世界中医药

作者	单位
于佳琦1，徐冰1，2，3，姚璐4，戴幸星1，2，3，史新元1，2，3，乔延江1，2，3	1 北京中医药大学中药信息学系，北京，102400； 2 北京市科委中药生产过程控制与质量评价北京市重点实验室，北京，100029； 3 教育部中药制药与新药开发关键技术工程研究中心，北京，100029； 4 北京同仁堂股份有限公司科学研究所，北京，100079

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中文摘要:

以质量源于设计（Quality by Design，QbD）为基础的制药质量体系，逐渐将智能装备、工业信息化软件、大数据和云计算等智能化工具纳入生产质量管控和知识管理系统。智能制造引领着中药产业的转型升级，面对不断涌现的智能制造新技术和新模式，本文引入智能制造成熟度等级模型，评价分析了当前中药智能制造主要处于规范级（即数字化和标准化）和集成级阶段，未来朝向优化级和引领级发展。提出由连续制造、信息集成、智能模拟和智慧应用组成的中药智能制造关键技术体系。人工智能和先进制造技术的深度融合将催生新一代中药智能制造模式，实现工艺知识和模型的应用，以及生产过程感知和控制决策的闭环。

English Summary:

The quality by design (QbD) based pharmaceutical quality system has gradually incorporated intelligent tools, such as smart equipment, industrial information software, big data and cloud computing, into its production control and knowledge management systems. Intelligent manufacturing has led the change of Chinese medicine industry. In the face of emerging new technologies and intelligent manufacturing tools, this paper introduced the intelligent manufacturing maturity model, evaluated and analyzed the current status of Chinese medicine manufacturing. It was concluded that the Chinese medicine manufacturing was mainly at the stage of digitization, standardization and integration, and would move towards the optimization level and leading level in the future. Four key technologies——continuous manufacturing, information integration, intelligent simulation and intelligent application were proposed for intelligent manufacturing of Chinese medicine. The deep integration of artificial intelligence and advanced manufacturing technologies would spawn a new generation of intelligent manufacturing of Chinese medicine by realizing the application of process knowledge and model, as well as the closed loop of production process perception and control decision.

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