基于指纹图谱及一测多评法的芍药甘草汤物质基准质量评价研究

Quality evaluation of substance benchmarks of Shaoyao Gancao decoction based on fingerprint and quantitative analysis of multi-components with single markers method

目的建立芍药甘草汤物质基准中8种成分的一测多评法和指纹图谱,并对其质量进行评价。方法采用指纹图谱结合一测多评法,以芍药苷为内标,计算芍药内酯苷、芹糖甘草苷、甘草苷、异甘草苷、甘草素、苯甲酰芍药苷和甘草酸的相对校正因子,测定15批芍药甘草汤物质基准各成分的含量,计算相似度。比较标准曲线法、外标一点法和一测多评法测量结果,验证一测多评法法的可行性和适用性。结果一测多评法的相对校正因子重现性良好,与标准曲线法和外标法的分析结果无显著差异。多批次芍药甘草汤物质基准指纹图谱相似度均在0.90以上。结论该方法准确、可行、高效,可用于芍药甘草汤物质基准质量评价。

Objective To establish the quantitative analysis of multi-components with single-markers(QAMS)method for 8 components and fingerprints of the substance benchmarks of Shaoyao Gancao decoction to evaluate their quality.Methods Based on HPLC fingerprints and QAMS method,paeoniflorin was used as the internal standard,and the relative correction factors of albiflorin,isoliquiritin apioside,liquiritin,isoliquiritin,liquiritigenin,benzoylpaeoniflorin and glycyrrhizic acid were calculated.The content of each component in 15 batches of the substance benchmarks of Shaoyao Gancao decoction and the similarity were determined.The results of standard curve method,external standard one-point method and QAMS method were compared,and the feasibility and accuracy of QAMS method verified.Results The relative correction factors of QAMS method were reproducible.There was no significant difference in the three methods.The similarity of 15 batches of the substance benchmarks of Shaoyao Gancao decoction were greater than 0.90.Conclusion The established QAMS method is accurate,feasible and efficient,which can be used to evaluate the quality of the substance benchmarks of Shaoyao Gancao decoction.