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.
关键词
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
Key words
Chinese medicine formula particle/national standard/clinical application/equivalence study/quality consistency evaluation method/clinical rational medicinal use
维普
万方数据