| 盐酸左氧氟沙星片微生物限度检测的方法学建立和验证 |
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| 引用本文： | 李趣嫦,朱欢敏,肖建光. 盐酸左氧氟沙星片微生物限度检测的方法学建立和验证[J]. 中国药物经济学, 2014, 0(5): 16-17 |
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| 作者姓名： | 李趣嫦 朱欢敏 肖建光 |
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| 作者单位： | 广东省食品药品检验所微生物室,广东广州510180 |
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| 摘 要： | 目的建立了盐酸左氧氟沙星片微生物限度的检测方法,并对方法学进行验证。方法采用低速离心结合薄膜过滤手段建立盐酸左氧氟沙星片的微生物限度检测方法。结果细菌计数及控制菌用薄膜过滤法检查,霉菌及酵母菌计数用常规法检查。结论该方法准确、可靠,适用于左氧氟沙星片的微生物检查。
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| 关 键 词： | 左氧氟沙星片 微生物限度 方法学 建立 验证 |
Development and Validation of a Microbial Limit test Method for Levofloxacin Hydrochloride tablets |
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| Li Quchang,Zhu Huanmin,Xiao Jianguang. Development and Validation of a Microbial Limit test Method for Levofloxacin Hydrochloride tablets[J]. China Journal of Pharmaceutical Economics, 2014, 0(5): 16-17 |
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| Authors: | Li Quchang Zhu Huanmin Xiao Jianguang |
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| Affiliation: | Li Quchang, Zhu Huanmin, Xiao Jianguang |
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| Abstract: | Objective To develop and validate a method for microbial limit detection of levofloxacin hydrochloride tablets.Methods Low-speed centrifugation and membrane filtration approaches were used for the development of microbial limit detection method for levofloxacin hydrochloride tablets.Results The bacteriad and the control of bacteria were determined by membrane filtration approach,molds and yeast were determined by routine approach. Conclusion The method is accurate,reliable,and suitable for detection of the microbial limit of levofloxacin hydrochloride tablets. |
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| Keywords: | Levofloxacin tablets Microbial limit detection Method Development Validation |
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