| 原料药杂质研究与控制浅析 |
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| 引用本文： | 郝杰,张哲峰,毕小平.原料药杂质研究与控制浅析[J].中国现代应用药学,2015,32(6):757-763. |
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| 作者姓名： | 郝杰 张哲峰 毕小平 |
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| 作者单位： | 山西医科大学药学院，太原 030001,国家食品药品监督管理总局药品审评中心，北京 100038,山西医科大学药学院，太原 030001 |
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| 摘 要： | 原料药质量优劣是药品质量控制的关键和源头。原料药杂质研究及控制又是原料药质量保证的关键要素之一，也是保证药品安全性和可控性的重要评价指标。本文从原料药的杂质分类、杂质分析方法、国内外原料药杂质研究现状等方面阐述了原料药中杂质检查与控制的重要性，对于药物研究、药物生产、储存、运输等环节确保药品安全有效具有一定的实用价值。
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| 关 键 词： | 原料药 杂质 控制 |
| 收稿时间： | 2014/11/11 0:00:00 |
| 修稿时间： | 5/4/2015 12:00:00 AM |
Analysis of Method for Testing and Controlling the Impurity of Crude Drug |
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| HAO Jie,ZHANG Zhefeng and BI Xiaoping.Analysis of Method for Testing and Controlling the Impurity of Crude Drug[J].The Chinese Journal of Modern Applied Pharmacy,2015,32(6):757-763. |
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| Authors: | HAO Jie ZHANG Zhefeng and BI Xiaoping |
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| Institution: | School of Pharmacy, Shanxi Medical University, Taiyuan 030001, China,Center for Drug Evaluation, State Food and Drug Administration, Beijing 100038, China and School of Pharmacy, Shanxi Medical University, Taiyuan 030001, China |
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| Abstract: | The high quality of crude drug is the key to the source and controlling of drug quality. Research and control impurities of crude drug is not only the key elements of quality guarantee, but also is the important evaluation indexes of ensuring drug safety and controllability. In this paper, related progesses in rencent years were summarized, including the classification and analysis method of impurities and so on. This paper also expounds the importance of crude duge impurities in the inspection and control, it is practical value for drug research, production, storage, transportation and other links to ensure that the drug is safe and effective. |
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| Keywords: | crude drug impurity control |
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