摘要
中药临方制剂进入快速发展阶段,建立完善的生产规范与质量控制体系是保证中药临方制剂健康、良性发展的关键。该文分析了中药临方制剂的特点,借鉴了代煎液和膏方的现行生产质量管理规范,考虑中药临方制剂生产中可能存在和发生的各种问题,提出适宜中药临方制剂的生产质量管理方案及安全生产注意事项,为中药临方制剂的生产规范与质量管理体系提供参考。临方制剂的生产规范及质量控制体系也应与时俱进,动态发展。未来,将临方生产与大数据、人工智能等现代技术相结合,在规范的GMP要求下,实现中药临方制剂的自动化、智能化生产,建立完善的质量追溯体系、在线控制策略、安全管理模式,将有效保证中药临方制剂的健康、良性发展。
Personalized traditional Chinese medicine(TCM)preparations have entered a stage of rapid development.The key to the healthy development of this industry is to establish a sound manufacturing standard and quality control system.This paper analyzed the characteristics of personalized TCM preparations and drew reference from the quality management standards in the production of commissioned decoctions and oral pastes,on the basis of which the production quality management scheme and cautions for the safe production of personalized TCM preparations was put forward with consideration to various problems that may exist and occur in the production of such preparations.It provided references for formulating the production standards and quality management system of personalized TCM preparations.The production standards and quality control system should develop with the times.In the future,modern technologies such as big data and artificial intelligence should be employed to achieve the automated and intelligent production and establish a sound quality traceability system,online control strategy,and safety management mode of personalized TCM preparations,which will ensure the healthy development of this industry under requirement of good manufacturing practice(GMP).
作者
王优杰
林晓
沈岚
张磊
洪燕龙
WANG You-jie;LIN Xiao;SHEN Lan;ZHANG Lei;HONG Yan-long(Innovation Research Institute of Traditional Chinese Medicine,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Engineering Research Center of Modern Preparation Technology of Traditional Chinese Medicine,Ministry of Education,Shanghai 201203,China;College of Chinese Materia Medica,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Shanghai Innovation Center of Traditional Chinese Medicine Health Service,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China)
出处
《中国中药杂志》
CAS
CSCD
北大核心
2024年第3期580-586,共7页
China Journal of Chinese Materia Medica
基金
国家自然科学基金项目(81973490)
上海市“科技创新行动计划”技术标准项目(20DZ2200900)
上海中医药慢性病防治与健康服务省部共建协同创新中心项目(2021科技02-37)
上海市自然科学基金项目(20ZR1458400,23ZR1463500)。
关键词
中药临方制剂
生产规范
质量控制
智能化生产
膏方
personalized traditional Chinese medicine preparations
manufacturing practice
quality control
intelligent production
oral paste
