一测多评法测定补心软脉颗粒中红景天苷、马钱苷和虎杖苷含量

摘要

Objective To develop a method of quantitative analysis of multi-components with single marker (QAMS) for simultaneous determination of Salidroside, Loganin and Polydatin;To validate its accuracy and feasibility in Buxin Ruanmai Granules.Methods Salidroside was used as the internal reference substance, and the content of Salidroside in Buxin Ruanmai granules was determined by external standard method, with a purpose to establish its relative correction factor with Loganin and Polydatin. The contents of Loganin and Polydatin were calculated by the relative correction factor, and then multi-components assay with single marker was realized. The three contents in Buxin Ruanmai Granules were determined by both QAMS and external standard method, and their results were also compared.Results The results of 10 batches of samples by two methods did not show significant difference, which showed that relative correction factors had good reproducibility and credits.Conclusion The QAMS method can be used to quality evaluation with multiple indicators of Buxin Ruanmai Granules.%目的：建立同时测定补心软脉颗粒中红景天苷、马钱苷和虎杖苷含量的一测多评分析方法，并验证此方法在该制剂中应用的准确性和可行性。方法以红景天苷为内标物，采用外标法测定补心软脉颗粒中红景天苷的含量，建立其与马钱苷和虎杖苷的相对校正因子，通过该校正因子对马钱苷和虎杖苷进行含量计算，从而实现一测多评。同时采用常规的外标法测定补心软脉颗粒中这3种成分的含量，并将一测多评法的计算值与外标法的实测值进行比较。结果10批补心软脉颗粒一测多评法的计算结果与外标法的实测值之间没有显著差异，表明试验所得的相对校正因子具有很好的重现性和可信度。结论一测多评法可用于补心软脉颗粒多指标质量评价研究。