[关键词]
[摘要]
乌梅Mume Fructus(蔷薇科植物梅Prunus mume的干燥近成熟果实)为药食同源常用中药。《中国药典》以枸橼酸为单一含量指标,难以全面反映其酸涩收敛药性、炮制转化、肠道局部效应和安全边界。基于中药质量标志物(quality marker,Q-Marker)理论,沿传统药性、炮制加工、肠道作用、安全控制和质量传递证据链,系统梳理乌梅化学成分、药理效应、炮制变化及安全风险研究进展。在Q-Marker特有性、有效性、可测性、传递与溯源原则下,将枸橼酸、苹果酸、奎尼酸、琥珀酸、5-羟甲基糠醛(5-hydroxymethylfurfural,5-HMF)、mumefural和苦杏仁苷列为现阶段证据较充分且可用于标准转化的核心Q-Marker。3-O-/4-O-/5-O-咖啡酰奎宁酸、咖啡酸、原儿茶酸、对香豆酸等成分可作为功效关联候选。总多酚(鞣质)含量可作为涩味质量属性的辅助表征参数。黄酮、三萜和多糖目前更适合作为待验证成分群,不宜直接等同于可量化核心Q-Marker。5-HMF、糠醛和mumefural可作为炮制过程化学标志物。色度、水分和浸出物属于过程质量表征指标,应与化学标志物分层使用。苦杏仁苷、5-HMF上限、重金属及二氧化硫残留应纳入安全控制。提出一核心、四类指标、多环节验证的质量评价思路,为乌梅药材、饮片、炮制品及相关制剂的质量控制和标准升级提供参考。
[Key word]
[Abstract]
Wumei (Mume Fructus, the dried near-ripe fruit of Prunus mume) is a commonly used medicinal and edible traditional Chinese medicine. The Chinese Pharmacopoeia currently uses citric acid as the sole quantitative marker, which cannot fully represent its sour-astringent and converging properties, processing-related transformation, intestinal local effects, and safety boundaries. Guided by quality marker (Q-Marker) theory, this review evaluates chemical constituents, pharmacological effects, processing changes, and safety risks of Mume Fructus through the evidence chain of traditional properties, processing, intestinal action, safety control, and quality transmission. According to the core principles of specificity, effectiveness, measurability, transfer, and traceability, citric acid, malic acid, quinic acid, succinic acid, 5-HMF, mumefural, and amygdalin are proposed as current core Q-Markers with relatively sufficient evidence and standard-conversion value. Defined phenolic acids including 3-O-, 4-O-, and 5-O-caffeoylquinic acids, caffeic acid, protocatechuic acid, and p-coumaric acid are retained as efficacy-associated candidates, while total polyphenol (tannin) content serves as an auxiliary characterization parameter for astringent quality attributes. Flavonoids, triterpenoids, and polysaccharides are treated as component groups requiring further verification rather than directly as quantitative core Q-Markers. 5-HMF, furfural, and mumefural may serve as chemical processing markers, whereas colorimetric parameters, moisture, and extractive values are process-quality descriptors that should be stratified from chemical markers. Amygdalin, the upper limit of 5-HMF, heavy metals, and sulfur dioxide residues are used as safety control indicators. This review proposes a quality evaluation strategy based on one core, four indicator layers, and multi-stage verification for quality control and standard upgrading of Mume Fructus crude drugs, decoction pieces, processed products, and related preparations.
[中图分类号]
R284
[基金项目]
省部共建中医湿证国家重点实验室贵阳(GZSYSGYGZZ-2023008);国家中医药管理局高水平中医药重点学科建设项(zyyzdxk-2023187);贵州省高等学校中西医结合防治疾病转化医学重点实验室(黔教技[2023]017号);贵州中医药大学中西医结合防治消化系统疾病科技创新人才团队建设项目(贵中医TD合字[2023]001号)