中药配方颗粒临床应用国际专家共识  

International Expert Consensus on Clinical Application of TCM Formula Granules

作　　者：吴雄志 卞兆祥[2] 陈新宇[3] 冯奕斌[4] 高文远[5] 刘香春[6] 林展弘 商洪才[8] 时毓民[9] 孙长岗[10] 唐友明[11] 谢胜[12] 中药配方颗粒临床应用国际专家共识项目组 Xiong-Zhi Wu;Zhao-Xiang Bian;Xin-Yu Chen;Yi-Bin Feng;Wen-Yuan Gao;Xiang-Chun Liu;Zhan-Hong Lin;Hong-Cai Shang;Yu-Min Shi;Chang-Gang Sun;You-Ming Tang;Sheng Xie;Working Group of International Expert Consensus on Clinical Application of Traditional Chinese Medicine Formula Granules(Tianjin Hospital of ITCWM Nankai Hospital,Tianjin 300060,China;Hong Kong Baptist University,Hong Kong 999077,China;The First Hospital of Hunan University of Chinese Medicine,Changsha 410021,China;The University of Hong Kong,Hong Kong 999077,China;Tianjin University,Tianjin 300072,China;Qinghai Hospital of Traditional Chinese Medicine,Xining 810000,China;Chinese Medical Association(Taipei),Taipei 00129880,China;Dongzhimen Hospital Beijing University of Chinese Medicine,Beijing 100700,China;Children’s Hospital of Fudan University,Shanghai 201102,China;Shandong University of Traditional Chinese Medicine,Jinan 250355,China;Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine,Nanning 530399,China;The First Affiliated Hospital of Guangxi University of Chinese Medicine,Nanning 530023,China;不详)

机构地区：[1]天津南开医院,天津300060 [2]香港浸会大学,中国香港999077 [3]湖南中医药大学第一附属医院,长沙410021 [4]香港大学,中国香港999077 [5]天津大学,天津300072 [6]青海省中医院,西宁810000 [7]台北中医师公会,中国台北00129880 [8]北京东直门医院,北京100700 [9]复旦大学附属儿科医院,上海201102 [10]山东中医药大学,济南250355 [11]广西中医药大学附属瑞康医院,南宁530399 [12]广西中医药大学第一附属医院,南宁530023 [13]不详

出　　处：《TMR经典中医研究》2021年第1期19-26,共8页Classical Chinese Medicine Research

摘　　要：中药配方颗粒以中医药理论为指导,结合现代制剂新技术,选定最佳工艺,经现代化的制药技术提取、浓缩、干燥、制粒,精制而成。中药配方颗粒稳定、安全、便捷、有效。中药配方颗粒产业链相较于中药饮片可以实现从田间到车间的全程化、过程化控制,在药材来源、饮片炮制、加工工艺、质量检测、产品的销售流通等环节实现标准化管理。中药配方颗粒可部分替代中成药。目前中药配方颗粒仅涵盖常用的800余种中药,因此对许多临床并不常用的中药品种,中药配方颗粒并不能取代饮片。临床研究与动物实验中大量使用配方颗粒,从而使得科研人员不再对中药饮片进行提取与质量控制。应尽快从提高生产工艺、建立质量标准、完善监管制度、拓展临床应用等方面解决困扰配方颗粒发展所面临的问题。Guided by the theory of traditional Chinese medicine(TCM),TCM formula granules are made through the optimal process of extraction,concentration,drying,and granulation by combining modern new preparation technologies and pharmaceutical technologies.TCM formula granules are stable,safe,convenient,and effective.Compared with TCM decoction pieces,TCM formula granules can achieve the full process control of its industry chain from field to workshop and standardize the management of the origin of medicinal materials,processing of decoction pieces,processing technology,quality inspection,sales,and products distribution.TCM formula granules can partially replace Chinese patent medicines.Only available for around 800 common varieties of TCM,TCM formula granules cannot replace decoction pieces for many types which are not commonly used in clinical practice.A large number of formula granules are used in clinical and animal studies so that investigators no longer need to extract and control the quality of TCM decoction pieces.How to improve the production process,establish the quality standard,perfect the regulatory system,and expand the clinical application are the problems we need to solve as soon as possible for the better development of formula granules.

关 键 词：配方颗粒 中医药 安全性 稳定性 有效性 质量标准 

分 类 号：R28[医药卫生—中药学]