Wang Zi-Qian, Wang Xue-Cheng, Zhong Zhi-Jian, Liu Zhen-Feng, Wang Ya-Qi, Yi Bing, Yang Ming, Zhu Wei-Feng, Wu Zhen-Feng
Key Laboratory of Modern Preparation of Traditional Chinese Medicine,Ministry of Education,Jiangxi University of Chinese Medicine Nanchang 330004,China Jiangxi Drug Inspection Center Nanchang 330000,China.
Key Laboratory of Modern Preparation of Traditional Chinese Medicine,Ministry of Education,Jiangxi University of Chinese Medicine Nanchang 330004,China.
Zhongguo Zhong Yao Za Zhi. 2023 Aug;48(16):4536-4544. doi: 10.19540/j.cnki.cjcmm.20230508.301.
In recent years, continuous manufacturing technology has attracted considerable attention in the pharmaceutical industry. This technology is highly sought after for its significant advantages in cost reduction, increased efficiency, and improved productivity, making it a growing trend in the future of the pharmaceutical industry. Compared to traditional batch production methods, continuous manufacturing technology features real-time control and environmentally friendly intelligence, enabling pharmaceutical companies to produce drugs more efficiently. However, the adoption of continuous manufacturing technology has been slow in the field of traditional Chinese medicine(TCM) pharmaceuticals. On the one hand, there is insufficient research on continuous manufacturing equipment and technology that align with the characteristics of TCM preparations. On the other hand, the scarcity of talent with diverse expertise hampers its development. Therefore, in order to promote the modernization and upgrading of the TCM pharmaceutical industry, this article combined the current development status of the TCM industry to outline the development status and regulatory requirements of continuous manufacturing technology. At the same time, it analyzed the problems with existing TCM manufacturing models and explored the prospects and challenges of applying continuous manufacturing technology in the field of TCM pharmaceuticals. The analysis focused on continuous manufacturing control strategies, technical tools, and pharmaceutical equipment, aiming to provide targeted recommendations to drive the development of the TCM pharmaceutical industry.
近年来，连续制造技术在制药行业备受关注。该技术因其在降低成本、提高效率和提升生产力方面的显著优势而备受追捧，成为制药行业未来的发展趋势。与传统的批量生产方法相比，连续制造技术具有实时控制和环境友好型智能的特点，使制药公司能够更高效地生产药品。然而，连续制造技术在中药制药领域的应用进展缓慢。一方面，针对符合中药制剂特点的连续制造设备和技术的研究不足。另一方面，具备多种专业知识的人才稀缺阻碍了其发展。因此，为推动中药制药行业的现代化升级，本文结合中药行业的当前发展状况，概述了连续制造技术的发展现状和监管要求。同时，分析了现有中药制造模式存在的问题，并探讨了在中药制药领域应用连续制造技术的前景和挑战。分析聚焦于连续制造控制策略、技术工具和制药设备，旨在提供有针对性的建议，以推动中药制药行业的发展。
