通过了解美国食品药品监督管理局（Food and Drug Administration，FDA）的《连续制造的质量考虑指导原则》，结合片剂连续制造、中药智能制造的研究进展以及智能制造相关的方法进展，探索中药智能制造的分级研究思路。建议中药智能制造从3个层次进行研究：（1）中药智能制造的总体研究，从中药智能制造的全过程质量控制角度考虑其质量控制的注意事项。如生产过程的关注点、控制策略、工艺验证、扩大生产规模（如适用）、将已有生产工艺桥接到智能制造（如适用）。（2）中药智能制造的共性技术方法研究，如过程分析技术研究、数字化研究、建模研究、基于模型的实时反馈研究、自适应控制研究。（3）中药固体口服制剂智能制造的研究。

By understanding Food and Drug Administration (FDA)'s Quality Considerations for Continuous Manufacturing Guidance for Industry, combined with research progress on continuous manufacturing of tablets and smart manufacturing of traditional Chinese medicine (TCM), as well as research progress on related methods of smart manufacturing, the classification research ideas of smart manufacturing of TCM were considered. It is suggested that smart manufacturing of TCM can be studied from three levels:(1) The overall study of smart manufacturing of TCM:From the perspective of the whole process quality control of smart manufacturing of TCM, the points for attention in quality control were considered such as manufacturing process concerns, control strategies, process validation, scaling up production (if applicable), bridging existing manufacturing processes to smart manufacturing (if applicable); (2) Study on generic technology and method of smart manufacturing of TCM such as process analytical technology research, digitization research, modeling research, model-based real-time feedback research, adaptive control research; (3) Smart manufacturing of solid oral preparations.

R288

国家自然科学基金资助项目（81503347）；北京中医药大学中央高校基本科研业务费项目（2021-JYB-XJSJJ037）