Study On Quality Markers And Quality Evaluation Of Guanxinjing Capsules

Objective:To initially determine the quality marker of Guanxinjing Capsule,and to establish a quality evaluation method based on quality markers.Methods:UHPLC-QTOF-MS/MS component identification,Plant metabolomics and network pharmacology were used to study the quality markers of Guanxinjing Capsule:Guanxinjing Capsule was gradient eluted with a column of Phenomenex C₁₈ Luna?2.0×150mm×3?m,100A?and 0.1%aqueous acetic acid-0.1%acetic acid acetonitrile mobile phase,electrospray ion Source,positive and negative ion mode detection,compounds were identified based on mass spectrometry information;The plant metabonomics method based on Progenesis QI,SPSS and SIMCA-p software was used to find different batches of different compounds in Guanxinjing Capsules;ADME/T calculation method and response intensity were used to screen the active components of Guanxinjing Capsule;Then the active components targets and diseases targets were found using PubChem,Swiss Target Prediction servers and OMIM,TTD,GAD,PharmGkb databases,respectively.The chemical components were correlated with the curative effect to determine the effective substances by target correlation;Quality markers in Guanxinjing Capsules were initially determined by comprehensive consideration of pharmacodynamic indexes,inter-batch changes of samples,compatibility of prescriptions and measurability;The quality markers were quantitatively determined by HPLC-QTRAP-MS/MS positive and negative ion switching monitoring mode,and the quality of different batches of Guanxinjing Capsules was evaluated.Results:A total of 148 compounds in Guanxinjing Capsules,including acids and their derivatives,diterpenoids,monoterpenes and their glycosides,ginsenosides,flavonoids,and phenylpeptides,were identified.Based on the method of plant metabonomics,five main marker compounds among different batches of Guanxinjing Capsules were found;46 active substances were screened by pharmacokinetic index and response intensity.Based on network target analysis,7 compounds were identified as pharmacodynamic substances.Finally,9 compounds including tanshinone IIA,cryptotanshinone,salvianolic acid B,rosmarinic acid,albiflorin,paeoniflorin,ginsenoside Rg1,artemisinolide,hydroxysafflorin A were identified as the Quality marker of Guanxinjing Capsules;The linear range of 9 components in Guanxinjing capsules by HPLC-QTRAP-MS/MS was good?r>0.9922?.The precision,accuracy,stability and recovery rate of the sample method was satisfactory in accordance with the requirements,the total amount of the nine components changed from 20.1543 to 34.3522 mg/g.Conclusion:In this study,the integration of chemical composition-batch difference-pharmaceutical effect-component compatibility was achieved,which realized the discovery of quality markers in Guanxinjing Capsules,and provided feasible ideas for the study of Chinese medicine quality markers.The establishment of quality evaluation methods based on quality markers laid a good foundation for the final development of the scientific and feasible quality standard of Guanxinjing Capsule.