基于HPLC指纹图谱及一测多评法的心通颗粒质量评价

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中图分类号R917 文献标志码A 文章编号 1001-0408（2025）15-1866-05

DOI 10.6039/j.issn.1001-0408.2025.15.08

Qualityevaluation of Xintong granules basedon HPLC fingerprint and quantitative analysis of multi components by single-marker method

YE Xide'，FENG Xiaolong1，SHAO Mingguo1，2，WAN Linchun³，HU Zhenyu’，CHEN Chunyu'，WU Yu1 ，BU Junwen'，QIAN Yuhang'，MENG Fanqiang²（1. School of Pharmacy，Jiangxi University of Chinese Medicine， Nanchang 33004， China;2.Lunan Pharmaceutical Group Co.，Ltd.，Shandong Linyi 276006，China;3.Jiangxi InstituteforDrugControl，Nanchang330029，China）

ABSTRACTOBJECTIVEToestablishthe HPLCfingerprintof Xintonggranulesand thequantitativeanalysisof multicomponents bysingle-marker method（QAMS）todetermine thecontentsof7components，soastoprovideascientific basis for theirqualitycontrol.METHODS HPLCmethodwasusedtoestablish thefingerprints for10batchesof Xintonggranules（No.S1- S10），and similarityevaluation，cluster analysis（CA）and partial leastsquares-discriminant analysis （PLS-DA）wereperformed. At the same time，the contents of seven components，including puerarin，daidzin，calycosin-7-O- β -D-glucoside， stilbene glycoside，naringin，icarinandtanshinoneIA，were determinedbyQAMSmethod，and werecomparedwiththeresultsof externalstandardmethod.RESULTSAtotalof18commonpeaksweremarkedand7peakswereidentifiedintheHPLC fingerprints for 10 batches of Xintong granules，namely puerarin （peak 4），daidzin （peak 7），calycosin-7-O. ⋅β -D-glucoside（peak 9），stilbene glycoside（peak1O），naringin（peak12），icarin（peak17），andtanshinoneIA（peakl8）；the similaritisamong themwere morethanO.990，andCAandPLS-DAresultsshowedthatS4-S5，S8-S10，S1-S3andS6-S7wereclusteredintothree categories，respectively.Using naringinastheinternal standard，thecontentsof puerarin，daidzin，calycosin-7-O ⋅β -D-glucoside， stibeneglyoside，icarinandtanshnoneIAweredeterminedtobe7.8681-10.1812，.709.741，0.2852-03263，24- 1.5239，0.140 2-0.290 4，and 0.077 1-0.219 4mg/g ，respectively，by the QAMS. These results showed no significant differences compared to thoseobtained bythe exteral standard method.CONCLUSIONS Established HPLCfingerprint andQAMS method

areconvenient，stableandaccurate，whichcanprovideabasis forthe quality evaluation of Xintong granules.

KEYWORDS Xintong granules； fingerprint； quantitativeanalysisofmulti-componentsbysingle-markermethod;content determination

冠状动脉粥样硬化性心脏病，简称冠心病，是一种缺血性心脏病。（剩余7942字）