降防保心胶囊入血成分和质量评价研究OA

Objective:To analyze the plasma components of Jiangfang Baoxin(降防保心)Capsules(JFBX)by the ultra-high performance liquid chromatography-quadrupole time of flight tandem-mass spectrometry(UPLC-QTOF-MS),and to establish the fingerprint and content determination of JFBX.Methods:The plasma components of JFBX were investigated by UPLC-QTOF-MS.The fingerprint of JFBX was established by HPLC.Additionally,the fingerprint was evaluated by the Similarity Evaluation System of TCM Chromatographic Fingerprint(2012 edition)combined with cluster analysis(CA),principal component analysis(PCA),and partial least square discriminant analysis(PLS-DA).The chromatographic peaks were identified by combining the fingerprints of the reference substance.According to the chromatographic conditions established by fingerprint,an analytical method was established for the simultaneous determi-nation of index components.Results:A total of 87 plasma components were obtained by UPLC-QTOF-MS,mainly inclu-ding alkaloids,organic acids,flavonoids,terpenoids,volatile oils,and so on.The fingerprint of JFBX was established by HPLC,and the similarity was shown to be greater than 0.97.Additionally,9 common peaks were identified by reference substance,including gallic acid,chlorogenic acid,puerarin,paeoniflorin,tetrandrine,fangchinoline,senkyunolide I,ferulic acid,and benzoyl paeoniflorin.Based on PCA and PLS-DA,8 batches of samples were closely distributed,the other 2 batches of samples were outside the default core area,with paeonidin,ferulic acid,and chlorogenic acid being screened as difference markers of JFBX.After methodological investigation,a method was established for the simultaneous determina-tion of paeoniflorin,ferulic acid,tetrandrine,fangchinoline,puerarin,benzoyl paeoniflorin,and gallic acid.Conclusion:The plasma composition of JFBX is obtained by preliminary analysis.Then,the fingerprint and content determination method of JFBX are developed according to the analysis results.The established method is accurate and reliable and can be used for the JFBX quality control.