Analysis and synopsis of the assessment of formula granule, a provincial traditional Chinese medicine

Summarize the standards of traditional Chinese medicine formula granules issued by the National Medical Products Administration and various provinces, and keep track of the progress of the revision of the standards of traditional Chinese medicine formula granules in each province. Through a comprehensive analysis of the 179 varieties included in the published and compiled Anhui Provincial Traditional Chinese Medicine Formula Granules, this study evaluates multiple aspects, including origin selection, raw material sources, standard decoction preparation processes, control limits for heavy metals, harmful elements, and aflatoxin contamination, as well as efficacy assessments. This study aims to develop a comprehensive quality standard system for Anhui Province’s TCM formula granules, serving as the foundation for the official release of Anhui Provincial TCM Formula Granule Standards. Furthermore, it seeks to facilitate the elevation of provincial standards to national standards, thereby contributing to the continuous improvement of China’s TCM regulatory framework.