古代经典名方中药复方制剂概述与开发初探  

Overview and Preliminary Exploration of the Development of Traditional Chinese Medicine Compound Prescriptions in Ancient Classical Prescriptions

作　　者：熊晓妹 吴欢欢 黄怡 冯芸 朱圣姬 杨婷 李莉娥 李禹琼 Xiong Xiaomei;Wu Huanhuan;Huang Yi;Feng Yun;Zhu Shengji;Yang Ting;Li Lie;Li Yuqiong(Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.,Wuhan 430075,China;Wuhan Humanwell Innovative Drug Research and Development Center Co.,Ltd.,Wuhan 430075,China;Wuhan Optical Valley Humanwell Biological Pharmaceutical Co.,Ltd.,Wuhan 430075,China;Humanwell Healthcare(Group)Co.,Ltd.,Wuhan 430075,China)

机构地区：[1]湖北生物医药产业技术研究院有限公司,湖北武汉430075 [2]武汉人福创新药物研发中心有限公司,湖北武汉430075 [3]武汉光谷人福生物医药有限公司,湖北武汉430075 [4]人福医药集团股份公司,湖北武汉430075

出　　处：《亚太传统医药》2024年第12期6-11,共6页Asia-Pacific Traditional Medicine

摘　　要：古代经典名方中药复方制剂是中医药理论历经时代洗礼沉淀下来的精华,是中华民族中医药文化宝库中的杰出代表。开发古代经典名方中药复方制剂,是传承精华、守正创新的重大举措,具有重要的现实意义。近几年来国家政策重点鼓励中药传承与创新发展,传统中药古代经典名方申报和审评审批速度明显加快,古代经典名方的研发热度持续高涨。通过系统梳理古代经典名方中药复方制剂当前的国家政策、申报和审批情况,以及从法规的角度介绍古代经典名方中药复方制剂药学、非临床和临床方面的研发要求,并简要介绍当前国家药品监督管理局药品审评中心关于古代经典名方中药复方制剂的审评和审批制度,以抛砖引玉,为古代经典名方从方剂成功转化成中药新药提供借鉴和参考。Traditional Chinese medicine compound preparations are the essence of the theory of traditional Chinese medicine after the times of baptism and precipitation,and is an outstanding representative of the treasure house of Chinese traditional Chinese medicine culture.The development of traditional Chinese medicine compound preparations,which are classic and famous in ancient times,is a major measure to inherit the essence and keep the integrity and innovation,and has important practical significance.In recent years,national policies have focused on encouraging the inheritance and innovative development of traditional Chinese medicine.The speed of application,review and approval for ancient classic prescriptions of traditional Chinese medicine has significantly accelerated,and the research and development enthusiasm for ancient classic prescriptions continues to soar.This article systematically reviews the current national policies,applications,and approvals of ancient classic Chinese medicine compound formulations,as well as introduces the research and development requirements for pharmaceutical,non-clinical,and clinical aspects of ancient classic Chinese medicine compound formulations from a regulatory perspective.And briefly introduce the current evaluation and approval system of the Center for Drug Evaluationg on Traditional Chinese medicine compound preparations in ancient classical prescriptions,in order to provide reference and inspiration for the successful transformation of ancient classic formulas from formulas to innovative traditional Chinese medicine.

关 键 词：中药 古代经典名方 传承与创新 审评机制 开发探讨 

分 类 号：R283[医药卫生—中药学]