摘要
随着人们生活水平不断提高、生活节奏大幅加快,患者对中药药学服务的需求不断提高,临方制剂的使用数量正逐年递增。制剂技术的瓶颈、制剂规范的缺失等一系列问题逐渐显现出来,导致临方制剂的产品质量参差不齐,并且缺乏监管的法律依据。该文对中药临方制剂的剂型应用、制剂技术、生产设备、规范标准、临床应用以及服用模式的现状及存在问题,进行系统的总结与分析,提出基于制剂原料物理指纹图谱的中药临方制剂技术的传承与创新研究模式、"研究-专利-技术-设备-标准"的创新研究与知识产权保护模式、基于全过程可溯源的临方制剂生产规范体系以及基于工业4.0的临方制剂区域加工服务模式等创新发展对策,期望对推动中药临方制剂的传承与创新发展提供有益的参考。
With the continuous improvement of people′s living standards and the greatly accelerated pace of life, patients′ requirements for traditional Chinese medicine(TCM) pharmaceutical care are constantly raised, and personalized TCM preparations used are increasing year by year. However, a series of problems, such as the bottleneck of preparation technology, the lack of preparation specifications, and the weak legal basis for supervision, have become prominent, leading to the uneven product quality of personalized pre-parations. This paper systematically summarized and analyzed the current situation and existing problems of personalized TCM preparations, including dosage form application, preparation technology, production equipment, quality standard, clinical application, and administration mode. Additionally, it put forward an inheritance and innovation research mode of personalized TCM preparation technology based on the physical fingerprint of raw materials and innovation research and intellectual property protection mode of "research-patent-technology-equipment-standard". Furthermore, innovative development strategies were proposed, such as the production standard system of clinical preparations based on the whole process traceability and the regional processing service mode of clinical preparations based on industry 4.0. The present study is expected to provide beneficial references for the inheritance and innovation development of personalized TCM preparations.
作者
洪燕龙
王优杰
沈岚
林晓
刘雳
洪燕珠
张磊
HONG Yan-long;WANG You-jie;SHEN Lan;LIN Xiao;LIU Li;HONG Yan-zhu;ZHANG Lei(Shanghai Innovation Center of Traditional Chinese Medicine Health Service y Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Engineering Research Center of Modern Preparation Technology of Traditional Chinese Medicine,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;College of Chinese Materia Medica,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Shanghai Pharmaceuticals Holding Co.,Ltd.,Shanghai 200020,China;School of Medicine,Xiamen University,Xiamen 361005,China)
出处
《中国中药杂志》
CAS
CSCD
北大核心
2021年第15期3739-3745,共7页
China Journal of Chinese Materia Medica
基金
国家自然科学基金项目(81973490)
上海市自然科学基金项目(18ZR1436600,19ZR1457700,18ZR1439800)
上海市“科技创新行动计划”技术标准项目(20DZ2200900)
上海市卫生和计划生育委员会中医药事业发展三年行动计划项目[ZY(2018-2020)-CCCX-2001-03]
2021年度上海市协同创新中心建设项目(2021科技01-01-30)。
关键词
中药临方制剂
应用现状
发展对策
工业4.0
personalized traditional Chinese medicine(TCM)preparations
application
development strategies
industry 4.0
