| 8种医院制剂微生物限度检查方法验证 |
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| 引用本文： | 孙莺,郭朝晖,宋京都.8种医院制剂微生物限度检查方法验证[J].中国药事,2014(8):839-842. |
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| 作者姓名： | 孙莺 郭朝晖 宋京都 |
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| 作者单位： | 甘肃省食品药品检验所,甘肃省中药品质与安全评价工程技术研究中心,兰州730000 |
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| 摘 要： | 目的 建立8种医院制剂的微生物限度检查方法.方法 按《中国药典》2010年版附录微生物限度检查法中细菌、霉菌及酵母菌计数方法和控制菌检查法进行验证.结果 供试品5种试验菌回收率均高于70％,控制菌均能正常检出.结论 医院制剂必须进行微生物限度检查方法验证,才能保证检验结果的正确性.
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| 关 键 词： | 医院制剂 微生物限度 方法验证 回收率 |
Validation of Microbial Limit Test Method of Eight Hospital Preparations |
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| Sun Ying,Guo Zhaohui and Song Jingdu.Validation of Microbial Limit Test Method of Eight Hospital Preparations[J].Chinese Pharmaceutical Affairs,2014(8):839-842. |
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| Authors: | Sun Ying Guo Zhaohui and Song Jingdu |
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| Institution: | (Gansu Institute for Food and Drug Control, Gansu Engineering Technological Research Center of Chinese Medicines Quality Evaluation and Safety Assessment, Lanzhou 730000) |
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| Abstract: | Objective To establish a method for the microbial limit test of 8 hospital preparations. Methods A validation on the microbial limit test method was conducted in accordance with the counting method of bacteria, mycetes and yeasts and the control bacteria test method stated in the Appendix of China Pharmacopoeia （2010 edition）. Results The recoveries of five test organisms were higher than 70 %, the control microorganisms were properly detected. Conclusion Hospital preparations should undergo validation with the microbial limit test method to ensure the correctness of test results. |
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| Keywords: | hospital preparations microbial limit validation of method recovery rate |
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