| 咳停合剂微生物限度检查法的建立与验证 |
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| 引用本文： | 杨征,陈雅,徐果. 咳停合剂微生物限度检查法的建立与验证[J]. 中国药业, 2014, 0(17): 34-35 |
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| 作者姓名： | 杨征 陈雅 徐果 |
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| 作者单位： | 中国人民解放军第三军医大学野战外科研究所大坪医院药剂科,重庆400042 |
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| 摘 要： | 目的：建立并验证咳停合剂的微生物限度检查方法。方法采用常规法、薄膜过滤法检查咳停合剂的微生物限度，并依据2010年版《中国药典（二部）》收载的方法进行验证。结果咳停合剂供试品试验菌株的回收率均高于70%，证明无抑菌现象。结论采用常规法与薄膜过滤法检查咳停合剂微生物限度均可行。
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| 关 键 词： | 咳停合剂 微生物限度检查 常规法 薄膜过滤法 验证 |
Establishment and Validation of Microbial Limit Test of Keting Mixture |
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| Yang Zheng,ChenYa,Xu Guo. Establishment and Validation of Microbial Limit Test of Keting Mixture[J]. China Pharmaceuticals, 2014, 0(17): 34-35 |
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| Authors: | Yang Zheng ChenYa Xu Guo |
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| Affiliation: | (Department of Pharmacy, Research Institute of Field Surgery, Daping Hospital, Third Military Medial University, Chongqing, China 400042) |
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| Abstract: | Objective To establish and validate a microbial limit test for Keting Mixture. Methods The conventional method and the membrane-filter procedure were adopted to detect the microbial limit of Keting Mixture and the validation was performed according to the method in the Chinese Pharmacopoeia （ version 2010, Part 2 ） . Results The recovery rate of experimental bacterial strain in Keting Mixture sample exceeded 70%, which proved that no bacteriostasis phenomena existed. Conclusion Adopting the conventional method and the membrane-filter procedure is feasible for detecting the microbial limit of Keting Mixture. |
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| Keywords: | Keting Mixture microbial limit test conventional method membrane-filter procedure validation |
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