| 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. |
| HAO Jie,ZHANG Zhefeng,BI Xiaoping.Analysis of Method for Testing and Controlling the Impurity of Crude Drug[J].Chin J Mod Appl Pharm(中国现代应用药学),2015,32(6):757-763. |
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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。 |
| 关键词: 原料药 杂质 控制 |
| DOI： |
| 分类号:R917 |
| 基金项目: |
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| Analysis of Method for Testing and Controlling the Impurity of Crude Drug |
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HAO Jie1, ZHANG Zhefeng2, BI Xiaoping1
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1.School of Pharmacy, Shanxi Medical University, Taiyuan 030001, China;2.Center for Drug Evaluation, State Food and Drug Administration, Beijing 100038, 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. |
| Key words: crude drug impurity control |
