A Quality Evaluation System Based On HPLC/DAD(ELSD)/MS Fingerprint For Shutangluo Granules

As is known,the therapeutic effect of the traditional Chinese medicine depends on a premium quality.The entire quality control of the traditional Chinese medicine has always been a difficult problem because of the complicated and multiple components.Thus it is important to control the holistic quality of the traditional Chinese medicine.Shutangluo granule is derived from a clinical experience prescription of the Hospital of Integrated Traditional Chinese and Western Medicine,which consists of Euonymus alatus,Coptidis rhizoma,Puerariae radix,Rehmanniae radix,Campsis flos.This study is to found a holistic quality evaluation system by establishing the fingerprint of crud herbs,crud herbs after extraction process,intermediate and the final granule,which could guarantee the quality of the whole production process and the therapeutic effect.The HPLC-DAD fingerprint of crud herbs,crud herbs after extraction process,intermediate and the final granule were achieved to find the characteristic peaks,caculate the similarity and evaluate the quality of them.After comparison the HPLC-DAD spectrum of crud herbs,crud herbs after extraction process,intermediate and the final granule,the attribution of the components in the crud herbs was achieved.The HPLC-D AD-MS chromatography of crud herbs,crud herbs after extraction process,intermediate and the final granule were achieved.Then,the mass and the UV data were compared and the characteristic peaks were indentified to further study the the attribution of the components in the crud herbs.Results:There were 11 characteristic peaks in Puerariae radix and Puerariae radix after extraction process,and 15 in intermediate and the granule.The similarities of all the analytes between batch-to-batch were over 0.9,which showed the quality of the Puerariae radix,Puerariae radix after extraction process,intermediate and the granule were all stable and homogeneous.There were 11 characteristic peaks in Puerariae radix after extraction process,intermediate and the granule could be attributed to the Puerariae radix.And the characteristic peaks which could be finally remained were probably puerarin-4’-O-glucoside or daidzein-7,4’-diglucoside,3’-hydroxy puerarin,3’-hydroxy mirificin,puerarin,3’-methoxy puerarin,mirificin or 7-xylose,puerarin,daidzin,pueroside D,ononin and daidzein.The 3 characteristic peaks that intermediate and the granule shared were gallic acid,5-(α-D-glucopyranosyloxymethyl)-2-furancarboxaldehyde,acteoside,jatrorrhizine and columbamine.There were 7 characteristic peaks in Coptidis rhizoma and Coptidis rhizoma after extraction process,intermediate and the granule.The similarities of all the analytes between batch-to-batch were over 0.9,which showed the quality of the Coptidis rhizoma,Coptidis rhizoma after extraction process,intermediate and the granule were all stable and homogeneous.There were total 7 characteristic peaks in the Coptidis rhizoma after extraction process,intermediate and the granule could be attributed.And the characteristic peaks remained were magnoflorine,thalifendine/berberastin jatrorrhizine/columbamine,epiberberine,coptisine,palmatine and berberine.The 3 characteristic peaks that intermediate and the granule shared were puerarin,daidzin,and daidzein.There were 14 characteristic peaks in Rehmanniae radix and Rehmanniae radix after extraction process,and 13 in the intermediate and the granule.The similarities of all the analytes between batch-to-batch were over 0.9,which showed the quality of the Rehmanniae radix,Rehmanniae radix after extraction process,intermediate and the granule were all stable and homogeneous.There were 14 characteristic peaks in Rehmanniae radix after extraction process could be attributed,and there were total 3 characteristic peaks in the intermediate and the granule could be attributed.And the characteristic peaks remained were 5-hydroxymethylfurfural,acteoside and is-acteoside.The 10 characteristic peaks that intermediate and the granule shared were gallic acid,3’-hydroxy puerarin,puerarin,3’-methoxy puerarin,mirificin or 7-xylose puerarin,mirificin or 7-xylose puerarin,daidzin,pueroside D,ononin and daidzein.The characteristic peaks in Campsis flos and Campsis flos after extraction process,intermediate and the granule were 7,5,9 and 9.The similarities of all the analytes between batch-to-batch were over 0.9,which showed the quality of the Campsis flos,Campsis flos after extraction process,intermediate and the granule wereall stable and homogeneous.There were total 2 characteristic peaks in Campsis flos after extraction process,the intermediate and the granule could be attributed.And the characteristic peaks remained were acteoside and is-acteoside.The 7 characteristic peaks that intermediate and the granule shared were gallic acid,puerarin,3’-methoxy puerarin,daidzin,pueroside D,ononin and daidzein.There were 14 characteristic peaks in Euonymus alatus and 9 in Euonymus alatus after extraction process.The similarities of all the analytes between batch-to-batch were over 0.9,which showed the quality of the Euonymus alatus,Euonymus alatus after extraction process were all stable and homogeneous.Because the poor response of the Euonymus alatus could result to the serious disturbance from the other herbs.So,the quality of the intermediate and the granule were not studied.There were all 6 characteristic peaks in Euonymus alatus after extraction process could be attributed,and there were all 2 characteristic peaks in intermediate and the granule could be attributed.And the 2 characteristic peaks remained were gallic acid and a kind of dicatechin.The 11 characteristic peaks that intermediate and the granule shared were puerarin,3’-methoxy puerarin mirificin or 7-xylose puerarin,daidzin,genistin,genistein-7-O-β-D-apiofuranosyl-(1→6)7-O-β-D-glucopyranoside,acteoside,isomer of acteoside,daidzein and berberine.