[Research progress and maturity assessment of continuous manufacturing of traditional Chinese medicine].

Zhongguo Zhong Yao Za Zhi

Department of Chinese Medicine Informatics, Beijing University of Chinese Medicine Beijing 102400, China Beijing Key Laboratory for Production Process Control and Quality Evaluation of Traditional Chinese Medicine, Beijing Municipal Science & Technology Commission Beijing 102400, China Engineering Research Center of Chinese Medicine Production and New Drug Development, Ministry of Education of People's Republic of China Beijing 102400, China.

Published: June 2023

AI Article Synopsis

  • The shift in pharmaceutical manufacturing is moving towards continuous and intelligent processes, particularly in traditional Chinese medicine (TCM), enhancing efficiency and quality consistency.
  • Key technologies like material property characterization and process modeling are crucial for developing continuous manufacturing systems in TCM, emphasizing the need for high-speed, reliable equipment.
  • A maturity assessment model focusing on operation, equipment, process, and quality control continuity is proposed to guide the effective application of continuous manufacturing in TCM.

Article Abstract

The pharmaceutical manufacturing model is gradually changing from intermittent manufacturing to continuous manufacturing and intelligent manufacturing. This paper briefly reviewed the supervision and research progress in continuous pharmaceutical manufacturing in China and abroad and described the definition and advantages of continuous pharmaceutical manufacturing. The continuous manufacturing of traditional Chinese medicine(TCM) at the current stage was summarized in the following three terms: the enhancement of the continuity of intermittent manufacturing operations, the integration of continuous equipment to improve physical continuity between units, and the application of advanced process control strategies to improve process continuity. To achieve continuous manufacturing of TCM, the corresponding key technologies, such as material property characterization, process modeling and simulation, process analysis technology, and system integration, were analyzed from the process and equipment, respectively. It was proposed that the continuous manufacturing equipment system should have the characteristics of high speed, high response, and high reliability, "three high(H~3)" for short. Considering the characteristics and current situation of TCM manufacturing, based on the two dimensions of product quality control and production efficiency, a maturity assessment model for continuous manufacturing of TCM, consisting of operation continuity, equipment continuity, process continuity, and quality control continuity, was proposed to provide references for the application of continuous manufacturing technology for TCM. The implementation of continuous manufacturing or the application of key continuous manufacturing technologies in TCM can help to systematically integrate advanced pharmaceutical technology elements and promote the uniformity of TCM quality and the improvement of production efficiency.

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http://dx.doi.org/10.19540/j.cnki.cjcmm.20230228.301DOI Listing

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