HPLC多组分定量结合化学计量学及灰色关联度的葆宫止血颗粒质量评价OACSTPCD

Objective:To develop an High Performance Liquid Chromatography(HPLC)method for the simultaneous determination of 13 components in Baogong Zhixue Granule,and to comprehensively evaluate the quality of Baogong Zhixue Granule by chemometrics and grey relational analysis(GRA).Methods:The Baogong Zhixue Granule samples were extracted with 50%methanol solution under ultrasonic condition.The chromatographic separation was performed on a CAPCELL PAK C18 column and gradient elution was carried out with acetonitrile-0.2%phosphoric acid aqueous solution as the mobile phase.The contents of catalpol,rehmannioside D,rehmannioside A,leonuride,notoginsenoside R1,ginsenoside Rg1,ginsenoside Rb1,saikosaponin a,saikosaponin d,albiflorin,paeoniflorin,benzoylpaeoniflorin and agrimophol in Baogong Zhixue Granule were determined.Chemometrics was used to explorethe potential markers affecting the product quality of Baogong Zhixue Granule.The relative correlation degree of each index was calculated by GRA method,and the quality of 13 batches of Baogong Zhixue Granule was sorted.Results:The linear ranges of 13 components were 2.68-134.00,1.64-82.00,0.88-44.00,0.57-28.50,2.35-117.50,11.93-596.50,9.71-485.50,2.05-102.50,1.86-93.00,9.62-481.00,19.05-952.50,1.78-89.00 and 0.66-33.00 µg·mL-1(r>0.999),respectively,and the average recoveries of three mass concentration ranged from 96.78%-100.12%with RSD<2.0%.Chemometric analysis showed that paeoniflorin,ginsenoside Rg1,albiflorin,ginsenoside Rb1,catalpol,saikosaponin a and notoginsenoside R1 were the main potential markers affecting the quality of Baogong Zhixue Granule.The relative correlation degree was 0.344 6-0.574 2.Conclusion:This method revealed the main potential markers affecting the quality of Baogong Zhixue Granules,comprehensively evaluated the quality of Baogong Zhixue Granules,and provided a reference for its internal and overall quality control.