| 中成药质量标准化建设的现状及展望 |
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| 引用本文： | 高学敏,张建军,张德芹,王景霞,欧丽娜,陈绍红.中成药质量标准化建设的现状及展望[J].中国中药杂志,2007,32(9):868-872. |
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| 作者姓名： | 高学敏 张建军 张德芹 王景霞 欧丽娜 陈绍红 |
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| 作者单位： | 1. 北京中医药大学,基础医学院,方药学系,北京,100029
2. 天津中医药大学,中医药研究中心,天津,300193 |
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| 摘 要： | 通过回顾我国传统中成药品种的整顿工作,中成药品种的保护工作,新药审评方法的建立和不断完善以及中国药典的历史沿革和发展,对我国中成药质量标准化建设的现状进行了分析；剖析了在新的历史时期我国中成药质量标准化建设所面临的问题和挑战；并提出了使中成药走向世界、与国际接轨的策略和中医药工作者今后的努力方向。
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| 关 键 词： | 质量标准 中药保护 新药审评 |
| 文章编号： | 1001-5302（2007）09-0868-05 |
| 收稿时间： | 2006-10-20 |
| 修稿时间： | 2006-10-20 |
Present situation and prospect of quality standardization of Chinese patent medicines |
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| GAO Xue-min; ZHANG Jian-jun; ZHANG De-qin; WANG Jing-xia; OU Li-na; CHEN Shao-hong.Present situation and prospect of quality standardization of Chinese patent medicines[J].China Journal of Chinese Materia Medica,2007,32(9):868-872. |
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| Authors: | GAO Xue-min; ZHANG Jian-jun; ZHANG De-qin; WANG Jing-xia; OU Li-na; CHEN Shao-hong |
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| Institution: | 1. Department of Chinese Herbal Formulae and Materia Medica, School of Preclinical Medicine, Beijing University of Chinese Medicine, Beijing 100029, China ; 2. Research Center of Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Beijing 300193, China |
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| Abstract: | This article reviews rectification and protection of Chinese patent medicines,establishment and improvement of the new drug approval,and historical evolution of the pharmacopoeia of the People's Republic of China.The article analyzes the present situation and the challenges of quality standardization of Chinese patent medicines in the new era.The article also points out strategies and guidelines to be taken to promote the globalization of Chinese patent medicines and compliance with the international standards. |
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| Keywords: | quality standardization Chinese patent medicines new drug approval |
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