依据“方证相应”科学原理,借鉴药物动力学、药效动力学结合模型(PK/PD结合模型),针对“中药生物药剂学”研究的技术关键问题①中药复方的组方配伍均可明显影响中药化学成分在体内的药动学,并与疗效和毒副作用密切相关,如何通过生物药剂学的模式描述此类作用?②正常和病理状态下的药动学过程有所不同,生物药剂学所用动物模型如何体现“证”的特征?③方作用于证,使证递减与转化,在机体生理、病理指标与药物分布等时空变化呈现动态对应状态下,如何确认方的药效物质种类及其数量?提出以PK/PD为基本研究手段的中药生物药剂学研究模式:①以“效”为核心,同时辅以成分药动学,更好的体现中医药的整体性;②综合多种主要药效成分的药动学与药效学,构筑“整合药动学/药效学”评价体系;③采用数据挖掘技术,建立“时间-浓度-效应”三相同步表征的PK/PD数学函数,探讨“方证相应”有关“有是证即有是方,有证而为,无证而不为”机制的生物药剂学表达模式。 Based on the scientific theory of “Corresponding to the square certificate” and referring to the pharmacokinetic and pharmacodynamics combined model (PK / PD binding model), the key technical problems of the research on “Chinese traditional medicine biopharmaceutical” Compatibility can significantly affect the chemical composition of Chinese medicine in vivo pharmacokinetics, and with the efficacy and side effects are closely related, how to describe the role of biopharmaceutical mode? ② normal and pathological pharmacokinetic process is different How to confirm the characteristics of the animal model used in biopharmaceuticals to reflect the characteristics of the “card”? ③ side effect on the card, the card decrement and conversion, in the body physiology, pathological indicators and the distribution of drugs and other temporal and spatial changes showed dynamic state, how to confirm the side The type and amount of pharmacodynamic substances proposed by the PK / PD as the basic research methods of traditional Chinese medicine biopharmaceutical research: ① “” effect as the core, supplemented by component pharmacokinetics, and better reflect the traditional Chinese medicine The integration of a variety of main pharmacodynamic pharmacodynamics and pharmacodynamics, build “integrated pharmacokinetics / pharmacodynamics ” evaluation system; 3 using data mining technology to establish “time - concentration - Effect ”Three-phase synchronous characterization PK / PD number Function to explore “party card corresponding ” about “There is evidence that is square, there is evidence for, not for undocumented ” Biopharmaceutics expression pattern mechanism.