Xiong Hao-Shu, Zhang Qiang, Zhang Shun-Nan, Cai Jin-Yong, Su Jing, Zhu Yong-Hong, Yan Kai-Jing
National-Local Joint Engineering Laboratory of Advanced Traditional Chinese Medicine Manufacturing Technology, Tasly Pharmaceutical Group Co., Ltd. Tianjin 300410, China National Key Laboratory of Critical Technology in Innovative Chinese Medicine Tianjin 300410, China.
National-Local Joint Engineering Laboratory of Advanced Traditional Chinese Medicine Manufacturing Technology, Tasly Pharmaceutical Group Co., Ltd. Tianjin 300410, China.
Zhongguo Zhong Yao Za Zhi. 2023 Jan;48(1):22-29. doi: 10.19540/j.cnki.cjcmm.20220420.301.
Owing to the advancement in pharmaceutical technology, traditional Chinese medicine industry has seen rapid development. Preferring conventional manufacturing mode, pharmaceutical enterprises of traditional Chinese medicine have no effective process detection tools and process control methods. As a result, the quality of the final products mainly depends on testing and the quality is inconsistent in the same batch. Process analytical technology(PAT) for traditional Chinese medicine manufacturing, as one of the key advanced manufacturing techniques, can break through the bottleneck in quality control of medicine manufacturing, thus improving the production efficiency and product quality and reducing the material and energy consumption. It is applicable to the process control and real-time release of advanced manufacturing modes such as intelligent manufacturing and continuous manufacturing. This paper summarized the general idea of PAT for traditional Chinese medicine manufacturing. Through the analysis of the characteristics and status quo of the technology, we summed up the methodology for the continuous application and improvement of PAT during the whole life-cycle of traditional Chinese medicine. The five key procedures(process understanding, process detection, process modeling, process control, and continuous improvement) were summarized, and the application was reviewed. Finally, we proposed suggestions for the technical and regulatory challenges in implementing PAT in traditional Chinese medicine industry. This paper aims to provide a reference for development and application of PAT in advanced manufacturing, intelligent manufacturing, and continuous manufacturing of traditional Chinese medicine industry.
由于制药技术的进步，中药产业得到了快速发展。中药制药企业偏好传统制造模式，缺乏有效的过程检测工具和过程控制方法。因此，最终产品的质量主要依赖于检测，且同一批次的质量不一致。中药制造过程分析技术（PAT）作为关键的先进制造技术之一，能够突破药品制造质量控制的瓶颈，从而提高生产效率和产品质量，降低物料和能源消耗。它适用于智能制造和连续制造等先进制造模式的过程控制和实时放行。本文总结了中药制造PAT的总体思路。通过对该技术的特点和现状进行分析，总结了PAT在中药全生命周期中持续应用和改进的方法。归纳了五个关键程序（过程理解、过程检测、过程建模、过程控制和持续改进），并对其应用进行了综述。最后，针对中药行业实施PAT面临的技术和监管挑战提出了建议。本文旨在为PAT在中药产业先进制造、智能制造和连续制造中的发展与应用提供参考。
