中药缓控释制剂发展历史悠久，但现代中药缓控释制剂因中药化学成分复杂、物质基础不明确和质量评价体系不健全等限制了其发展。中药缓控释制剂设计与评价成为中药制剂领域亟需攻克的科学问题。中药制剂不能像化学药物仅依靠药物动力学与释药动力学方法建立剂型设计与评价研究方法。中药缓控释制剂可结合以超分子“印迹模板”整合成分群为释药“物质单元”来进行重构，关联谱动学与谱效动力学进行生物药剂学评价。因此，提出以谱动学与谱效动力学关联构建具超分子释药“物质单元”特征的中药缓控释制剂设计与评价生物药剂学研究方法，符合中药多成分整体受控、同步释放制剂制备指导原则。超分子释药的“物质单元”结合中药谱动学与谱效动力学建立中药缓控释制剂处方设计和多成分缓控释制剂评价标准体系，旨在为建立符合中药制剂特征的生物药剂学研究方法提供参考。

The development of sustained and controlled release preparations of traditional Chinese medicine (TCM) has a long history, but the development of modern sustained and controlled release preparations of TCM is limited by the complex chemical composition of TCM, the unclear material basis and the unsound quality evaluation system. The design and evaluation of sustained and controlled release preparations of TCM have become a scientific problem that needs to be overcome in the field of TCM preparation. TCM preparation cannot rely on pharmacokinetic and release kinetic methods alone to establish dosage form design and evaluation research methods as chemical drug. The sustained and controlled release preparations of TCM can be reconstructed by integrating groups of ingredients into supramolecular “imprinted templates” as the “substance unit” for drug release, and biopharmaceutical evaluation can be carried out by correlating spectrokinetics and spectropharmacodynamics. Therefore, this paper proposes a biopharmaceutical research method for the design and evaluation of sustained and controlled release preparations of TCM with the characteristics of supramolecular drug release “substance unit” by correlating spectrokinetics and spectropharmacodynamics, which is in line with the guiding principle of the preparation of Chinese medicine multi-component integrated controlled and synchronous release formulations. In order to provide reference for the establishment of biopharmaceutical research methods in accordance with the characteristics of TCM preparation, the formulation design and evaluation standard system of multi-component sustained and controlled release preparations are established by combining the “substance unit” of supramolecular drug release with the spectrokinetics and spectropharmacodynamics of TCM.

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国家自然科学基金资助项目（82274215）；国家自然科学基金资助项目（81874507）；湖南省自然科学基金面上项目（2021JJ30509）；湖南中医药大学2021年度校级科研基金（2021XJJJ002）