中药制药过程涉及的溶液环境复杂，成分多以分子态、离子态、缔合态、复合态等多状态共存体系形式存在，造成制药环节中多样性的物质传递规律，出现制剂均一性和稳定性难以控制的生产现状。通过对现有的成分状态分析技术手段进行综述，并基于成分存在状态与溶液环境的相关性，构建限域传质数学模型，定量拟合复杂溶液体系中成分状态和缔合系数，进而结合溶液环境调控与超声剥离技术，为中药复杂溶液体系中超分子化合物的解析提供研究思路。根据“生产参数-成分状态-物质转移”的内在关系，构建中药制剂生产调控的新理念，从而提升中药制剂生产的有序性和可控性。

The solution environment involved in the pharmaceutical process of traditional Chinese medicine (TCM) is complex, with components coexisting in multiple states—including molecular, ionic, aggregated, and composite forms. This leads to diverse mass transfer patterns during manufacturing and poses challenges in controlling the uniformity and stability of the final preparations. This review summarizes existing analytical techniques for characterizing component states. By establishing the correlation between component states and the solution environment, a confined mass transfer mathematical model is developed to quantitatively describe component states and association coefficients in complex TCM solutions. Combined with strategies for modulating the solution environment and ultrasonic-assisted delamination techniques, this approach provides a methodological framework for resolving supramolecular assemblies in TCM systems. Furthermore, based on the intrinsic relationship among production parameters, component states, and mass transfer behavior, a new concept for regulating TCM preparation processes is proposed, aiming to enhance the orderliness and controllability of TCM production.

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国家自然科学基金资助项目（82274106）；中药制药过程控制与智能制造技术全国重点实验室创新项目（NZYSKL240207）；南京中医药大学中药学一流学科科学研究培育项目（ZYXPY2024-006）