中药药理与临床2026，Vol.42Issue(2)：58-67,10.
降防保心胶囊入血成分和质量评价研究
Study on Plasma Components and Quality Evaluation of Jiangfang Baoxin Capsules
摘要
Abstract
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.关键词
降防保心胶囊/超高效液相色谱-电喷雾-四极杆-飞行时间-串联质谱技术/入血成分/指纹图谱/质量控制Key words
Jiangfang Baoxin Capsules/UPLC-QTOF-MS/Plasma component/Fingerprint/Quality control引用本文复制引用
施之琪,陆曙..降防保心胶囊入血成分和质量评价研究[J].中药药理与临床,2026,42(2):58-67,10.基金项目
国家自然科学基金项目(编号:82274427) （编号:82274427）
江苏省中医药管理局国家中医临床研究基地开放课题资助项目(编号:SD2023SZ20) （编号:SD2023SZ20）
南京中医药大学自然科学基金项目(编号:XZR2023092) （编号:XZR2023092）
无锡市卫健委双百拔尖人才项目(编号:HB2023076) （编号:HB2023076）
无锡市"太湖人才计划"高端医学团队项目(编号:锡人才办[p2021]9号). （编号:锡人才办[p2021]9号）
