中药配方颗粒国家标准研究技术关注点探讨

2021年4月29日国家药典委员会颁布首批160个中药配方颗粒国家药品标准，历时5年的第一批中药配方颗粒国家药品标准研究工作正式落地。为了更好地推动后续中药配方颗粒新品种国家标准的研究，加快中药配方颗粒国家标准的制定，总结第一批中药配方颗粒国家药品标准研究的经验，从药材基原、产地代表性、饮片炮制、标准汤剂制备和成品工艺研究5个方面探讨中药配方颗粒国家标准研究过程中的技术关注点，为更合理地制定中药配方颗粒国家标准提供参考。

Technical Concerns of National Standard Research of Traditional Chinese Medicine Formula Granules

On April 29, 2021, the Chinese Pharmacopoeia Commission promulgated the national standards for the first batch of 160 varieties of traditional Chinese medicine (TCM) formula granules, declaring that the first batch of national standard research work for TCM formula granules which lasted for five years was officially implemented. To promote the follow-up research on the national standards of new varieties of TCM formula granules and accelerate the formulation of the standards, we summarized the experience of the first batch of national standard research and discussed the technical concerns in the research from five aspects: the origin of medicinal materials, the representativeness of producing areas, the processing of decoction pieces, the preparation of standard decoctions, and the process of finished product, so as to provide reference for the reasonable formulation of national standards of TCM formula granules.