[关键词]
[摘要]
目的 应用建立的“有效性-可测性-特异性”三维整合策略,系统筛选生血宝合剂的潜在质量标志物(quality marker,Q-Marker),为完善其质量控制体系提供依据。方法 以有效性、可测性、特异性为核心维度,采用层次分析法(analytic hierarchy process,AHP)确定各维度权重。有效性维度通过文献调研结合网络药理学分析进行赋值,可测性维度基于HPLC和UPLC-Q-TOF-MS/MS检测可行性进行评价,特异性维度通过化合物药材归属溯源分析进行判定。计算各候选成分三维评分及综合得分,以雷达图回归面积作为Q-Marker筛选的量化依据。结果 基于三维整合策略综合评价,筛选出芍药苷、特女贞苷、红景天苷、绿原酸、芍药内酯苷、2,3,5,4′-四羟基二苯乙烯-2-O-β-D-葡萄糖苷共6种综合评分领先、兼具明确药效关联性、良好色谱检测性与处方来源特异性的成分,作为生血宝合剂的潜在Q-Marker。结论 所应用的“有效性-可测性-特异性”三维整合策略准确可靠,确定了生血宝合剂中的6种潜在Q-Marker,为生血宝合剂质量标准的完善与提升提供了关键技术支撑,同时也为中药复方Q-Marker的定量识别与质量控制体系构建提供了方法学参考。
[Key word]
[Abstract]
Objective By applying the previously established “effectiveness-measurability-specificity” three-dimensional integrated strategy, the potential quality markers (Q-Markers) of the Shengxuebao Mixture (SM, 生血宝合剂) were systematically screened, providing a basis for improving its quality control system. Methods With effectiveness, measurability and specificity as the core dimensions, the analytic hierarchy process (AHP) was employed to determine the weights of each dimension. The effectiveness dimension was assigned values through literature research combined with network pharmacology analysis, the measurability dimension was evaluated based on the feasibility of HPLC and UPLC-Q-TOF-MS/MS detection, and the specificity dimension was determined through the traceability analysis of compound medicinal materials. The three-dimensional scores and comprehensive scores of each candidate component were calculated, and the regression area of the radar chart was used as the quantitative basis for Q-Marker screening. Results Based on the comprehensive evaluation of the above three-dimensional integration strategy, six components with the highest overall scores, which have clear pharmacological efficacy correlations, good chromatographic detection properties, and specific prescription sources, namely paeoniflorin, specnuezhenide, salidroside, chlorogenic acid, albiflorin, and 2,3,5,4′-tetrahydroxystilbene-2-O-β-D-glucoside, were finally selected as potential Q-Markers for the SM. Conclusion The three-dimensional integrated strategy of “effectiveness-measurability-specificity” applied was accurate and reliable. It identified six potential Q-Markers in the SM, providing key technical support for the improvement and enhancement of the quality standards of the SM. At the same time, it also offered methodological references for the quantitative identification and quality control system construction of traditional Chinese medicine compound Q-Markers.
[中图分类号]
R283.6
[基金项目]
陕西省重点研发计划项目(2024SF-ZDCYL-03-16);陕西省三秦英才特殊支持计划创新创业团队项目(2023)