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