经典名方旋覆代赭汤物质基准特征图谱及指标成分含量测定研究

Characteristic chromatogram and index components content of substance benchmark of Xuanfu Daizhe Decoction

该研究以不同批次饮片及同批次饮片投料制备18批旋覆代赭汤物质基准对应实物,建立HPLC特征图谱,采用《中药色谱指纹图谱相似度评价》软件进行相似度分析;以甘草苷、甘草酸、6-姜辣素、人参皂苷Rg_(1)、人参皂苷Re为指标性成分建立旋覆代赭汤中多成分高效液相色谱含量测定方法,以不超过质量均值的70%~130%为界限设定各质控指标的量值波动范围。研究结果表明,18批旋覆代赭汤对应实物的特征图谱共有19个特征峰,指认出甘草苷、1,5-O-二咖啡酰奎宁酸、人参皂苷Rg_(1)、人参皂苷Re、1-O-乙酰旋覆花内酯、人参皂苷Rb_(1)、甘草酸、6-姜辣素8个色谱峰,相似度均大于0.97;对应实物中甘草苷质量分数0.53%~0.86%,甘草酸质量分数0.61%~1.2%,6-姜辣素质量分数0.023%~0.068%,人参皂苷Rg_(1)和人参皂苷Re总量0.33%~0.66%,除个别批次外,多数对应实物中各指标性成分含量稳定无离散。该研究通过特征图谱、含量测定表征了旋覆代赭汤中旋覆花、人参、生姜、甘草4味药信息,为旋覆代赭汤物质基准及制剂关键化学属性的质量评价奠定了基础。

The methods for determining the characteristic chromatogram and index components content of Xuanfu Daizhe Decoction were established to provide a scientific basis for the quality evaluation of substance benchmarks and preparations.Eighteen batches of Xuanfu Daizhe Decoction were prepared with the decoction pieces of different batches and of the same batch were prepared respectively,and the HPLC characteristic chromatograms of these samples were established.The similarities of the chromatographic fingerprints were analyzed.With liquiritin,glycyrrhizic acid,6-gingerol,ginsenoside Rg_(1),and ginsenoside Re as index components,the high performance liquid chromatography was established for content determination with no more than 70%-130%of the mass average as the limit.The results showed that there were 19 characteristic peaks corresponding to the characteristic chromatograms of 18 batches of Xuanfu Daizhe Decoction,including 8 peaks representing liquiritin,1,5-O-dicaffeoylqunic acid,ginsenoside Rg_(1),ginsenoside Re,1-O-acetyl britannilactone,ginsenoside Rb_(1),glycyrrhizic acid,and 6-gingerol,and the fingerprint similarity was greater than 0.97.The contents of liquiritin,glycyrrhizic acid,6-gingerol,and ginsenosides Rg_(1)+Re in the prepared Xuanfu Daizhe Decoction samples were 0.53%-0.86%,0.61%-1.2%,0.023%-0.068%,and 0.33%-0.66%,respectively.Except for several batches,most batches of Xuanfu Daizhe Decoction showed stable contents of index components,with no discrete values.The characteristic chromatograms and index components content characterized the information of Inulae Flos,Ginseng Radix et Rhizoma,Glycyrrhizae Radix et Rhizoma,and Zingiberis Rhizoma Recens in Xuanfu Daizhe Decoction.This study provides a scientific basis for the further research on the key chemical properties of substance benchmark and preparations of Xuanfu Daizhe Decoction.