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[中药固体制剂智能制造的现状、挑战与发展趋势]

[Current status, challenges, and development trends in intelligent manufacturing of traditional Chinese medicine solid preparations].

作者信息

Wang Zi-Qian, Li Yuan-Hui, Wang Xue-Cheng, Luo Xiao-Rong, Wang Le-Yun, Wan Yong, Wu Zhen-Feng

机构信息

Key Laboratory of Modern Preparations 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 Preparations of Traditional Chinese Medicine, Ministry of Education, Jiangxi University of Chinese Medicine Nanchang 330004, China National Key Laboratory of Creation of Modern Chinese Medicine with Classical Formulas Nanchang 330004, China.

出版信息

Zhongguo Zhong Yao Za Zhi. 2024 Oct;49(20):5674-5680. doi: 10.19540/j.cnki.cjcmm.20240716.302.

DOI:10.19540/j.cnki.cjcmm.20240716.302
PMID:39701749
Abstract

The intelligent manufacturing of traditional Chinese medicine(TCM) solid preparations is an important direction in the current development of the TCM industry. TCM enterprises are fervently pursuing intelligent manufacturing and digital transformation, and new equipment and technologies are empowering the development of this industry. With the rapid development of the global pharmaceutical market, the manufacturing level of large-scale drugs represents the advancement in the pharmaceutical industry of a country. Solid preparations, being a main dosage form of TCM, have complex and diverse manufacturing processes and stringent quality control requirements. A number of enterprises are seizing the opportunity to reshape their original drug manufacturing processes, making lean improvement in drug quality and achieving key breakthroughs in drug sensory perception, quality recognition, value transfer, and intelligent control. They are moving towards goals of energy saving, equipment synergy, and simultaneous improvement in quality and efficiency. Promoting the intelligent manufacturing of TCM solid preparations can not only improve the production efficiency and drug quality but also solve control challenges, being of significant practical importance and offering broad development prospects. By reviewing the recent policies and studies on TCM manufacturing in China, this paper analyzes the challenges, current status, and development trends in the intelligent manufacturing of TCM solid preparations, providing a reference for subsequent research in this field.

摘要

中药固体制剂的智能制造是当前中药产业发展的一个重要方向。中药企业正热切地追求智能制造和数字化转型,新设备和新技术正在推动该产业的发展。随着全球制药市场的快速发展,大规模药品的制造水平代表着一个国家制药行业的进步。固体制剂作为中药的主要剂型,其制造工艺复杂多样,质量控制要求严格。一些企业正抓住机遇重塑其原有的药品制造流程,在药品质量上进行精益改进,并在药品感官认知、质量识别、价值传递和智能控制方面取得关键突破。它们正朝着节能、设备协同以及质量和效率同步提升的目标迈进。推动中药固体制剂的智能制造不仅可以提高生产效率和药品质量,还能解决控制挑战,具有重大的现实意义并提供广阔的发展前景。通过回顾中国近期关于中药制造的政策和研究,本文分析了中药固体制剂智能制造中的挑战、现状和发展趋势,为该领域的后续研究提供参考。

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