| 阿莫西林口服制剂微生物限度检查方法学验证研究 |
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| 引用本文： | 王艳,李晓平,刘珠,支丽娟,王淑娟.阿莫西林口服制剂微生物限度检查方法学验证研究[J].中国药房,2011(29):2758-2760. |
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| 作者姓名： | 王艳 李晓平 刘珠 支丽娟 王淑娟 |
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| 作者单位： | 河北省药品检验所;河北省儿童医院;长春工业大学; |
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| 摘 要： | 目的:建立阿莫西林口服制剂微生物限度的检查方法。方法:供试液采用一般处理或加入不同量青霉素酶进行处理,考察阿莫西林颗粒、胶囊、分散片3种剂型中金黄色葡萄球菌、大肠埃希菌、枯草芽孢杆菌、白色念珠菌、黑曲霉5种菌的回收率,确定阿莫西林的敏感菌,同时对建立的方法进行验证。结果:3种阿莫西林制剂供试液在一般处理下白色念珠菌、黑曲霉的回收率均大于70%,但各细菌回收率为0;各制剂供试液在加入酶后各菌回收率大于70%,但分散片供试液对大肠埃希菌的回收率小于70%,在加大酶加入量后达到70%;大肠埃希菌为敏感菌,验证试验表明方法可行。结论:在阿莫西林口服制剂的微生物限度检查中,霉菌及酵母菌计数可采用平皿法,细菌计数可采用加入酶后的平皿法。
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| 关 键 词： | 阿莫西林 颗粒 胶囊 分散片 微生物限度 青霉素酶 方法验证 |
Methodology Validation of Microbiological Limit Test for Amoxicillin Oral Preparation |
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| WANG Yan,LI Xiao-ping,LIU Zhu ZHI Li-juan WANG Shu-juan.Methodology Validation of Microbiological Limit Test for Amoxicillin Oral Preparation[J].China Pharmacy,2011(29):2758-2760. |
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| Authors: | WANG Yan LI Xiao-ping LIU Zhu ZHI Li-juan WANG Shu-juan |
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| Institution: | WANG Yan,LI Xiao-ping,LIU Zhu(Hebei Provincial Institute for Drug Control,Shijiazhuang 050011,China) ZHI Li-juan(Children's Hospital of Hebei Province,Shijiazhuang 050031,China) WANG Shu-juan(Changchun University of Technonolgy,Changchun 130012,China) |
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| Abstract: | OBJECTIVE:To establish a method for microbiological limit test of amoxicillin oral preparation. METHODS:Test samples were treated with routine method and method added different amounts of penicillinase. The recoveries of Staphylococcus aureus,Escherichia coli,Bacillus subtilis,Candida albicans and Aspergillus niger in Amoxicillin granule,capsule and dispersible tablet were determined to confirm sensitive bacteria of amoxicillin. Established method was validated. RESULTS:The recoveries of Candida albicans an... |
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| Keywords: | Amoxicillin Granules Capsule Dispersible tablet Microbiological limit test Penicillinase Methodology validation |
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