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安坤种子丸微生物限度检查法的建立及方法学验证

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《西部中医药》[ISSN:2096-9600/CN:62-1204/R]

Title:: Establishment and Methodology Verification of Microbial Limit Test for AnKun ZhongZiWan

作者:: 张小华1，何晓英2，刘效栓1，胡君茹3，马琴国1; 1 甘肃省中医院，甘肃兰州 730050； 2 甘肃省食品药品检验所； 3 甘肃省中医药研究院

Author(s):: ZHANG Xiaohua1, HE Xiaoying2, LIU Xiaoshuan1, HU Junru3, MA Qin′guo1; 1 Gansu Provincial Hospital of Traditional Chinese Medicine, Lanzhou 730050, China; 2 Gansu Food and Drug Administration; 3 Gansu Provincial Hospital of Traditional Chinese Medicine

摘要:: 目的：建立安坤种子丸微生物限度检查的方法并进行验证。方法：按2010年版《中华人民共和国药典》，用大肠埃希菌、枯草芽胞杆菌、金黄色葡萄球菌、黑曲霉菌和白色念珠菌对安坤种子丸进行微生物限度检查法的方法学验证试验。结果：安坤种子丸对细菌中的大肠埃希菌、金黄色葡萄球菌、枯草芽孢杆菌有一定程度的抑制作用，可通过稀释法消除抑菌作用。结论：安坤种子丸对细菌的计数方法采用培养基稀释法(0.2 mL/皿)进行测定，霉菌、酵母菌可采用常规法测定，控制菌检查可采用常规法进行大肠埃希菌和大肠菌群的检验。该方法用于安坤种子丸的质量控制有效可行。

Abstract:: Objective: To establish microbial limit test for AnKun ZhongZiWan and validate the method. Method: Escherichia coli, Bacillu Subtilis, Staphy lococcus aureus, Aspergillus niger and Candida albicans were taken as the indexes, microbial limit test for AnKun ZhongZiWan was performed according to Chinese Pharmacopoeia of 2010 version. Result: AnKun ZhongZiWan could inhibit Escherichia coli, Bacillu Subtilis and Staphylococcus aureus to a certain extent, and bacteriostasic activity could be removed by dilution method. Conclusion: Media dilution method (0.2 mL/media) could be used for the tests of bacteria, filamentous fungi and yeasts were detected with routine method, Escherichia coli and coliform could be tested by routine method in bacterial control examination. The method is practicable and could be used for quality control for AnKun ZhongZiWan.

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更新日期/Last Update: 2013-11-15