| 甲硝唑注射液无菌检查方法学验证研究 |
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| 引用本文： | 李玲,宋碧婵.甲硝唑注射液无菌检查方法学验证研究[J].中小企业科技,2011(2):22-24. |
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| 作者姓名： | 李玲 宋碧婵 |
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| 作者单位： | 广西南宁百会药业集团有限公司,广西南宁530003 |
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| 摘 要： | 文章主要探讨建立甲硝唑注射液的无菌检查方法。本试验取甲硝唑注射液,按《中国药典》2005年版二部附录所载的＂无菌检查法＂进行方法学验证试验。结果表明：采用本试验方法Ⅲ进行甲硝唑注射液的无菌检查,供试品无菌生长,而6株阳性菌生长良好,方法可行。
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| 关 键 词： | 甲硝唑注射液 无菌检查法（薄膜过滤法） 方法学验证 |
A Study on the Methodology of the Testing Sterility Method on Metronidazole Injection |
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| Authors: | LI Ling SONG Bi-chan |
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| Institution: | (Guangxi Nanning Baihui Pharmaceuticals Group Co.,Ltd.,Nanning Guangxi 530003) |
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| Abstract: | The article mainly elaborates the testing sterihty method on metronidazole Injection.This test method gets metronidazole injection,and examines its methodology,based on the sterility testing methods recorded in Chinese Pharmacopeia,Edition 2005,the volumeⅡAppendix.The results shows that applying this testing methodⅢto carry sterility test on metronidazole injection and make the test objects grow in sterility,and all of six strains positive control tubes reveal the growth of microorganism that proves this method is feasible. |
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| Keywords: | metronidazole injection sterility testing methods methodology |
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