| 阿奇霉素滴眼液微生物限度检查方法的验证 |
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| 引用本文： | 李秋菲,张芹.阿奇霉素滴眼液微生物限度检查方法的验证[J].安徽医药,2009,13(12):1493-1494. |
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| 作者姓名： | 李秋菲 张芹 |
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| 作者单位： | 陕西省食品药品检验所;陕西省医疗器械检测中心,陕西西,安,710061 |
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| 摘 要： | 目的建立阿奇霉素滴眼液微生物限度检查方法。并对方法进行验证。方法按中国药典2005年版二部所载滴眼剂项下要求进行试验。采用薄膜过滤法,冲洗量细菌为300 m l,霉菌和酵母菌为300 m l。结果样品管无菌生长,六株阳性对照菌生长良好。结论采用薄膜过滤法验证试验进行阿奇霉素滴眼液微生物限度检查,方法有效可行。
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| 关 键 词： | 阿奇霉素滴眼液 微生物限度检查法(薄膜过滤法) 方法验证 |
Sterility test of compound azithromycin for injection |
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| LI Qiu-fei,ZHANG Qing.Sterility test of compound azithromycin for injection[J].Anhui Medical and Pharmaceutical Journal,2009,13(12):1493-1494. |
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| Authors: | LI Qiu-fei ZHANG Qing |
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| Institution: | LI Qiu-fei1,ZHANG Qing2 (1.Shannxi Institute of Food , Pharmacy Control,Xi\'an,Shannxi 710061,2.Shannxi Center For Medical Devices Testing,Shannxi 710061) |
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| Abstract: | Aim To provide a method of the microbial limit test for azithromycin eye drops and carry out the verification of the method. Method The test method was carried out according to the method in Volume eye drops of II Chinese Pharmacopoeia Edition 2005. Centrifuging and filtering method was used . Results The membrane filteration was used in the microbial limit test for azithromyein eye drops. A aspergllus niger was used as positive control gems and the total amount of irrigation fluid was 300 ml. Conclusion It was proved that the method was effective and reliable, and it can be used for the microbial limit test for azithromvcin eve droos. |
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| Keywords: | azithromycin eye drops microbial limit test method validation tests |
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