Analysis of trends in quality control measures for traditional Chinese medicine tablets based on Chinese Pharmacopoeia
This study conducts a comprehensive analysis and comparison of the quality control parameters for traditional Chinese medicine(TCM)tablets as stipulated in the 2015 and 2020 editions of Chinese Pharmacopoeia.It meticulously documents various quality control measures,including physical characterizations,identification tests,inspection protocols,content determination,extract testing,and both characteristic and fingerprint spectral analyses.Building on the framework established by the 2015 edition,the 2020 revision has introduced refinements and additions to numerous quality control metrics,thereby enhancing the scientific rigor,standardization,authoritative nature,and usability of Chinese Pharmacopoeia.At the same time,specific thoughts and suggestions have been put forward for the future development and quality management of traditional Chinese medicine tablets in response to the shortcomings of the current Chinese Pharmacopoeia in the quality control project of traditional Chinese medicine tablets,Moreover,these improvements provide an essential reference for advancing the quality control practices of TCM tablets and offer a solid scientific foundation for the ongoing development and revision of the TCM tablets section in future editions of Chinese Pharmacopoeia.
Chinese Pharmacopoeiatraditional Chinese medicine tabletsquality controlquality standardsquality management