作为传统中药饮片的现代化剂型，中药配方颗粒在地方标准中的结构性矛盾，已成为制约该产业高质量发展的关键障碍。研究发现，地方标准在来源、制法、性状、鉴别、特征图谱及含量测定等关键要素上存在较显著的地域差异，其根源在于药材资源分布差异、配套政策执行力度不同、监管效能及科研水平不均衡等。地方标准的分散化直接导致跨省流通壁垒、质量稳定性不足及监管矛盾等问题。基于此，提出“技术赋能＋协同治理”整合路径的解决方案：通过构建国家级技术共享平台、推进开展技术下沉及实施标准动态更新机制，借助技术力量弥补区域能力差距；同时借由跨区域协调委员会、标准互认试点及多元主体协同参与，促进监管协同与标准统一。通过以上解决方案，为我国现行中药配方颗粒标准体系提供理论创新与实践路径，对提升中药配方颗粒标准化治理能力具有政策参考价值。

Traditional Chinese medicinal formula granules (TCMFGs), as modernised preparations derived from traditional Chinese medicinal decoction pieces, are facing significant barriers to achieving high-quality industrial development due to structural contradictions of provincial standards. This study identifies significant interregional discrepancies in key parameters such as botanical origin, preparation methods, morphological identification, chromatographic fingerprinting and quantitative assays. These discrepancies are attributed to regional imbalances in medicinal resources, inconsistent policy implementations, uneven regulatory capacities and in R&D investment. This fragmentation of provincial standards impedes TCMFGs interprovincial circulation, exacerbates quality inconsistencies, and creates regulatory conflicts. This study proposes a dual-pathway approach integrating technological empowerment and collaborative governance. To bridge the regional disparities, this study recommends building national platforms for technology-sharing, facilitating primary-level institutes with better testing capacities, and implementing a dynamic standard renewal mechanism. To promote the regulatory coordination and the integration of provincial standards, this study advocates the establishment of interregional coordination committees, pilot projects for mutual standard recognition, and the participation of multiple stakeholders. This study intends to provide theoretical insights and practical pathways for the current TCMFGs standard system, thereby contributing to the governance of TCMFGs standardization with policy value.

R288

重庆市科技局决策咨询与制度创新项目（CSTB2022TFII-OIX0017）