通过参考《中国药典》2015年版和相关文献，结合国家药典委员会2016年发布的《中药配方颗粒质量控制与标准制定技术要求（征求意见稿）》，综合考虑中药配方颗粒的实际生产情况，对《关于中药配方颗粒品种试点统一标准的公示》中质量标准特异性、定量检测指标的选择和指标性成分转移率等方面进行讨论，根据讨论结果为中药配方颗粒质量标准的完善和提高提出了相关建议，为推进配方颗粒产业健康发展提供参考。

By referring to Chinese Pharmacopoeia 2015 edition and relevant literatures, combining the Technical Requirements for Quality Control and Standard Formulation of Traditional Chinese Medicine Formula Granules (Draft for Comments) issued by China Pharmacopoeia Committee in 2016, and considering the actual production situation of formula granules, the specificity of quality standards, the selection of quantitative detection indexes, index component transfer rate and other aspects in the Publicity of Uniform Standards for Trial Use of Traditional Chinese Medicine Formula Granules were comprehensively discussed. According to the results of the discussion, relevant suggestions are put forward for the development and improvement of the quality standard of traditional Chinese medicine formula granules, which provides reference for promoting the healthy development of formula granule industry.

R283.627

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