| 加替沙星注射液无菌检查方法的验证 |
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| 引用本文： | 张国林,沈海英,顾炳仁.加替沙星注射液无菌检查方法的验证[J].现代生物医学进展,2014,14(30):5980-5982. |
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| 作者姓名： | 张国林 沈海英 顾炳仁 |
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| 作者单位： | 苏州市食品药品检验所;苏州大学 |
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| 摘 要： | 目的:建立加替沙星注射液无菌检查方法。方法:根据《中国药典》2010年版二部附录XIH无菌检查法验证试验指导原则,采用薄膜过滤法和添加硫酸锰中和剂去除加替沙星抑菌活性的实验方法和条件进行了验证,建立了加替沙星注射液无菌检查的方法。结果:采用薄膜过滤法用pH7.0无菌氯化钠-蛋白胨缓冲液进行冲洗,每桶5×100mL的冲洗量,每桶(100mL)培养基中加入硫酸锰溶液可去除加替沙星对各菌株的抑菌作用。结论:加替沙星注射液的无菌检查可采用上述方法。
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| 关 键 词： | 加替沙星 无菌检查 薄膜过滤法 硫酸锰 |
The Validation of Sterility Test Method
for Gatifloxacin Injection |
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| ZHANG Guo-lin,SHEN Hai-ying,GU Bing-ren.The Validation of Sterility Test Method
for Gatifloxacin Injection[J].Progress in Modern Biomedicine,2014,14(30):5980-5982. |
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| Authors: | ZHANG Guo-lin SHEN Hai-ying GU Bing-ren |
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| Institution: | ZHANG Guo-lin;SHEN Hai-ying;GU Bing-ren;Suzhou Institute for Food and Drug Control;Suzhou University; |
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| Abstract: | Objective:To establish the sterility test method of gatifloxacin injection.Methods:We adopted membrane-filter
procedure and added neutralizer MnSO4 by controlling the antibacterial activity according to the Chinese Pharmacopeia (2010 edition).Results:The antibacterial activity of gatifloxacin injection was abolished by wash the filter by pH7.0 Sodium Chloride-Peptone buffer for
5 times (100 mL per time).Conclusion:The aforementioned method can be used of the sterility detection of gatifloxacin injection. |
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| Keywords: | Gatifloxacin injection Sterility test Membrane filtration MnSO4 |
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