Quality Evaluation of Dashanzha Pills Based on HPLC Fingerprint and Multi-Component Analysis Com-bined with Chemical Pattern Recognition
OBJECTIVE To establish the HPLC fingerprints and content determination method of five index components of Das-hanzha pills(DSZP),and evaluate the quality combined with chemical pattern recognition.METHODS The analysis was performed on an Eclipse plus C18 column(4.6 mm ×250 mm,5 μm)at 30 ℃.Acetonitrile-0.1％formic acid aqueous solution was used as the mobile phase for gradient elution at flow rate of 1.0 mL·min-1.The detection wavelength was set at 250 nm,and the injection volume was 10 μL.Based on 51 batches of DSZP samples,the fingerprint was established,and five index components were identified and quantitatively determined.Cluster analysis,principal component analysis and orthogonal partial least squares discriminant analysis were used to comprehensively analyze 51 batches of samples.RESULTS The fingerprints of DSZP were established,sixteen peaks were i-dentified,and five chemical components were identified.They were chlorogenic acid(peak 5),vanillic acid(peak 6),hyperoside(peak 7),isochlorogenic acid B(peak 9),and isochlorogenic acid A(peak 10).The linear relationship of the five index components was good(r＞0.998),and the recovery rate was 96.27％-109.35％,and the RSD was 2.83％-4.07％.The contents of chloro-genic acid,vanillicacid,hyperoside,isochlorogenic acid B,and isochlorogenic acid A were 0.047 2-0.227 0,0.009 7-0.036 2,0.023 0-0.370 2,0.006 4-0.063 2 and 0.021 7-0.064 5 mg·g-1,respectively.Except for manufacturer Q2,the contents of the products from the other manufacturers samples were maintained at(100±30)％of their respective average values,and the con-tents of the five components of manufacturer Q2 were mostly higher than 30％of the average value of all samples,indicating that there were great differences in product quality among different enterprises.The results of chemical pattern recognition showed that all samples could be roughly divided into two categories,indicating that the preparation process was relatively stable within the enterprise,but there were some differences between enterprises.The difference markers of the screened samples included the target components chlorogenic acid,hyperoside,and isochlorogenic acid B.CONCLUSION The quantitative method is accurate,rapid and feasible.Combined with chemical pattern recognition method,it can be used to evaluate the quality of DSZP.
Dashanzha pillHPLC fingerprintchemical pattern recognitionquality controlhyperosideisochlorogenic acid B
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