| 化学药品复方制剂中有关物质的定性归属方法 |
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| 引用本文： | 张震,张玉琥. 化学药品复方制剂中有关物质的定性归属方法[J]. 中国新药杂志, 2008, 17(21) |
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| 作者姓名： | 张震 张玉琥 |
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| 作者单位： | 国家食品药品监督管理局药品审评中心,北京,100038 |
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| 摘 要： | 针对目前国内化学药品复方制剂研究中存在有关物质研究方法的不规范和限度确定的不合理,本文建议在复方制剂的有关物质研究中,对各主成分的有关物质进行分别研究和控制,并对复方制剂中有关物质定性归属的几种研究方法进行了讨论.
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| 关 键 词： | 复方制剂 有关物质 定性归属 |
Identification methods for the related substances in compound products of chemical drugs |
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| ZHANG Zhen,ZHANG Yu-hu. Identification methods for the related substances in compound products of chemical drugs[J]. Chinese Journal of New Drugs, 2008, 17(21) |
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| Authors: | ZHANG Zhen ZHANG Yu-hu |
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| Affiliation: | ZHANG Zhen,ZHANG Yu-hu(Center for Drug Evaluation,State Food , Drug Administration,Beijing 100038,China) |
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| Abstract: | Nowadays there have been many problems in the research methods of the related substances of the compound drug products in the domestic researchers,including wrong ways for research and illogical determination of the threshold.In this article,we suggested that the related substances that belong to different main components should be researched and controlled,respectively.Several ways for the identification of related substances in the compound drug products has been discussed as well. |
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| Keywords: | compound drug products related substance identification study |
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