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中药群体药代动力学专家共识(征求意见稿)
引用本文:谢雁鸣,王建农,贺福元,姜俊杰,熊昕.中药群体药代动力学专家共识(征求意见稿)[J].中国中药杂志,2013,38(18):2937-2942.
作者姓名:谢雁鸣  王建农  贺福元  姜俊杰  熊昕
作者单位:中国中医科学院 中医临床基础医学研究所, 北京 100700;中国中医科学院 西苑医院, 北京 100091;湖南中医药大学, 湖南 长沙 410208;中国中医科学院 中医临床基础医学研究所, 北京 100700;北京大学 第三医院, 北京 100191
基金项目:国家"重大新药创制"科技重大专项(2009ZX09502-030);中国中医科学院客座研究员联合创新项目(ZZ070834)
摘    要:中药群体药代动力学(population pharmacokinetics,PPK)研究以治疗窗窄的有毒中药、或目标人群极不均一的中药、或不良反应较多的中药为研究对象,选择中药中有确切治疗作用的已知成分、有毒成分、有毒代谢酶为研究指标,采用完整的PPK采样设计方法制定采样时间点和样本量。利用气相色谱法、高效液相色谱法、色谱-质谱联用法等方法检测目标成份。最终采用总量统计矩分析方法拟合各成份PPK参数,获得能体现中药整体趋势的PPK模型,为临床合理调整给药剂量提供依据。

关 键 词:中药  群体药代动力学  专家共识
收稿时间:8/1/2013 12:00:00 AM

Expert consensus on population pharmacokinetics of Chinese medicine(draft version for comments)
XIE Yan-ming,WANG Jian-nong,HE Fu-yuan,JIANG Jun-jie and XIONG Xin.Expert consensus on population pharmacokinetics of Chinese medicine(draft version for comments)[J].China Journal of Chinese Materia Medica,2013,38(18):2937-2942.
Authors:XIE Yan-ming  WANG Jian-nong  HE Fu-yuan  JIANG Jun-jie and XIONG Xin
Institution:Institute of Basic Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China;Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China;Hunan University of Chinese Medicine, Changsha 410208, China;Institute of Basic Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China;Third Hospital, Peking University, Beijing 100191, China
Abstract:In population pharmacokinetic (PPK) research of Chinese medicines with narrow therapeutic windows of toxicity, or when the target population is not homogeneous, or when there are frequent adverse reactions to parenterally administered Chinese medicine, select those that have a definite therapeutic effect, and in which the compositions of the toxic substances compositions are known, for study, and use complete PPK sampling design to take samples at specific time points. Use gas chromatography, HPLC, and LC-MS methods for the detection of target components. Finally, use total quantity statistical moment analysis, to account for each component of the PPK parameters. Thus, PPK model can reflect the overall trend of Chinese medicine, to provide the basis for reasonable clinical dosage adjustments.
Keywords:Chinese medicine  population pharmacokinetics  expert consensus
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