| 甲硝唑葡萄糖注射液注射液无菌检查方法的验证 |
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| 引用本文： | 栾东晓,张彩霞.甲硝唑葡萄糖注射液注射液无菌检查方法的验证[J].中国对外贸易(英文版),2010(12). |
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| 作者姓名： | 栾东晓 张彩霞 |
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| 作者单位： | 哈药集团三精制药股份有限公司 |
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| 摘 要： | 目的 确定甲硝唑葡萄糖注射液的无菌检查方法.方法 按中国药典2005年版二部无菌检查法(附录XI H)中薄膜过滤法进行验证.结果 采用薄膜过滤法细菌以500ml/筒冲洗量、真菌以500ml/筒冲洗量检查,在规定条件下敏感菌可正常生长.结论 甲硝唑注射液的无菌检查可采用薄膜过滤法检查(500ml/筒冲洗量).
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| 关 键 词： | 甲硝唑葡萄糖注射液 无菌检查法 |
The validation for the asepsis check method of the metronidazole glucose injection |
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| Dongxiao Luan,Caixia Zhang.The validation for the asepsis check method of the metronidazole glucose injection[J].China's Foreign Trade,2010(12). |
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| Authors: | Dongxiao Luan Caixia Zhang |
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| Abstract: | The purpose: Determine the asepsis cheek method of the metronidazole glucose injection. The method: Validate according to Membrane filtration method in Chinese pharmacopoeia 2005 edition sterile test (appendix Ⅺ H).The result: Checking by using film filtration bacteria, Sensitive bacteria can be normal growth under prescribed conditions. The conclusion: The asepsis check of the metronidazole injection can be checked by Membrane filtration method (50Oml/cone flushing). |
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