作為傳統(tǒng)中藥飲片的現(xiàn)代化劑型，中藥配方顆粒在地方標(biāo)準(zhǔn)中的結(jié)構(gòu)性矛盾，已成為制約該產(chǎn)業(yè)高質(zhì)量發(fā)展的關(guān)鍵障礙。研究發(fā)現(xiàn)，地方標(biāo)準(zhǔn)在來源、制法、性狀、鑒別、特征圖譜及含量測定等關(guān)鍵要素上存在較顯著的地域差異，其根源在于藥材資源分布差異、配套政策執(zhí)行力度不同、監(jiān)管效能及科研水平不均衡等。地方標(biāo)準(zhǔn)的分散化直接導(dǎo)致跨省流通壁壘、質(zhì)量穩(wěn)定性不足及監(jiān)管矛盾等問題。基于此，提出“技術(shù)賦能＋協(xié)同治理”整合路徑的解決方案：通過構(gòu)建國家級(jí)技術(shù)共享平臺(tái)、推進(jìn)開展技術(shù)下沉及實(shí)施標(biāo)準(zhǔn)動(dòng)態(tài)更新機(jī)制，借助技術(shù)力量彌補(bǔ)區(qū)域能力差距；同時(shí)借由跨區(qū)域協(xié)調(diào)委員會(huì)、標(biāo)準(zhǔn)互認(rèn)試點(diǎn)及多元主體協(xié)同參與，促進(jìn)監(jiān)管協(xié)同與標(biāo)準(zhǔn)統(tǒng)一。通過以上解決方案，為我國現(xiàn)行中藥配方顆粒標(biāo)準(zhǔn)體系提供理論創(chuàng)新與實(shí)踐路徑，對(duì)提升中藥配方顆粒標(biāo)準(zhǔn)化治理能力具有政策參考價(jià)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

重慶市科技局決策咨詢與制度創(chuàng)新項(xiàng)目（CSTB2022TFII-OIX0017）