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智慧监管在中药制药标准操作程序中的应用
缪培琪1,2, 岑世欣1,2, 李正1,2,3
1.天津中医药大学中药制药工程学院, 天津 301617;2.天津市中药智能制药与绿色制药重点实验室, 天津 301617;3.现代中医药海河实验室, 天津 301617
摘要:
随着中药行业快速发展,智慧监管与标准操作程序(SOP)的融合成为提升产品质量与安全性的关键。文章深入探讨智慧监管技术在中药SOP中的应用,并对其未来发展进行展望。文章回顾了传统SOP的实施现状,分析其面临的挑战,例如人工操作的不规范性和监管效率等方面的不足。介绍物联网、人工智能和大数据分析等智慧监管核心技术,及其如何优化生产流程。通过案例分析,文章展示了智慧监管在提高“七步洗手法”合规率方面的成效,强调行业标准化与技术创新在未来中药生产SOP中的重要性,旨在为中药行业的可持续发展提供理论支持和实践指导。
关键词:  智慧监管  中药制药  标准操作程序  七步洗手法
DOI:10.11656/j.issn.1673-9043.2025.01.12
分类号:R2-03
基金项目:现代中药新质生产力科技创新工程专项项目(24ZXZKSY00010);天津中医药大学雏鹰计划项目(XJS2023205)。
The application of intelligent supervision in the standard operating procedure of traditional Chinese medicine pharmaceutical manufacturing
MIAO Peiqi1,2, CEN Shixin1,2, LI Zheng1,2,3
1.College of Pharmaceutical Engineering of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China;2.Tianjin Key Laboratory of Intelligent and Green Pharmaceuticals for Traditional Chinese Medicine, Tianjin 301617, China;3.Haihe Laboratory of Modern Chinese Medicine, Tianjin 301617, China
Abstract:
With the rapid development of the traditional Chinese medicine(TCM) industry,the integration of intelligent supervision and standard operating procedure(SOP) has become a key factor in improving product quality and safety. This paper explores the application of intelligent supervision technologies within TCM SOP and offers a forward-looking perspective on their future development. It reviews the current state of traditional SOP implementation and analyzes the challenges it faces,such as inconsistencies in manual operations and inefficiencies in supervision. The paper introduces core intelligent supervision technologies,including the Internet of Things(IoT),artificial intelligence(AI),and big data analytics,and illustrates how these technologies optimize production processes. Through case studies,it demonstrates the effectiveness of intelligent supervision in increasing compliance with practices such as the “seven-step handwashing method”,highlighting the importance of industry standardization and technological innovation in future TCM production SOP. The aim is to provide theoretical support and practical guidance for the sustainable development of the TCM industry.
Key words:  intelligent supervision  traditional Chinese medicine pharmaceutical manufacturing  standard operating procedure  seven-step handwashing method
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