合欢花饮片标准汤剂质量标准评价的建立

Establishment of Quality Standard Evaluation for Flos Albiziae Standard Decoction

目的:制备合欢花饮片标准汤剂,测定合欢花标准汤剂中槲皮苷的含量,并建立指纹图谱,以进行质量研究。方法:依照标准汤剂的制备要求,制备15批不同产地的合欢花饮片标准汤剂,以槲皮苷作为定量检测指标,计算转移率与出膏率,并建立其UPLC特征图谱分析方法。结果:通过对15批合欢花标准汤剂进行测定,槲皮苷转移率为72.33%～41.51%,出膏率为26.6%～23.4%;并用中药色谱指纹图谱相似度评价系统软件进行特征图谱分析,标定了其中5个共有峰,对15批合欢花饮片标准汤剂分别进行了相似度评价,其相似度均大于0.90。结论:合欢花饮片标准汤剂制备规范,测定方法精密度、稳定性和重复性良好,可为合欢花配方颗粒的质量控制提供参考。

Objective:To prepare Flos Albiziae standard decoction and determine the content of quercetin in standard decoction and establish chromatographic fingerprint for studying the quality standard decoction.Methods:Fifteen batches of Flos Albiziae standard decoctions were prepared according to the standardization method.With quercetin as the detection index,the transfer rate and extraction rate were calculated and a UPLC characteristic chromatograms analysis method was established.Results:According to the measurement of 15 batches of standard decoctions,the transfer rate ranged from 72.33%to41.51%and extract rate was at the range of 26.6%to 23.4%.Besides,the Similarity Evaluation System for Chromatographic Fingerprint of traditional Chinese medicine TCM was used to analyze and compare the characteristic chromatograms,five peaks were calibrated.Moreover,the similarity of fifteen batches was over 0.90.Conclusion:Samples were prepared by a standard method.The method displayed a good precision stability and repeatability.Therefore,this study can provide a reference for the quality control of Flos Albiziae formula granules.