[资源评估作为协作桥梁:解决中医药研究和产业中的困境,促进共生]。

Q3 Pharmacology, Toxicology and Pharmaceutics
Bao-Lin Guo, Cheng Pan
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引用次数: 0

摘要

中药新药研发已进入高质量发展与资源保障相结合的阶段。本研究以18个中药新药注册资源评估项目为例,系统总结了中药资源管理面临的三大核心挑战:(1)产业链复杂性通过物质异质性(多源变异和野生到栽培的遗传转移)和生产链耦合(种质-栽培-加工全链波动)放大了数量-质量风险;(2)机构、企业和生产者之间的结构性错位导致研发脱离产业需求;(3)产区转移、栽培演变、采收加工创新等质量控制体系存在技术壁垒。本研究提出了一个以“物种稳定、数量可用性、质量控制和质量优化”为优先级的四维评价框架,并以多产地选择、掺假控制、濒危物种保护和标准化栽培等预警系统为支撑。风险管理策略强调供应链的可追溯性,特别是对进口和民族药材。本文以淫羊藿(Epimedii Folium)为例,论证了优质种质、栽培技术和质量控制三者相结合的产业升级范式,最终构建了产学研深度合作的产业创新机制。本研究主张通过加强产学研合作,将资源评估从合规检查转变为战略决策工具,为中医药高质量发展提供资源保障。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
[Resource assessment as collaborative bridge: resolving dilemmas and fostering symbiosis in traditional Chinese medicine research and industry].

The research and development of new traditional Chinese medicine(TCM) drugs has entered a phase integrating high-quality 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:(1) 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);(2) structural misalignment among institutions, enterprises, and producers leads to disattachment of research and development from industrial demand;(3) 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 Epimedii 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.

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来源期刊
Zhongguo Zhongyao Zazhi
Zhongguo Zhongyao Zazhi Pharmacology, Toxicology and Pharmaceutics-Pharmacology, Toxicology and Pharmaceutics (all)
CiteScore
1.50
自引率
0.00%
发文量
581
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