经典名方旋覆代赭汤物质基准的质量研究

Study on the Quality of Substance Benchmark of Famous Prescription of Xuanfu Daizhe Decoction

目的:建立15批旋覆代赭汤物质基准的特征图谱和含量测定方法。方法:通过HPLC法测定15批旋覆代赭汤物质基准特征图谱和人参皂苷Rg1、人参皂苷Re、甘草苷、甘草酸、6-姜辣素、芦丁的含量,采用“中药色谱指纹图谱相似度评价系统(2012版)”和SPSS 21.0软件对特征图谱进行评价。结果:15批旋覆代赭汤样品共标记了17个共有峰,指认了7个成分,相似度为0.882~0.998。聚类分析可将15批样品聚为3类。上述6个成分的平均加样回收率分别为96.46%、98.93%、97.26%、102.83%、97.91%、101.57%。以含量均值上下浮动30%规定含量范围未出现离散数据。结论:建立的特征图谱和含量测定方法简便、稳定、准确,可为旋覆代赭汤物质基准的质量研究提供参考。

Objective:To establish a characteristic fingerprint and content determination methods of substance benchmark of 15 batches of Xuanfu daizhe decoction.Methods:HPLC was used to determine the substance reference characteristic fingerprint and the contents of ginsenoside Rg1,ginsenoside Re,glycyrrhizin,glycyrrhizic acid,6-gingerol,rutin in 15 batches of Xuanfu daizhe decoction.The“Similarity Evaluation System of TCM Chromatographic Fingerprint(2012 edition)”and SPSS 21.0 software were used to evaluate the characteristic fingerprint.Results:A total of 17 common peaks were screened in the 15 batches of samples and seven components were identified.The similarity was between 0.882 to 0.998.Cluster analysis could be used to cluster 15 batches of samples into 3 groups.The average recovery rates of above six components were 96.46%,98.93%,97.26%,102.83%,97.91%,101.57%,respectively.There was no discrete data in the content range defined by 30%fluctuation of content mean.Conclusion:The characteristic fingerprint and content determination methods are simple,stable and accurate.It can provide reference for quality research of Xuanfu daizhe decoction substance benchmark.