基于数据驱动的中药制药过程质量标志物（Q-Marker）监测方法研究及实践

建立符合中药特点的制药过程质量监测体系是提升中药质量水平的关键措施。中药质量标志物（quality marker,Q-Marker）创新概念的提出，为中药质量表征开辟了新模式。中药产业智能化转型中产生的工业大数据将成为企业的核心资产，对这些数据进行充分挖掘将为质量监测技术开发提供有力支撑。依托前期研究成果，提出基于数据驱动的中药制药过程Q-Marker监测方法，介绍了该方法的技术路线，包括中药Q-Marker监测指标识别，制药工业质量数据挖掘及过程分析技术体系建立3个关键步骤，并阐述了实施各步骤所涉及的关键技术。最后，以注射用益气复脉（冻干）生产过程超滤工序为例，介绍了该方法在中药工业质量监测中的具体应用，为智能化时代下，中药工业构建具有自身特色的质量控制技术提供参考。

Method for monitoring quality marker in manufacturing process of traditional Chinese medicine based on data-driving and its application

The establishment of a quality monitoring system for the pharmaceutical process that meets the characteristics of traditional Chinese medicine (TCM) is a key measure to improve the quality of TCM. The initiation of the innovative concept of TCM quality marker (Q-Marker) made a new mode for quality characterization of TCM. The industrial big data generated in the intelligent transformation of the TCM industry will become the core assets of enterprises, and the full mining of these data will provide powerful support for the development of quality monitoring technology. Relying on the results of previous research, a method for monitoring Q-Markers in the manufacturing process of TCM based on data-driving was proposed in this paper. The technical route of the method with three key steps was presented, which included the identification of Q-Markers as process monitoring indications, quality data mining in pharmaceutical industries, and building process analytical technology system. The key technologies for each step were introduced. Finally, the method was applied to the process quality monitoring in TCM manufacturing, in the case of the ultrafiltration process in the production of Yiqi Fumai Lyophilized Injection. This paper provided reference for TCM industry to establish quality control technologies with its own characteristics.