中药质量安全是中医药产业可持续发展的生命线，构建中药溯源体系是解决中药材全链条质量管控难题、实现质量监管的核心手段，对维护道地药材品牌形象、规范药材市场秩序具有重要意义。目前，我国中药溯源体系已整合物联网、区块链、大数据、AI等关键技术，建成覆盖“种植、加工、流通、使用”的全链条信息管理系统，多地试点已验证其应用价值，行业进入多技术协同的稳定发展阶段。但现有研究与实践仍存在关键争议与不足：研发机构间信息维度差异大、追溯信息多环节不连通的技术协同问题，经营商自我监管意识薄弱的主体意识问题，信息采集成本高、中小主体参与门槛高的成本数据问题，以及全国统一数据标准缺失、监管机制不完善的行业规范问题，导致溯源系统覆盖范围有限，假冒伪劣药材仍存在，问题产品的源头回溯与召回能力亟待提升。系统梳理中药溯源体系的发展历程与政策演进，综述其核心功能、关键技术融合应用逻辑及典型试点成效，针对现阶段不足提出靶向优化建议；研究结构上从中药质量安全的“根源、放大、终极”逻辑链剖析问题，再阐述溯源体系的发展、建设现状，进而分析面临的挑战并提出可行性对策，最后展望未来发展方向。研究发现，中药溯源体系的建设需以标准化、智能化、普惠化、全球化为核心方向，通过制定统一元数据标准、深化多技术融合、构建“政府补贴＋保险联动＋品牌溢价”成本模型、健全多元共治监管机制，破解行业痛点。未来，应进一步聚焦不同品类中药材的差异化溯源方案、多技术融合的低成本落地路径、溯源数据与临床疗效的关联分析等方向，推动学术成果与产业应用深度结合，让中药溯源体系成为保障中药材质量安全、推动中医药传承创新发展的坚实支撑。

The quality and safety of Chinese medicinal materials are the lifeline for the sustainable development of the traditional Chinese medicine (TCM) industry. Establishing a traceability system for Chinese medicinal materials is a core means to solve the problem of whole-chain quality control and achieve quality supervision, which is of great significance for maintaining the brand image of authentic medicinal materials and regulating the order of the medicinal materials market. At present, China’s traceability system for Chinese medicinal materials has integrated key technologies such as the Internet of Things, blockchain, big data, and AI, and has built a full-chain information management system covering “cultivation-processing-circulation-use”. Pilot projects in multiple regions have verified its application value, and the industry has entered a stable development stage of multi-technology collaboration. However, existing research and practice still face key controversies and deficiencies: technical coordination problems such as large differences in information dimensions among research and development institutions and disconnected traceability information across multiple links, subject awareness problems such as weak self-supervision awareness among business operators, cost and data problems such as high information collection costs and high barriers to participation for small and medium-sized entities, and industry standardization problems such as the lack of unified national data standards and imperfect regulatory mechanisms. These issues lead to limited coverage of the traceability system, the continued existence of counterfeit and substandard medicinal materials, and an urgent need to enhance the ability to trace back to the source and recall problematic products. The purpose of this study is to systematically review the development history and policy evolution of the traceability system for Chinese medicinal materials, summarize its core functions, key technology integration application logic, and typical pilot achievements, and propose targeted optimization suggestions for current deficiencies. The research structure analyzes the problem from the “root-amplification-ultimate” logical chain of Chinese medicinal material quality safety, then elaborates on the development and construction status of the traceability system, subsequently analyzes the challenges faced and proposes feasible countermeasures, and finally looks forward to future development directions. The study finds that the construction of the traceability system for Chinese medicinal materials needs to focus on standardization, intelligence, inclusiveness, and globalization as core directions. By formulating unified metadata standards, deepening multi-technology integration, constructing a “government subsidies + insurance linkage + brand premium” cost model, and improving diversified co-governance regulatory mechanisms, industry pain points can be resolved. In the future, further focus should be placed on differentiated traceability schemes for different categories of Chinese medicinal materials, low-cost implementation paths for multi-technology integration, correlation analysis between traceability data and clinical efficacy, and other directions, to promote deep integration of academic achievements and industrial applications, making the traceability system for Chinese medicinal materials a solid support for ensuring the quality and safety of Chinese medicinal materials and promoting the inheritance, innovation, and development of TCM.

R282

国家自然科学基金面上项目（82174236）；四川省高等教育人才培养质量和教学改革项目（JG2024-0660）；四川省卫生信息学会科研课题（2025010）