珍稀濒危中药材替代品及提取物投料相关监管科学问题探讨  

Discussion on Regulatory Science Issues Related to Substitutes of Rare and Endangered Chinese Medicinal Materials and Extract Feeding

作　　者：张俊华[1] 庾石山 张伯礼[1] 陈士林[3] 王海南 周思源 马双成 于江泳 张卫东 肖小河 屠鹏飞[9] 钱忠直[6] 果德安 王喜军[11] 程翼宇[12] 高月 王峥涛[14] 孙晓波[7] 李萍[15] 谢晓余 王停[17] 杨忠奇[18] 唐健元 元唯安[20] 华桦 周水平 刘雳 王勇 王磊 宋新波 黄宇虹[27] 张胜昔 刘春 阳长明 马秀璟 黄芳华 魏锋[30] 宋海波 海程玮 赵军宁 ZHANG Junhua;YU Shishan;ZHANG Boli;CHEN Shilin;WANG Hainan;ZHOU Siyuan;MA Shuangcheng;YU Jiangyong;ZHANG Weidong;XIAO Xiaohe;TU Pengfei;QIAN Zhongzhi;GUO De'an;WANG Xijun;CHENG Yiyu;GAO Yue;WANG Zhengtao;SUN Xiaobo;LI Ping;XIE Xiaoyu;WANG Ting;YANG Zhongqi;TANG Jianyuan;YUAN Wei'an;HUA Hua;ZHOU Shuiping;LIU Li;WANG Yong;WANG Lei;SONG Xinbo;HUANG Yuhong;ZHANG Shengxi;LIU Chun;YANG Changming;MA Xiujing;HUANG Fanghua;WEI Feng;SONG Haibo;HAI Chengwei;ZHAO Junning(Tianjin University of Traditional Chinese Medicine,Tianjin 301617;Institute of Materia Medica,Chinese Academy of Medical Sciences,Beijing 100700;Chengdu University of Traditional Chinese Medicine,Chengdu 610072;Department of Drug Registration,National Medical Products Administration,Beijing 100037;Center for Drug Evaluation,National Medical Products Administration,Beijing 100076;Chinese Pharmacopoeia Committee,Beijing 100061;Institute of Medicinal Plant Development,Chinese Academy of Medical Sciences,Beijing 100193;Traditional Chinese Medicine Research Institute,PLA General Hospital,Beijing 100089;Peking University,Beijing 100871;Shanghai Institute of Materia Medica,Chinese Academy of Sciences,Shanghai 200003;Heilongjiang University of Chinese Medicine,Haerbin 150040;Zhejang University,Hangzhou 310027;Academy of Military Medical Sciences,PLA,Beijing 100850;Shanghai University of Traditional Chinese Medicine,Shanghai 201203;China Pharmaceutical University,Nanjng 210009;Traditional Chinese Medicine Regulatory Science Research Center,China Academy of Chinese Medical Sciences,Beijing 100700;Beijing University of Chinese Medicine,Beijing 100029;The First Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510000;Affiliated Hospital of Chengdu University of Traditional Chinese Medicine,Chengdu 610072;Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 201203;Sichuan Institute for Translational Chinese Medicine,Chengdu 610041;Tasly Research Institute,Tianjin 300000;Shanghai Pharmaceuticals Holding Co.,L

机构地区：[1]天津中医药大学,天津301617 [2]中国医学科学院药物研究所,北京100700 [3]成都中医药大学,成都610072 [4]国家药品监督管理局药品注册司,北京100037 [5]国家药品监督管理局药品审评中心,北京100076 [6]国家药典委员会,北京100061 [7]中国医学科学院药用植物研究所,北京100193 [8]中国人民解放军总医院中药研究所,北京100089 [9]北京大学,北京100871 [10]中国科学院上海药物研究所,上海手2200003 [11]黑龙江中医药大学,哈尔滨150040 [12]浙江大学,杭州州310027 [13]中国人民解放军军事医学科学院,北京京100850 [14]上海中医药大学,上海201203 [15]中国药科大学,南京210009 [16]中国中医科学院中药监管科学研究中心,北京100700 [17]北京中医药大学,北京100029 [18]广州中医药大学第一附属医院,广州510000 [19]成都中医药大学附属医院,成都阝610072 [20]上海中医药大学附属曙光医院,上海2201203 [21]四川省中医药转化医学中心,成都610041 [22]天士力研究院,天津300000 [23]上海医药集团股份有限公司,上海200020 [24]华润三九医药股份有限公司,深圳518000 [25]津药达仁堂集团股份有限公司,天津300110 [26]现代中药创新中心,天津300384 [27]天津中医药大学第二附属医院,天津300250 [28]天津市药品监督管理局,天津301799 [29]国家药品监督管理局药品监管司,北京京100037 [30]中国食品药品检定研究院中药民族药检定所,北京102629 [31]国家药品监督管理局药品评价中心,北京100037 [32]国家药品监督管理局综合和规划财务司,北京100000 [33]国家药品监督管理局、药品监管科学全国重点实验室,北京100037

