中药固体制剂是中医药产业的主要剂型，其制造模式正由传统批生产向连续制造加速转型。中药成分复杂、物料属性波动大、工艺过程呈强非线性，使在线检测与动态质量评价面临显著挑战。围绕中药固体制剂连续制造的技术特征，系统梳理了当前在线检测与动态质量评价面临的发展瓶颈；在此基础上，重点综述了多维工艺-质量数据库构建、机理模型与数据驱动模型融合、过程分析技术在关键工序中的应用，及数字孪生与闭环调控平台的技术路径。未来可进一步探索以“数据-模型-控制”深度融合为核心，推动在线检测由被动监测向主动预测与自适应调控转变，逐步建立符合中药特点的动态质量评价体系，为中药固体制剂制造的标准化、智能化与高质量发展提供理论依据与技术参考。

Traditional Chinese medicine (TCM) solid preparations represent the primary dosage form in the TCM industry, and their manufacturing model rapidly transitioning from traditional batch production to continuous manufacturing. The complex composition of TCM ingredients, significant variability in material properties, and highly nonlinear process characteristics pose substantial challenges for online monitoring and dynamic quality evaluation. This paper systematically examines the developmental bottlenecks currently faced by online monitoring and dynamic quality evaluation in the context of continuous manufacturing of TCM solid preparations, focusing on their technical features. It provides a comprehensive review of approaches such as the construction of multidimensional process-quality databases, integration of mechanistic models with data-driven models, application of process analysis techniques at critical stages, and the implementation of digital twin and closed-loop control platforms. Future research should further explore the deep integration of “data-model-control” frameworks to transform passive monitoring into proactive prediction and adaptive regulation, thereby establishing a dynamic quality evaluation system tailored to the unique characteristics of TCM. This will provide theoretical foundations and technical references for standardizing, intelligentizing, and enhancing the quality of TCM solid preparation manufacturing.

R283

江西省自然科学基金资助项目（20224BAB216103）；国家重点研发计划资助项目（2018YFC1707203）；江西省博士后研究人员科研项目择优资助项目（2021KY45）；景德镇市重大科技研发专项“揭榜挂帅”项目（景财科指[2022]41号）；技术开发委托合同编号（53523807）；钟凌云全国老药工传承工作室（国中医药人教函[2024]255号）；郭晓秋江西省老药工传承工作室（赣中医药科教函[2025]10号）；国家中医药管理局“中药改良创新和智能制造技术示范中心建设”项目（0686-2511CA083418Z）；江西中医药大学大学生创新创业训练计划项目（202610412257）