中国中药杂志2025，Vol.50Issue(21)：5987-5998,12.DOI:10.19540/j.cnki.cjcmm.20250430.301
大蜜丸炼蜜单元5-HMF的中药制造测量技术进展
Advances in manufacturing measurement technology for 5-HMF formed during honey-refining process for large traditional Chinese medicine honeyed pills
摘要
Abstract
Large traditional Chinese medicine(TCM)honeyed pills are widely recognized for their stable therapeutic efficacy and convenient administration,occupying a prominent position among classical TCM dosage forms.However,the honey-refining process not only directly affects the efficacy and stability of these formulations but also serves as the primary source of 5-hydroxymethylfurfural(5-HMF),a potentially toxic compound.In light of its toxicological risks and the residue limits specified in the Pharmacopoeia of the People's Republic of China(2020 edition),achieving real-time and precise control of 5-HMF content has emerged as a key challenge in TCM manufacturing measurement.This review,based on research in TCM manufacturing measurement,outlined the toxicological controversies,quality control challenges,formation mechanisms,and influencing factors associated with 5-HMF during the production of large honeyed pills,with the aim of advancing the standardization and intelligent manufacturing of large honeyed pills.First,it examined the toxicological debates and safety thresholds of 5-HMF,identifying several issues during the manufacturing,including unclear residue limits for large honeyed pills,excessive reliance on empirical control during processing,significant risks from cumulative 5-HMF,and insufficient real-time measurement capabilities.Then,it clarified the dominant roles of the Maillard and caramelization reactions in 5-HMF formation and explored how honey composition,refining parameters,and equipment types influence its generation.Subsequently,recent advances in chromatographic,spectroscopic,electrochemical,and biosensor-based detection methods were reviewed,and their applicability to real-time measurement and intelligent control in manufacturing was evaluated.Finally,an intelligent manufacturing system based on a"point-line-plane"quality control framework was proposed for 5-HMF formed during the honey-refining process,emphasizing a future shift toward digitalization,intelligence,and continuous production to comprehensively enhance the safety,standardization,and global competitiveness of large honeyed pill manufacturing.关键词
中药大蜜丸/炼蜜/5-羟甲基糠醛/质量控制/智能制造Key words
large traditional Chinese medicine honeyed pills/honey refining/5-hydroxymethylfurfural/quality control/intelligent manufacturing引用本文复制引用
龙佳,李楠,田晋茹,李明爽,李嘉鑫,杨明月,刘东红,吴志生..大蜜丸炼蜜单元5-HMF的中药制造测量技术进展[J].中国中药杂志,2025,50(21):5987-5998,12.基金项目
国家重点研发计划项目(2023YFC3504505) （2023YFC3504505）
中华中医药学会立项项目(CACM-2023-QNRC2-B10) （CACM-2023-QNRC2-B10）
国家自然科学基金项目(82274110,82404857) （82274110,82404857）
揭榜挂帅项目(2022-JYB-JBZR-018) （2022-JYB-JBZR-018）
江西省重大科技研发专项(20203ABC28W018) （20203ABC28W018）
