test of mould or yeast and the control tests of bacteria , and the dilution method can be used for determination of bacte-ria .

关键词

芪参清幽胶囊/微生物限度/方法验证

Key words

Qishenqingyou Capsules/Microbial Limit/Method Validation

引用本文复制引用

刘元昆,张立贤..芪参清幽胶囊微生物限度检查方法验证[J].中国执业药师,2015,(1):30-33,4.

中国执业药师

2096-3327

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