| 注射用甲磺酸加贝酯无菌检查方法的验证 |
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| 引用本文： | 何利群,赵海霞. 注射用甲磺酸加贝酯无菌检查方法的验证[J]. 黑龙江医药, 2010, 23(6): 922-924 |
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| 作者姓名： | 何利群 赵海霞 |
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| 作者单位： | 哈尔滨誉衡药业股份有限公司,150025 |
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| 摘 要： | 目的：建立注射用甲磺酸加贝酯无菌检查方法。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300ml,即可消除样品对各菌株的抑菌活性。结论：故注射用甲磺酸加贝酯可按照此方法进行无菌检查。
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| 关 键 词： | 注射用甲磺酸加贝酯 无菌检查 薄膜过滤法 |
Sterility Test Method Validation of Gabexate Mesylate for Injection |
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| Affiliation: | He Liqun, et al( Harbin Gloria Pharmaceuticals Co. ,Ltd Harbin 150025) |
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| Abstract: | Objectlve：To establish a Sterility test method of Cabexate Mesylate 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 ,300ml 0. 1% sterile peptone aqueous solution as flushing fliud. Conclusion：This method can be used as the sterility test method for Gabexate Mesylate for Injection. |
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| Keywords: | Gabexate Mesylate for Injection sterility test membrane filtration method |
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