蜜丸是传统中药丸剂的主要剂型之一，临床应用已逾2 000年。然而，目前蜜丸的剂型特征与分子机制尚不十分明确，质量控制与评价体系亦不完善，制约了其现代化发展与临床合理应用。系统梳理蜜丸的历史沿革及“丸者缓也”等中医药理论认识；重点阐述蜜丸的剂型特征，主要包括炼蜜的作用、适宜制蜜丸的中药材、蜜丸适宜治疗的疾病，以及蜜丸中成分的释放特征与入血规律；对比分析《中国药典》与古籍记载在蜜丸原料药与炼蜜、理化性质、鉴别与含量测定等方面的质量评价法规差异；并剖析当前炼蜜作用机制不明确、质量评价体系存在的关键问题，展望其潜在发展方向。为推动蜜丸的现代化研究、质量标准优化及临床精准应用提供重要理论支撑，对传承和发展传统中药剂型提供参考与借鉴。

Honeyed pill is one of the main dosage forms of traditional Chinese medicine pills, with a clinical application history of over two thousand years. However, the dosage form characteristics and molecular mechanisms of honeyed pills remain unclear, and the quality control and evaluation system is still imperfect, which restricts their modernization development and clinical rational application. This review systematically summarizes the historical evolution of honeyed pills and the theoretical understanding of traditional Chinese medicine such as “pills act slowly”; Focuses on elucidating the dosage form characteristics of honeyed pills, mainly including the role of refined honey, the suitable Chinese medicinal materials for preparing honeyed pills, the diseases suitable for treatment with honeyed pills, as well as the release characteristics and in vivo absorption patterns of components in honeyed pills; Compares and analyzes the differences in quality evaluation regulations between the Chinese Pharmacopoeia and ancient records regarding the raw materials, refined honey, physicochemical properties, identification, and content determination of honeyed pills; and examines the current problems of unclear mechanism of refined honey and key issues in the quality evaluation system, while prospecting potential development directions. This review provides important theoretical support for promoting the modernization research, quality standard optimization, and clinical precise application of honeyed pills, and providing references and insights for the inheritance and development of traditional Chinese medicine formulations.

R283.6

山西省基础研究计划（自由探索类）青年科学研究项目（202403021222029）