注射用头孢米诺钠无菌检查方法的验证 |
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引用本文: | 何利群,赵海英. 注射用头孢米诺钠无菌检查方法的验证[J]. 黑龙江医药, 2010, 23(5): 714-716 |
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作者姓名: | 何利群 赵海英 |
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作者单位: | 哈尔滨誉衡药业股份有限公司,150025;哈尔滨誉衡药业股份有限公司,150025 |
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摘 要: | 目的:建立注射用头孢米诺钠无菌检查方法。方法:参照中国药典2005年版二部附录XIH进行试验。结果:采用薄膜过滤法,以0.1%无菌蛋白胨水溶液为冲洗液,选择冲洗量为500ml,即可消除样品对各菌株的抗菌活性。结论:故注射用头孢米诺钠可按照此方法进行无菌检查。
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关 键 词: | 注射用头孢米诺钠 无菌检查 薄膜过滤法 |
Sterility Test Method Validation of Cefminox Sodium for Injection |
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Affiliation: | He Liqun,et al Harbin Gloria Pharmaceuticals Co.,Ltd(Harbin 150025) |
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Abstract: | Objective:To establish a Sterility test method of Cefminox Sodium for Injection.Methods:To test according to Chinese pharmacopoeia 2005 edition appendix XIH.Results:The antibacterial activity of various sample strains can be eliminated with membrane filtration method,500ml 0.1% sterile peptone aqueous solution as flushing fliud.Conclusion:This method can be used as the sterility test method for Cefminox Sodium for Injection. |
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Keywords: | Cefminox Sodium for Injection sterility test membrane filtration method |
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