| 十种外用医院制剂的微生物限度检查法验证 |
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| 引用本文： | 李湘平,李汶,徐文敏,莫金娜. 十种外用医院制剂的微生物限度检查法验证[J]. 中国药品标准, 2012, 13(4): 290-292 |
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| 作者姓名： | 李湘平 李汶 徐文敏 莫金娜 |
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| 作者单位： | 1. 汕头大学医学院第二附属医院,汕头,515041
2. 汕头市药品检验所,汕头,515041 |
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| 摘 要： | 目的:建立十种外用医院制剂的微生物限度检查方法。方法:采用平皿法、培养基稀释法、薄膜过滤法等对样品进行微生物限度检查,并按药典规定对所建立的方法进行验证。结果:采用适当方法可有效消除样品中的抑菌成分,各品种所建立的方法均能符合验证要求。结论:经验证的微生物限度检查方法既客观地反映样品中微生物的污染状况,且方法简便、准确,可用于制剂质量控制。
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| 关 键 词： | 外用医院制剂 微生物限度检查 方法验证 |
The Validation Methods of Microbial Limit Tests for Ten Kinds of External Hospital Preparations |
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| Li Xiangping,Li Wen,Xu Wenmin and Mo Jinna. The Validation Methods of Microbial Limit Tests for Ten Kinds of External Hospital Preparations[J]. , 2012, 13(4): 290-292 |
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| Authors: | Li Xiangping Li Wen Xu Wenmin Mo Jinna |
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| Affiliation: | 1. The second Affiliated Hospital of School of Medicine of Shantou University, Shantou 515041 ; 2. Shantou Institute for Drug Control, Shantou 515010) |
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| Abstract: | Objective： To establish ＂microbial limit tests＂ methods for ten kinds of external hospital preparations. Methods： Using normal plate count method,medium dilution method,membrane filtration method to check sample＇s microbial limit. All methods are validated according to the procedure in China Pharmacopeia （2010 edition）. Results： Proper methods which were establish above can eliminate antibacterial matters and pass the method＇s validation. Conclusions： Microbial limit test methods which are validation above are convenient and accuracy. They can be used for quality control of external hospital preparations. |
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| Keywords: | external hospital preparations microbial limit tests validation |
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