清开灵片微生物限度检查方法学验证

Validation Method Used for Microbial Limits of Qingkailing Tablets

目的:确定清开灵片微生物限度的检查条件和方法,确保其检查方法的科学性和检验结果的准确性。方法:采用2005年版《中国药典》(一部)附录"微生物限度检查法"项下相关内容进行方法学验证。结果:确定薄膜过滤法作为清开灵片微生物限度的检查方法。结论:本试验为清开灵片微生物限度检查提供了方法学依据,对药品的生产及检验有较大的实用价值。

Objective： To determine the conditions and methods of inspection of Qinkailing tablets microbial limit to ensure that its examination of scientific and the accuracy of the test results.Methods： Transfer the sample about 1ml,equvalent to about 2mg of Monoammonium Glycyrrhizinate,add 1 ml of 20% The 2005 version of ＂Chinese Pharmacopoeia＂ （1） Appendix ＂microbial limits test＂ under relevant content verification methodology.Results： The film filtration identified as a tablet-microbial limit the examination. Conclusion： The pilot for a tablet-microbial limit inspection methodology provides a basis for the production of drugs and tests have more practical value.