中药配方颗粒趋势分析与监管策略的思考

Trend analysis and regulatory strategies for traditional Chinese medicine formula granules

随着中药配方颗粒“后试点时代”的到来,当前在其生产、监管、应用实践中,仍面临着一系列的政策、技术、产业问题。该文通过系统梳理中药配方颗粒的发展历程和相关政策沿革;并从质量标准、医保支付、市场格局等方面归纳了其产业现状;基于中药配方颗粒与传统饮片对比分析与定位探讨。认为当前该领域还存在以下现实问题:(1)尚未形成合理的竞争演化机制,产品“提质增效”困难;(2)国家标准数量有限,地方标准各自为战;(3)生产工艺相对受限;(4)固定当量与原料波动的矛盾;(5)市场定位待明确,用药场景局限。进而,基于塑造良性中药产业生态和促进中医临床合理用药视角,提出了相关建议:(1)引导中药配方颗粒形成按产品竞争格局;(2)推动建立中药配方颗粒全过程监管体系;(3)系统研究配方颗粒当量与摄入量关系;(4)突破应用场景,合理拓展配方颗粒应用形式。

With the advent of the"post-pilot era"of traditional Chinese medicine formula granules,there are still a series of policy,technical,and industrial issues that need to be addressed in their production,regulation,and application practices.This article systematically reviews the development history and relevant policy evolution of traditional Chinese medicine formula granules,and summarizes the current industrial status in terms of quality standards,medical insurance payments,and market landscape.Based on a comparative analysis and positioning discussion between traditional Chinese medicine formula granules and traditional herbal decoctions,it is believed that the following practical issues still exist in this field:(1)A reasonable competitive evolution mechanism has not yet been formed,making it difficult to"improve quality and efficiency"of products;(2)The number of national standards is limited,and local standards operate independently;(3)Production processes are relatively constrained;(4)There is a contradiction between fixed equivalents and fluctuations in raw materials;(5)Market positioning needs to be clarified,and medication scenarios are limited.Furthermore,based on the perspective of shaping a healthy ecosystem for the traditional Chinese medicine industry and promoting rational clinical use of traditional Chinese medicine,the following suggestions are put forward:(1)Guide the formation of a product-based competitive landscape for traditional Chinese medicine formula granules;(2)Promote the establishment of a comprehensive regulatory system for the entire production process of traditional Chinese medicine formula granules;(3)Conduct systematic research on the relationship between the equivalents and intake of formula granules;(4)Break through existing application scenarios and reasonably expand the application forms of formula granules.