基于高效液相色谱多指标成分分析的化学计量学评价补气养血颗粒质量OA

Objective To establish a high-performance liquid chromatography(HPLC)method for the simultaneous determination of 14 components in Buqi Yangxue Granules,and to evaluate its quality.Methods The chromatographic column was Prep Scalar C18 column(250 mm×4.6 mm,5 μm),the mobile phase was acetonitrile-0.2%phosphoric acid solution(gradient elution),the flow rate was 1.0 mL/min,the detection wavelengths were 230 nm(albiflorin,paeoniflorin,benzoylpaeoniflorin),210 nm(catalpol,rehmannioside D,ginsenoside Rg1,ginsenoside Re,ginsenoside Rb1),260 nm(calycosin 7-O-β-D-glucopyranoside,ononin,isomucronulatol 7-O-β-glucoside),and 280 nm(senkyunolide H,senkyunolide I,senkyunolide A),the column temperature was 30℃,and the injection volume was 10 μL.Principal component analysis(PCA)and orthogonal partial least squares-discriminant analysis(OPLS-DA)were used to screen differential markers,and the Technique for Order Preference by Similarity to an Ideal Solution(TOPSIS)method was used to evaluate sample quality.Results The above 14 components had good linear relationships with peak area within their respective mass concentration ranges(r≥0.999 1,n=6).The RSDs of precision,stability,and repeatability tests were all lower than 2%.The recovery rate of the above 14 components in the range of 96.83%-100.18%,with RSDs of 0.69%-1.82%(n=9).The contents of the above 14 components in 18 batches of samples were in the ranges of 0.370-0.630 mg/g,0.630-1.080 mg/g,0.045-0.089 mg/g,0.260-0.500 mg/g,0.070-0.150 mg/g,0.150-0.260 mg/g,0.300-0.520 mg/g,0.150-0.440 mg/g,0.075-0.270 mg/g,0.060-0.101 mg/g,0.021-0.037 mg/g,0.035-0.059 mg/g,0.079-0.160 mg/g,and 0.220-0.380 mg/g,respectively.PCA and OPLS-DA results indicated that the 18 batches of samples were clustered into three categories.Paeoniflorin,senkyunolide I,ginsenoside Rb1,rehmannioside D,catalpol,albiflorin,ginsenoside Re,and calycosin 7-O-β-D-glucopyranoside were identified as differential markers affecting sample quality.The relative closeness index(Ci)of the 18 batches of samples ranged from 0.321 0 to 0.734 2,with Ci>0.5 for six batches of samples.Conclusion The method is simple,scientific and intuitive,and can be used for the comprehensive evaluation of the quality of Buqi Yangxue Granules.There are some differences in the quality of samples from different batches.