Establishment of Quality Evaluation Method for Wendan Decoction Granules
Objective To establish a method for evaluating the quality of Wendan Decoction Granules.Methods The high-performance liquid chromatography(HPLC)fingerprints for fifteen batches of Wendan Decoction Granules were established,and similarity analysis and identification and attribution of common peaks were performed.Hierarchical cluster analysis(HCA),principal component analysis(PC A),and orthogonal partial least squares-discriminant analysis(OPLS-DA)were used to evaluate the quality of 15 batches of Wendan Decoction Granules.HPLC method used for the content determination of guanosine,uridine,hesperidin,and 6-gingerol was established.Results The fingerprint similarity of fifteen batches of Wendan Decoction Granules was higher than 0.950,with thirty-three common peaks attributed and eight chromatographic peaks identified,namely peak 16(liquiritin),peak 19(naringin),peak 20(hesperidin),peak 21(neohesperidin),peak 28(glycyrrhizic acid),peak 29(tangerine),peak 30(6-gingerol),and peak 32(hesperidin).The samples were divided into five categories by HCA analysis.Seven principal components were screened through PCA,with a cumulative variance contribution rate of 93.131％.The results of OPLS-DA and HCA were consistent,and fourteen differential components were screened.The content determination results by HPLC showed that guanosine,uridine,hesperidin,and 6-gingerol had good linear relationships with peak area integration values within their respective mass concentration ranges(R2 ≥ 0.999 1).The RSDs of precision,stability,and repeatability test results were all lower than 2.5％(n=6).The average recoveries of guanosine,uridine,hesperidin,and 6-gingerol were 99.27％,99.35％,98.51％,and 99.58％,with RSDs of 0.85％,1.52％,1.39％,and 1.04％(n=6),respectively.The average contents of guanosine,uridine,hesperidin,and 6-gingerol in fifteen batches of Wendan Decoction Granules were 0.017 6％,0.016 9％,1.046 7％,and 0.022 2％,respectively.Conclusion The established method is simple,rapiid,highly specific and has good reproducibility,which can reflect information on various chemical components,which can provide a reference for the quality control of Wendan Decoction Granules.
万方数据
维普
