| 注射用头孢尼西钠无菌检查方法学研究 |
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| 引用本文： | 李冰,赵颖,文毅. 注射用头孢尼西钠无菌检查方法学研究[J]. 中国药事, 2009, 23(1) |
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| 作者姓名： | 李冰 赵颖 文毅 |
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| 作者单位： | 1. 辽宁省食品药品检验所,沈阳,110023
2. 上海普康药业有限公司 |
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| 摘 要： | 目的 建立注射用头孢尼西钠的无菌检查方法.方法 采用薄膜过滤+酶法对样品进行无菌检查.结果 注射用头孢尼西钠具有较强的抑菌活性,对不同验证菌株的敏感性显著不同.结论薄膜过滤+酶法能有效的去除其抑菌性,并通过验证试验保证无菌检查方法的可靠性.
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| 关 键 词： | 注射用头孢尼西钠 无菌检查法 方法验证 |
Studies on Test for Sterility of Cefonicidum Natricum for Injection |
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| Li Bing,Zhao Ying,Wen Yi. Studies on Test for Sterility of Cefonicidum Natricum for Injection[J]. Chinese Pharmaceutical Affairs, 2009, 23(1) |
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| Authors: | Li Bing Zhao Ying Wen Yi |
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| Affiliation: | Li Bing,Zhao Ying1 and Wen Yi |
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| Abstract: | Objective To establish a methods for determining sterility test of Cefonicidum Natricum for Injection.Methods The membrane filtrating and enzyme methods were used.Results It had higher antimicrobial effects.There were dramatically different antibacterial sensitivities to the validating bacteria among the generations of cefonicidum natricum due to their different antibiotics profiles.Conclutions Membrane filtrating and enzyme methods have higher antimicrobial effect,meanwhile the validity of sterility test for the Cefonicidum Natricum for Injections is assured. |
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| Keywords: | Cefonicidum Natricum for Injection test for sterility method validation tests |
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