中药工业智能制造转型模式及监管问题探讨  

The Mode of the Transformation of Intelligent Manufacturing in Chinese Medicine Industry and the Discussions on Regulatory Concerns

作　　者：张磊[1,2] 孟昭平 岳洪水 于淼 李萌 鞠爱春 ZHANG Lei;MENG Zhaoping;YUE Hongshui;YU Miao;LI Meng;JU Aichun(Tianjin Tasly Pride Pharmaceutical Co.,Ltd.,Tianjin 300410,China;Tianjin Key Laboratory of Safety Evaluation Enterprise of Traditional Chinese Medicine Injections,Tianjin 300410,China;Center for Information,National Medical Products Administration,Beijing 100044,China)

机构地区：[1]天津天士力之骄药业有限公司,天津300410 [2]天津市中药注射剂安全性评价企业重点实验室,天津300410 [3]国家药品监督管理局信息中心,北京100044

出　　处：《中国医药导刊》2024年第2期129-138,共10页Chinese Journal of Medicinal Guide

摘　　要：中药制药工业质量控制水平的提升需要以科技创新为引领,以先进制药工程技术为支撑。智能制造融合了先进制造技术与信息技术,已经成为提高制造业质量与效益的先进生产方式。本研究聚焦中药工业实施智能制造重大战略工程,根据中药产品质量及其制造流程的特点,结合中药制药工业面临的管控问题以及智能制造技术特征,提出中药产业发展智能制造的转型方向,核心包括由基于经验的控制向以数据为驱动力的控制转型、产品检验向过程管控转型、分散向集成转型,以及药品制造向药品全生命周期服务转型等领域的突破。总结近年来中药标杆性企业在智能制造技术研究方面取得的成果以及产业转化进展,讨论中药产业在智能制造转型过程中面临的监管问题,以期为中药工业实施智能制造项目的系统架构规划与技术路线设计提供参考。The improvement of quality control level of Chinese medicine(CM)industry demands the guide of innovation in science and technologies,and the support of advanced pharmaceutical manufacturing engineering technologies.Intelligent manufacturing which integrates advanced manufacturing technologies and information technologies,has become the advanced manufacturing made to increase the quality and efficiency of manufacturing industry.Focusing on the major strategic project of intelligent manufacturing implemented in CM industry,this study proposed the transformation directions of developing intelligent manufacturing in CM industry,which were based on the characteristics of CM product quality and manufacturing process,as well as the problems of quality management and control faced by CM industry and the advantages of intelligent manufacturing technologies.Four directions were proposed,including the transformation from experience-based control to data-driven control,the transformation from product-test mode to process control and management mode,the transformation from separation to integration,and the transformation from drug product manufacturing to the full life cycle ser-vice of drug product.The achievements and industrial application of intelligent manufacturing by representative CM enterprise were intro-duced,and the regulatory concerns generated from the intelligent manufacturing transformation of CM industrial were discussed.This paper provides reference for CM industry to plan systematic architecture and design technical chart when developing intelligent manufac-turing projects.

关 键 词：中药工业 智能制造 监管科学 先进制药技术 

分 类 号：R95[医药卫生—药学]