PK-PD结合模型研究现状及其应用于中医药领域面临挑战.pdfVIP

中草药 Chinese Traditional and Herbal Drugs 第44 卷 第2 期 2013 年1 月 ·121 · ·专 论 · PK-PD 结合模型的研究现状及其应用于中医药领域面临的挑战 张忠亮，李 强，杜思邈，李秋芬，吕春明，张 宁* 上海中医药大学 科技实验中心，上海 201203 摘 要：药动学-药效动力学（pharmacokinetic-pharmacodynamic ，PK-PD ）结合模型是研究药物剂量与药物效应之间定量关 系的有效工具，能较客观地阐明“时间-血药浓度-效应”之间三维关系，对于制剂的研发、作用机制研究、临床用药优化及 合理应用有重要的参考价值。因此，建立能体现中医药特色的PK-PD 结合模型十分必要。针对PK-PD 模型在新药研发中的 应用趋势进行展望的同时对其在中医药研究领域的应用现状进行较系统的阐述，并就中药效应物质基础的确定、效应指标的 选择等关键问题进行探讨并提出建议，以期为今后的相关研究提供参考。 关键词：药动学；药效动力学；PK-PD 模型；中药；新药研发 中图分类号：R285 文献标志码：A 文章编号：0253 - 2670(2013)02 - 0121 - 07 DOI: 10.7501/j.issn.0253-2670.2013.02.001 Research status of pharmacokinetic-pharmacodynamic model and its challenges facing to application in traditional Chinese medicine field ZHANG Zhong-liang, LI Qiang, DU Si-miao, LI Qiu-fen, LV Chun-ming, ZHANG Ning Technology Experiment Center, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China Abstract ：Pharmacokinetics-pharmacodynamics (PK-PD) combined model is an effective tool for studying the quantitative relationship between the drug dose and drug effect, it could clarify the three-dimensional relationship of “time-concentration-effect” more scientifically and provide the reference for the preparation development, mechanism research, clinical treatment optimization, and rational use. It is very necessary to establish the PK-PD combined model that embodies the characteristics of traditional Chinese medicine (TCM). In this paper, the application trends of PK-PD combined model in the development of new drugs are discussed. The application status in the field of TCM research has been systematicly explained and the key problems, such as the investigation of material basis of TCM effects and the selection of effect indicators are studied to make recommendations so as to p