Establishment of Compound Kushen Mixture HPLC fingerprint map and study on quality control
Objective To establish the HPLC fingerprint of compound matrine,oxymatrine,gallic acid,liquiritin and glycyrrhizic acid,and provide experimental basis for quality control.Methods Green ODS-AQ C18(4.6 mm× 250 mm,5 μm)column,gradient elution with acetonitrile-0.5％phosphate acid solution.The flow rate at 1mL/min,and the detection wavelength was 235 nm.The fingerprints of 10 batches of preparations were established.The Traditional Chinese Medicine Chromatographic Fingerprint Similarity Evaluation System was used to evaluate the similarity of the fingerprint of 10 batches of preparations.The main chemical components of the main characteristic peaks in the preparations were determined by comparing the retention time of each peak in the control substance and the sample,and the attribution of each flavor component in the preparations was preliminarily determined by analysis.Principal component analysis(PCA)and orthogonal partial least squares discriminant analysis(OPLS-DA)were used to identify the determination results,and the content of matrine,oxymatrine,gallic acid,liquiritin and glycyrrhizic acid in the preparation was determined.Results The precision,repeatability and stability of the compound HPLC fingerprint map were investigated,and the results were good.The similarity of the 10 approved formula was 0.822～0.983,31 common peaks were identified,and 5 main characteristic peaks,including matrine,oxymatrine,gallic acid,liquiritin and glycyrrhizic acid were identified.The 10 batches of Compound Kushen Mixture preparations could be divided into 3 categories by PCA,and the quality differences between different regions and different batches could be seen,and the difference components were further screened by OPLS-DA.Conclusion The established fingerprint method of Compound Kushen Mixture is stable and reliable,compared with the content determination method in the existing quality standard,it can be used as a reference index in the quality control of compound bitter ginseng agent,providing an experimental basis for the quality control of Compound Kushen Mixture and clinical medication research.
Compound Kushen MixtureHPLCFinger printQuality control
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