Quantitative Value Transfer of Key Quality Attributes of Benchmark Samples of Classical Prescription Qingfei Decoction
Objective:To establish the characteristic chromatogram and index component content determination method for Qingfei Decoction benchmark samples,and clarify the key quality attributes of Qingfei Decoction.Methods:Fifteen batches of Qingfei Decoction benchmark samples were prepared.The HPLC characteristic chromatogram method was established,followed by characteristic peak attribution and similarity analysis.A multi-component content determination method for Qingfei Decoction was established using amygdalin,geniposide,hesperidin,baicalin,wogonoside,baicalein,and glycyrrhizic acid as indicator components.The content and transfer rates of the indicator components were analyzed,and 70%-130%of the average mass was regarded as the limit for the quantity value range of quality control indexes.Results:The similarity of the 15 batches of Qingfei Decoction benchmark samples was 0.986-0.999,with a total of 16 characteristic peaks.Twelve characteristic peaks were identified using reference substances:genipin 1-gentiobioside,amygdalin,geniposide,hesperidin,baicalin,norwogonoside,oroxylin A-7-O-β-D-glucuronide,wogonoside,baicalein,wogonin,schisandrin,and oroxylin A.The transfer rates from the decoction pieces to the benchmark samples were 24.35%-33.13%for amygdalin,36.78%-49.55%for geniposide,23.11%-35.92%for hesperidin,60.62%-74.15%for baicalin,61.81%-76.90%for wogonoside,9.21%-15.77%for baicalein,and 10.35%-18.46%for glycyrrhizic acid.Conclusion:The characteristic chromatogram combined with the content determination of multiple index components was used to study the value transfer law of the benchmark samples of Qingfei Decoction.The method showed good reproducibility,simplicity,accuracy,and stability,providing a reference for the quality control of the classical prescription Qingfei Decoction benchmark samples and the development of Qingfei Decoction compound formulations.
famous classical prescriptionQingfei Decoctionsubstance benchmarkcharacteristic chromatogramcontent determinationquality value transfer
万方数据
维普
