| 从美国首个被批准植物药探讨中药药代动力学研究与评价策略 |
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| 引用本文： | 黄芳华.从美国首个被批准植物药探讨中药药代动力学研究与评价策略[J].中国中药杂志,2010,35(7):932-935. |
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| 作者姓名： | 黄芳华 |
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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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| 基金项目： | 国家科技支撑计划项目(2006BAI21B10) |
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| 摘 要： | 药代动力学研究是药物开发中的重要内容之一。2006年美国食品药品管理局(FDA)批准了首个植物药Vere-gen。本研究结合FDA对植物药药代动力学的要求、Veregen被批准所依据的药代动力学研究资料,并结合目前国内对中药、天然药物药代动力学的技术要求及研究现状,对中药、天然药物的药代动力学研究及评价策略进行讨论。
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| 关 键 词： | 药代动力学 中药 植物药 |
| 收稿时间： | 2009/10/7 0:00:00 |
Discussion about traditional Chinese medicine pharmacokinetics study based on first botanical drug approved by FDA |
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| HUANG Fanghua.Discussion about traditional Chinese medicine pharmacokinetics study based on first botanical drug approved by FDA[J].China Journal of Chinese Materia Medica,2010,35(7):932-935. |
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| Authors: | HUANG Fanghua |
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| Institution: | Center for Drug Evaluation, State Food and Drug Administration, Beijing 100038,China |
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| Abstract: | Pharmacokinetics study is one of main components of pharmaceuticals development. Food and Drug Administration (FDA) approved Veregen as the first botanical drug in 2006. This article introduced FDA's requirement on pharmacokinetics study of botanical drug and pharmacokinetics studies of Veregen, summarized current requirement and status quo of pharmacokinetics study on traditional Chinese medicine(TCM) and natural medicine in China, and discussed about pharmacokinetics study strategy for TCM and natural medicine. |
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| Keywords: | pharmacokinetics study traditional Chinese medicine botanical drug |
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