基于《中國藥典》2015年版與2020年版，系統(tǒng)性分析比較2版《中國藥典》收載的中藥片劑質(zhì)量控制項目的相關(guān)內(nèi)容，詳細梳理性狀、鑒別、檢查項、含量測定、浸出物檢測、特征圖譜與指紋圖譜等中藥片劑的質(zhì)量控制項目的差異。在2015年版的基礎上，2020年版中對多項質(zhì)量控制項目進行了完善和細節(jié)補充，提升了《中國藥典》的科學性、規(guī)范性、權(quán)威性和實用性。同時針對目前《中國藥典》在中藥片劑質(zhì)量控制項目方面的不足，對中藥片劑的未來發(fā)展和質(zhì)量管理提出了具體的思考和建議，為提高中藥片劑的質(zhì)量控制水平提供重要參考，也為新版《中國藥典》中藥片劑的編寫和修訂提供科學依據(jù)。

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.

R286

山西省應用基礎研究青年項目（201901D211525）；山西省中醫(yī)藥研究院院級課題（ZJ-202231）