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.

traditional Chinese medicine solid preparations  /  continuous manufacturing  /  database  /  mathematical model  /  process analytical technology