Quality evaluation of Warming Jingjintong Paste based on HPLC fingerprint and stoichiometry
Objective:To establish the HPLC fingerprint of Warming Jingjintong Paste and its 7 components content determination method with stoichiometric method,so as to provide scientific basis for its quality evaluation.Methods:The fingerprint of 12 batches of Warming Jingjintong Paste were determined by high performance liquid chromatography(HPLC)and the common peak was determined and the similarity was evaluated.The components of berberine hydrochloride,psoralen,isopsoralen,paeonol,calycosin-7-O-β-D-glucoside,formononetin and emodin were determined by reference,and the contents of these components were determined.With the help of SPSS 16.0,SIMCA-P 14.1 and other software,cluster analysis,principal component analysis,least squares discriminant analysis(OPLS-DA)and other stoichiometric analysis were performed on 12 batches of Warming Jingjintong Paste.Results:A total of 32 common peaks were identified by 12 batches of Warming Jingjintong Paste fingerprint,and the similarity was greater than 0.9.At the same time,7 component peaks were identified,and the linear relationship of the 7 components was relatively good(R2 ≥ 0.9990).RSDs of repeatability,precision and stability were all less than 5%,and RSDs of recovery tests were all less than 5%when reference substances were added to 100%of known contents.The contents of 7 components in 12 batches of Warming Jingjintong Paste were 17.69~52.48,24.07~50.86,22.73~58.39,74.76~130.30,7.71~10.25,1.07~5.10,16.18~46.89 pg/g,respectively.Stoichiometric analysis showed that S5 could be divided into class Ⅰ and other batches into class Ⅱ.A total of 15 difference markers were identified by OPLS-DA.Conclusion:The fingerprint and content determination methods established in this study are scientific,reliable and combined with stoichiometry,which lays a foundation for the quality control of Warming Jingjintong Paste and the research of late dosage form.