Construction of Multi-Component Quantitative Control and Comprehensive Quality Evaluation Model of Qingnao Jiangya Tablets(清脑降压片)
Objective:To establish a quality evaluation method for Qingnao Jiangya tablets by quantitative analysis of multi-components with a single-marker(QAMS),to determine the contents of 11 components at the same time,and to construct the comprehensive quality evaluation model of OPLS-DA and EM-TOPSIS.Methods:HPLC was used with Agilent Extend C18 column as the chromatographic column and acetonitrile-0.1％formic acid as the mobile phase.The contents of β-ecdy sterone,isorhynchophylline,rhynchophylline,baicalin,wogonosid,rubrofusarin-6-O-beta-D-gentiobioside,cassiaside C,aurantio-obtusin,danshensu,salvianolic acid B and tanshinoneⅡA in 18 batches of Qingnao Jiangya tablets were determined.Principal component analysis(PCA)and orthogonal partial least squares discriminant analysis(OPLS-DA)method were used for comprehensive quality evaluation.Results:The 11 components showed good linear relationships within their respective ranges(r≥ 0.999),and their precision,repeatability,stability and accuracy were good(RSD＜2.0％).Then wogonosid was chosen as internal reference for calculation the correction factors for the other ten components.The average relative correction factors of β-ecdysterone,isorhynchophylline,rhynchophylline,baicalin,rubrofusarin-6-O-beta-D-gentiobioside,cassiaside C,aurantio-obtusin,danshensu,salvianolic acid B and tanshinone ⅡA were respectively 1.648 9,0.925 7,1.434 6,1.299 1,0.751 6,0.8369,1.129 5,1.573 0,0.788 5 and 1.256 9.There was no significant difference between the data analyzed by ESM and the data obtained from QAMS method(P＞0.05).The PCA results showed that there were some differences in the quality of different batches of Qingnao Jiangya tablets.The OPLS-DA showed that baicalin,wogonosid,salvianolic acid B,rubrofusarin-6-O-beta-D-gentiobioside and[3-ecdysterone were the main factors to distinguish Qingnao Jiangya tablets.Conclusion:The established method is of great significance for quality control and overall evaluation of Qingnao Jiangya tablets..
万方数据
维普
