Evaluation of key production process of Baoyuan Decoction Granules based on characteristic chromatograms and quantitative transfer relationship
Objective:To evaluatehe the key production processes of the classic famous prescription Baoyuan Decoction(BYD)Granules based on the characteristic chromatogram and the transfer rates of 4 index components to ensure the equivalence of the granules with the reference sample.Methods:A method was established for the determination of ginsenoside Rb1,calycosin-7-O-glucoside,glycyrrhizic acid and liquiritin in BYD Granules.The characteristic chromatograms of three batches of pilot samples were established with BYD reference samples as reference,and the rationality of the preparation process of BYD Granules was evaluated.Results:The established method for content determination of the four index components was stable and feasible.Compared with the reference samples,the average transfer rates of ginsenoside Rb1,galycosin-7-O-glucoside,glycyrrhizic acid and liquiritin from the tablets to the granules were 76.02%,63.50%,66.99%and 83.54%,respectively,and the transfer rates of the four components were within the range of 70%～130%of the reference samples,and all of them had corresponding characteristic peaks.Conclusion:Through the study of the characteristic chromatogram and the transfer of the index components in each link,it provides a reference basis for the future production and quality control of the classic famous prescription BYD Granules.
classic famous prescriptionBaoyuan Decoctioncharacteristic chromatogramquantitative transfer relationshipkey production processes
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