[关键词]
[摘要]
淫羊藿Epimedii Folium为补肾壮阳、强筋健骨、祛风除湿常用中药,在骨质疏松、生殖功能调节、炎症免疫及神经保护等方面具有较明确的药效基础。现代研究表明,淫羊藿中主要含有黄酮类、多糖类、生物碱类、有机酸类及木脂素类等成分,其中异戊烯基黄酮类成分是其发挥主要药效和现行质量评价的核心成分群,多糖、酚酸、生物碱等非黄酮成分则可提供免疫调节、抗氧化、基原/部位差异及过程控制等补充质量信息。当前淫羊藿质量控制仍偏重少数黄酮类指标,难以全面反映基原差异、药用部位、产地生态、采收期、炮制转化、体内暴露及药效安全性的整体关联。基于“基原-部位-产地-采收-炮制-入血/肠道转化-药效和安全性”连续证据链,将全成分群解析定位为质量标志物(quality marker,Q-Marker)筛选的证据池,并依据Q-Marker的五原则对候选成分进行分层。综合现有证据,朝藿定A~C、淫羊藿苷、宝藿苷I、淫羊藿素及淫羊藿次苷II可作为当前证据最充分的核心候选Q-Marker;多糖、酚酸和木兰花碱等可作为扩展或场景化评价指标。进一步提出“统一核心指标+基原特异性参考区间+过程传递校正+安全风险约束”的多维度质量评价策略,为淫羊藿质量标准完善和产品质量一致性评价提供参考。
[Key word]
[Abstract]
Yingyanghuo (Epimedii Folium) is a commonly used traditional Chinese medicine for tonifying kidney yang, strengthening tendons and bones, and dispelling wind-dampness. Modern studies have shown that Epimedii Folium contains flavonoids, polysaccharides, alkaloids, organic acids, lignans and other constituents. Among them, prenylated flavonoids remain the core component group for pharmacological effects and routine quality control, whereas non-flavonoid constituents provide complementary information related to immunomodulation, antioxidation, botanical origin, medicinal part and processing-related quality variation. Current quality control still focuses mainly on several flavonoid markers and is insufficient to reflect the continuous association among botanical origin, production area, harvesting, processing, in vivo exposure, efficacy and safety. Based on the evidence chain of “origin-part-production area-harvesting-processing-blood-entering or intestinal transformation-efficacy and safety”, this review regards whole-component group profiling as an evidence pool for quality marker (Q-Marker) discovery and stratifies candidate markers according to specificity, transferability, measurability, effectiveness and safety. Epimedin A—C, icariin, baohuoside I, icaritin and icariside II are proposed as core candidate Q-Markers with the strongest current evidence, whereas polysaccharides, phenolic acids and magnoflorine may serve as extended or scenario-specific quality indicators. A multidimensional strategy integrating unified core markers, origin-specific reference ranges, processing-transfer correction and safety-risk constraints is proposed for improving quality evaluation of Epimedii Folium.
[中图分类号]
R283
[基金项目]
国家自然科学基金区域创新发展联合基金项目(U20A20407);辽宁省中医药创新团队项目(LNZYYCXTD-CCCX-002);辽宁省揭榜挂帅项目(2023JH1/11500004)