《中药材生产质量管理规范》修订背景及主要修订内容  

Revision Background and Main Contents of Good Agricultural Practice for Traditional Chinese Medicinal Materials

作　　者：魏建和 王文全[1] 王秋玲 乔旭 陈君 徐常青 隋春 刘赛 纪宏亮 王苗苗 金钺 金江群 田婷[3] 郭欣慰 杨成民 苏昆 陈颖 杨小玉 辛元尧 WEI Jian-he;WANG Wen-quan;WANG Qiu-ling;QIAO Xu;CHEN Jun;XU Chang-qing;SUI Chun;LIU Sai;JI Hong-liang;WANG Miao-miao;JIN Yue;JIN Jiang-qun;TIAN Ting;GUO Xin-wei;YANG Cheng-min;SU Kun;CHEN Ying;YANG Xiao-yu;XIN Yuan-yao(Key Laboratory of Bioactive Substances and Resources Utilization of Chinese Herbal Medicine,Ministry of Education&National Engineering Laboratory for Breeding of Endangered Medicinal Materials,Institute of Medicinal Plant Development,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100193,China;Hainan Provincial Key Laboratory of Resources Conservation and Development of Southern Medicine&Key Laboratory of National Administration of Traditional Chinese Medicine for Agarwood Sustainable Utilization,Hainan Branch of the Institute of Medicinal Plant Development,Chinese Academy of Medical Sciences and Peking Union Medical College,Haikou 570311,China;Institute of Medicine Plantation of Chongqing,Chongqing 408435,China)

机构地区：[1]中国医学科学院北京协和医学院药用植物研究所/中草药物质基础与资源利用教育部重点实验室/濒危药材繁育国家工程实验室,北京100193 [2]中国医学科学院北京协和医学院药用植物研究所海南分所/海南省南药资源保护与开发重点实验室/国家中医药管理局沉香可持续利用重点研究室,海南海口570311 [3]重庆市药物种植研究所,重庆408435

出　　处：《中国现代中药》2022年第5期743-751,共9页Modern Chinese Medicine

基　　金：中国医学科学院医学与健康科技创新工程项目(2021-I2M-1-032);财政部和农业农村部:国家现代农业产业技术体系项目;国家药品监督管理局委托研究课题(2019年);国家中医药管理局委托办事课题(GZY-KJS-2018-016-01)。

摘　　要：为更好地理解和贯彻新发布的《中药材生产质量管理规范》(以下简称新版中药材GAP)、促进中药材GAP规范化生产基地建设、推动中药高质量发展,浅谈新版中药材GAP修订背景、过程、主要修订思路、业界关注重点问题的处理及需要进一步细化的内容。新版中药材GAP共14章144条,较试行版中药材GAP增加了4章87条;修订中贯彻的主要思路包括强调对中药材质量有重大影响的关键环节实施重点管理、重视全过程细化管理、以“六统一”和“可追溯”树立风险管控理念;强调高标准、严要求、兼顾中药材生产实际情况及当前技术水平;贯彻“写我要做、做我所写、记我所做”理念,将技术规程和质量标准制定前置;立足中医药特色和传承,鼓励采用适宜的新技术、新方法;强调药材规范生产与生态环境保护统一;强化药材流向管理,补充了放行、投诉、退货与召回等管理内容。修订中,重点关注的问题包括新版中药材GAP的适用范围,“六统一”,生产组织方式,产地,种质,农药使用,壮根灵、膨大素等生长调节剂的使用,硫黄熏蒸与磷化铝熏蒸,技术规程与标准操作规程,中药材生产质量追溯体系,批等。In order to facilitate understanding the recently released Good Agricultural Practice for Traditional Chinese Medicinal Materials(new version GAP,nGAP),this paper analyzes the revision background,process,main ideas of revisions and treatment of key concerns for nGAP,which is expected to promote the construction of GAP base of traditional Chinese medicinal materials(TCMM)and high-quality development of traditional Chinese medicine(TCM).Those needed to be further refined in the Guide of the new version GAP are also discussed.nGAP is composed of 14 chapters and 144 articles,with 4 chapters and 87 articles added compared with the trial version GAP.The main ideas implemented in the revision are illustrated as follows.Importance is attached to detailed management of the whole process and key management on crucial links that impact the quality of TCMM,and the risk control concept of"six unification"and"traceability"is established.High standards and strict requirements are combined with the current situation and technical levels of TCMM production.Technical regulations and quality standards are formulated in advance by implementing the idea of"planning-implementing-review".Given the characteristics and inheritance of TCM,new technologies and new methods are encouraged.Standardized production of TCMM is unified with ecological environment protection.Moreover,goods direction management of TCMM is strengthened,and management contents such as release,complaint,return and recall of TCMM are added.Some key concerns in nGAP are as follows:the applicable targets of nGAP,"six unification",production and organization model,production sites,germplasm,pesticide use,the use of growth regulators,fumigation of sulfur and aluminum phosphide,technical procedures and standard operating procedures,production quality traceability system,batch,etc.

关 键 词：新版《中药材生产质量管理规范》 中药材生产 规范化 质量管理 修订背景 修订思路 

分 类 号：R282[医药卫生—中药学]