含挥发油饮片砂仁标准汤剂的质量评价方法研究OACSTPCD

Objective:To establish a quality evaluation method for the standard decoction of Amomi Fructus decoction pieces based on the extract yield,content and transfer rates of index components,and characteristic chromatogram.Methods:15 batches of standard decoction were prepared according to the requirements.The extract yield and the content of bornyl acetate and volatile oil were determined,and the transfer rates were calculated.The chromatography was performed in a CORTECS T3 column(100 mm×2.1 mm,1.6 μm)with acetonitrile(A)-0.1%phosphoric acid aqueous solution(B)as the mobile phase by gradient elution at the flow rate of 0.35 mL·min-1 and the column temperature of 30℃.The detection wavelength was set at 260 nm.A characteristic chromatogram-based method for evaluating the standard decoction was thus established.Results:The extract yields,bornyl acetate transfer rates,and volatile oil transfer rates in 15 batches of Amomi Fructus samples varied within the ranges of 12.3%-17.7%,3.9%-10.5%,and 5.6%-15.6%,respectively.The characteristic chromatogram of Amomi Fructus standard decoction was collected under the optimal chromatographic conditions,revealing a variety of chemical components.A total of 11 characteristic peaks were marked,and 7 of them were identified by liquid chromatography(LC)-tandem mass spectrometry(MS/MS)and reference substances.Specifically,peaks 1,4,5,7,8,10,and 11 represented protocatechuic acid,vanillic acid,catechin,procyanidin B2,epicatechin,isoquercetin,and quercetin,respectively.According to the similarity evaluation system for chromatographic fingerprint of traditional Chinese medicine(2012 edition),the fingerprint similarity of the 15 batches of Amomi Fructus standard decoction was wihtin the range of 0.984-0.999.The cumulative variance contribution rate of the first two principal components was 81.579%.Conclusion:The method for content determination and the characteristic chromatogram established in this study had good applicability and accuracy.They can comprehensively reflect the intrinsic quality of standard decoction of Amomi Fructus decoction pieces and provide reference for producing the formula granules of Amomi Fructus.