清开灵片微生物限度检查方法学验证 |
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引用本文: | 刘影,贾瑞艳.清开灵片微生物限度检查方法学验证[J].黑龙江医药,2009,22(3):277-279. |
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作者姓名: | 刘影 贾瑞艳 |
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作者单位: | 哈尔滨圣泰制药股份有限公司,150025 |
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摘 要: | 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。
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关 键 词: | 清开灵片 微生物限度检查法 薄膜过滤法 |
Validation Method Used for Microbial Limits of Qingkailing Tablets |
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Institution: | Liu Ying , et al (Harbin ShengtaiPharmaceutical Co.,lid, (150025) |
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Abstract: | 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. |
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Keywords: | Qinkailing tablets microbial limits test film filtration |
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