出　　处：《中药药理与临床》2025年第1期6-12,共7页Pharmacology and Clinics of Chinese Materia Medica

摘　　要：中药监管科学研究者联盟(TCM Regulatory Science Coalition, TCMRSC)工作机制第一次专题工作会议(TCMRSC24-1)于2024年2月26日在天津召开。本次会议由天津中医药大学现代中药创制全国重点实验室和现代中医药海河实验室联合承办,主题为“珍稀濒危药材替代品”和“中药提取物投料”相关监管科学问题研究。天津中医药大学张伯礼院士主持会议。会议分为背景介绍、主旨报告、专题研讨、会议总结四个部分进行。第一部分由国家药品监督管理局赵军宁研究员、药品注册司副司长王海南进行背景介绍。第二部分由成都中医药大学陈士林院士主持,中国医学科学院药物研究所副所长庾石山教授、天津中医药大学副校长张俊华教授进行主旨报告,分享了珍稀濒危中药材替代品相关监管科学研究及提取物投料相关监管科学研究已取得的成果和需要深化讨论的关键问题。第三部分由来自政府部门、高校、科研院所、临床医院、企业等机构的30余名专家围绕会议主题进行了专题研讨。第四部分张伯礼院士进行专题研讨总结。与会专家围绕监管中的相关科学问题进行了广泛深入讨论,本文整理了专家们的主要观点和建议,希望能为珍稀濒危中药材替代品及提取物投料创新研究与科学监管提供新思路和新方法。The first working meeting of the TCM Regulatory Science Coalition( TCMRSC24-1) was held on February 26,2024 in Tianjin. The meeting was jointly organized by the State Key Laboratory of Chinese Medicine Modernization,Tianjin University of Traditional Chinese Medicine and the Haihe Laboratory of Modern Chinese Medicine. The meeting focused on the regulatory science issues related to substitutes for rare and endangered Chinese medicinal materials and TCM extract feeding. Academician Zhang Boli from Tianjin University of Traditional Chinese Medicine chaired the meeting. The meeting encompassed four sections: background introduction,keynote presentations,thematic discussions,and a concluding summary. The first section featured an introduction to the background by Professor Zhao Junning from the National Medical Products Administration and Deputy Director Wang Hainan from the Department of Drug Registration. The second section,chaired by Academician Chen Shilin from Chengdu University of Traditional Chinese Medicine,included keynote presentations by Professor Yu Shishan,Vice Director of the Institute of Medicinal Plant Development,Chinese Academy of Medical Sciences,and Professor Zhang Junhua,Vice President of Tianjin University of Traditional Chinese Medicine. They shared academic achievements and key points related to regulatory science research on substitutes for rare and endangered Chinese medicinal materials and extract feeding. In the third section,over 30 experts from government departments,universities,research institutes,hospitals,and enterprises participated in discussions on the themes. The fourth section concluded with a summary of the thematic discussions by Academician Zhang Boli. The experts at the meeting engaged in extensive and in-depth discussions on relevant scientific issues in regulation. This article summarizes their key points and suggestions,aiming to provide new ideas and new methods for innovative research and scientific regulation of rare and endangered Chinese medicinal materials and extrac

关 键 词：中药提取物投料 珍稀濒危中药材替代品 中药监管科学 中药监管科学研究者联盟 

分 类 号：R288[医药卫生—中药学]