首页|中药配方颗粒国家标准在临床应用中的现状、问题及对策

中药配方颗粒国家标准在临床应用中的现状、问题及对策

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按照国家药监局《结束中药配方颗粒试点工作的公告》要求,2021年11月开始执行中药配方颗粒国家标准。通过对临床使用中药配方颗粒国家标准现状的调研发现,目前存在以下问题:国家标准品种不能满足临床处方开具要求;与原企业标准相比,当量转化比差异大,导致调剂量大;缺乏临床使用指南。这些问题导致临床大夫开具处方困难,患者使用也不方便,甚至可能产生不良反应。因此,本文建议加大中药配方颗粒标准研制速度,开展中药配方颗粒质量评价与等效性等基础研究,并研制中药配方颗粒临床使用指南和标准。
Status Quo,Problems and Countermeasures of National Standard of Chinese Medicine Formulation Granules in Clinical Application
The implementation of the national standard for Chinese medicine formula particles started in November 2021 according to re-quirements of the Announcement on Ending the Pilot Work of Chinese Medicine Formula Particles by the State Drug Administration(SDA).Through the research on the current status of the national standard of Chinese medicine formulated particles for clinical use,it is found that the national standard varieties cannot meet the requirements of clinical prescription,the large difference in the equivalent conversion ratio compared with the original enterprise standard leads to a large amount of transfer,and there is no set of relevant guide-lines to guide the rational use of clinical use is a common problem in clinical practice,resulting in the inconvenience of clinical doctor's prescription and patient's use,and even producing adverse reactions.This paper proposes the ideas to speed the standardization of Chi-nese medicine formula particles,to carry out basic research on quality evaluation and equivalence of Chinese medicine formula particles and to develop guidelines and standards for clinical use of Chinese medicine formula particles.

Chinese medicine formula particlenational standardclinical applicationequivalence studyquality consistency evaluation methodclinical rational medicinal use

付红、陈小菲、吴瑞、李伟霞、张明亮、唐进法

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河南中医药大学第一附属医院药学部,河南郑州 450000

河南中医药大学药学院,河南郑州 450046

河南省中药临床应用、评价与转化工程研究中心/河南省中药临床药学中医药重点实验室/河南省中药安全评价与风险防控工程研究中心,河南郑州 450000

中药配方颗粒 国家标准 临床应用 等效性研究 质量一致性评价方法 临床合理用药

2025

中医学报
河南中医药大学,中华中医药学会

中医学报

影响因子:1.264
ISSN:1674-8999
年,卷(期):2025.40(1)