| 三黄消渴片微生物限度检查方法验证探讨 |
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| 引用本文： | 薛洁,闫柏琴,韩荣,曹燕玲. 三黄消渴片微生物限度检查方法验证探讨[J]. 中华中医药杂志, 2008, 23(8) |
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| 作者姓名： | 薛洁 闫柏琴 韩荣 曹燕玲 |
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| 作者单位： | 1. 新疆医科大学附属中医医院,乌鲁木齐,830000
2. 新疆维吾尔自治区药品检验所,乌鲁木齐,830002 |
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| 摘 要： | 目的:建立三黄消渴片微生物限度检查方法。方法:按中国药典2005版规定采用5种阳性对照菌回收率试验测定其是否含抑菌成分。结果:按供试品制备方法,各试验菌样品中的回收率均达到70%以上。结论:三黄消渴片所采用的检验方法可以消除药品的抑菌作用,可以有效地检出污染的微生物,使测定结果准确,药品质量安全有效,达到验证实验的目的。
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| 关 键 词： | 微生物限度方法验证 回收率 药品质量 |
Validation method of microbial limits of Sanhuangxiaoke pill |
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| XUE Jie,YAN Bai-qin,HAN RongCAO Yan-ling. Validation method of microbial limits of Sanhuangxiaoke pill[J]. China Journal of Traditional Chinese Medicine and Pharmacy, 2008, 23(8) |
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| Authors: | XUE Jie YAN Bai-qin HAN RongCAO Yan-ling |
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| Affiliation: | XUE Jie1,YAN Bai-qin1,HAN Rong1CAO Yan-ling |
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| Abstract: | Objective:To establish the validation method of microbial limits of Sanhuangxiaoke pill.Methods:According to the People's Republic of China Pharmacopoeia,recovery rate with5positive control trains were used to determine the antimicrobial effect.Results:According to the results,the recovery rates were higher than70%by preparation of sample.Conclusion:Sanhuangxiaoke pill preparations can elimination the bacteriostatic action with accurate result and reach the objective. |
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| Keywords: | Validation method of microbial limit Recovery rate Quality of drugs |
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