Comprehensive quality evaluation of Jieyu Anshen granules based on multi-indicator content determination and HPLC characteristic chromatogram combined with chemometrics
Objective:To establish a multi-component content determination and characteristic chromatogram method for Jieyu Anshen granules,combined with chemometrics,to comprehensively evaluate the quality of Jieyu Anshen granules.Methods:The separation was performed on a CAPCELL PAK MG Ⅱ C18(250 mm x4.6 mm,5 μm)column using acetonitrile(A)and 0.1％phosphoric acid aqueous solution(B)as the mobile phases with gradient elution at a flow rate of 1.0 mL·min-1.The column temperature was 30 ℃ and the detection wave-lengths were set at 237 nm and 335 nm.The analysis method was validated.Based on the multi-component con-tent determination method,characteristic chromatogram was established.The samples were analyzed and evaluated through chemometrics to identify the main factors affecting their quality.Results:A multi-component content determination method was established for Jieyu Anshen granules.The five components had good linear relation-ships within their respective ranges,with recovery rates ranging from 95.6％to 100.0％.And 145 batches of samples were tested,and a total of 54 batches were found to be unqualified,with a total unqualified rate of 37.2％.Establishing a characteristic chromatogram of Anshen granules,12 characteristic peaks were attributed to 6 medicinal herbs.Through chemometric analysis,it was found that there were certain differences in the quality of samples from 10 manufacturers.The quality of fried gardenia and stir-baked licorice was the key factor.Conclu-sion:The established multi-component content determination method and characteristic chromatogram method for Jieyu Anshen granules are convenient and reliable,and can be used for comprehensive evaluation of the quality of Jieyu Anshen granules.
万方数据
维普
