摘要
中药新药研发已进入高质量发展与资源保障并举的新阶段。该文基于课题组参与18个中药新药注册资源评估项目的实践经验,系统梳理中药资源管理面临的三大核心挑战:首先,全产业链复杂性导致资源数量与质量风险叠加,体现于药材异质性(多基原差异、野生变家种引发的种源变迁)和产业环节耦合效应(种源-种植-加工全链条波动);其次,企业、科研与生产主体间的结构性错位,导致科研与产业需求脱节;最后,质量可控体系构建存在技术瓶颈,涉及产地变迁、栽培品种迭代、采收加工方式革新等关键因素。研究提出资源评估应聚焦“物种固定、数量可供、质量可控、质量选优”四维框架,建立涵盖多基原遴选、混伪品防控、濒危物种保护、种植技术标准化等要素的预警清单。针对进口药材和民族药材提出风险管控策略,强调建全产业链质量溯源体系的重要性。通过淫羊藿等典型案例,构建“优良种源+种植技术+质量控制”三位一体的产业提升范式,最终形成科研与产业深度协同的创新机制。研究建议通过加强科研与产业的深度协同,将资源评估从合规性审查升级为战略决策工具,推动中药产业从被动应对转向预见性管理,为中医药高质量发展提供资源保障。
The research and development of new traditional Chinese medicine(TCM)drugs has entered a phase integrating highquality development with resource assurance.Drawing from 18 new TCM drug registration resource assessment projects,this study systematically summarizes three core challenges in TCM resource management:O industrial chain complexity amplifies quantity-quality risks through material heterogeneity(multi-origin variations and wild-to-cultivated genetic shifts)and production chain coupling(germplasm-cultivation-processing whole-chain volatility);②structural misalignment among institutions,enterprises,and producers leads to disattachment of research and development from industrial demand;technical barriers exist in quality control systems,involving producing area shift,cultivation evolution,and harvesting and processing innovations.This study proposes a four-dimensional assessment framework prioritizing"species stabilization,quantity availability,quality control,and quality optimization",which is supported by an early-warning system addressing multi-origin selection,adulterant control,endangered species protection,and standardized cultivation.Risk management strategies emphasize supply chain traceability,particularly for imported and ethnic medicinal materials.Using Epimedi Folium as a case study,this study demonstrates a tripartite industrial upgrade paradigm integrating premium germplasm,cultivation technology,and quality control,ultimately establishing an innovation mechanism with deep academia-industry collaboration.The research advocates transforming resource assessment from compliance checks to strategic decision-making tools through enhanced academia-industry collaboration,so as to provide resource assurance for high-quality TCM development.
作者
郭宝林
潘诚
GUO Bao-lin;PAN Cheng(Institute of Medicinal Plant Development,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100193,China)
出处
《中国中药杂志》
北大核心
2025年第13期3556-3560,共5页
China Journal of Chinese Materia Medica
基金
中国医学科学院医学院健康科技创新工程项目(2021-I2M-1-031)。
关键词
中药资源评估
物种固定
数量可供
质量可控
质量选优
中药资源管理
产学研协同
traditional Chinese medicine resource assessment
species stabilization
quantity availability
quality control
quality optimization
management of traditional Chinese medicine resources
industry-academia-research collaboration
作者简介
通信作者:郭宝林,研究员,博士生导师,研究方向为中药资源、鉴定与栽培,E-mail:guobaolin010@163.com。
