金茵利胆口服液高效液相色谱指纹图谱及多成分含量同时测定研究

目的建立金茵利胆口服液的高效液相色谱(HPLC)指纹图谱,以及多成分含量同时测定的方法。方法色谱柱为DIKMA Diamonsil■C₁₈柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.1%磷酸水溶液(梯度洗脱),流速为0.9 mL/min,检测波长为254 nm,柱温为25℃,进样量为20μL。采用"中药色谱指纹图谱相似度评价系统(2012版)"绘制21批样品的特征图谱,计算相似度;确定共有峰并指认,进行主成分分析,并同时测定8种成分的含量。结果21批样品的特征图谱共有18个共有峰,指认出其中8个特征峰,相似度均不小于0.947,不同批次样品中没食子酸、夏佛塔苷、新橙皮苷、盐酸小檗碱、甘草酸铵在3种主成分中得分较高,8批样品中没食子酸、绿原酸、夏佛塔苷、甘草苷、柚皮苷、新橙皮苷、盐酸小檗碱、甘草酸铵平均含量分别为0.1361,0.1193,0.0919,0.1987,1.3905,1.6550,0.0899,0.0289 g/L。结论所建立的HPLC指纹图谱及8种成分含量同时测定的方法可用于金茵利胆口服液的质量控制。

HPLC Fingerprint of Jinyin Lidan Oral Liquid and Simultaneous Determination of Multiple Components in Jinyin Lidan Oral Liquid

Objective To establish a high-performance liquid chromatography(HPLC)fingerprint of Jinyin Li dan Oral Liquid and an HPLC method for the simultaneous determination of multiple components in Jinyin Lidan Oral Liquid.Methods DIKMA Diamonsil■C₁₈ column(250 mm×4.6 mm,5μm)was adopted,the mobile phase was acetonitrile-0.1%phosphoric acid aqueous solution(gradient elution),the flow rate was 0.9 mL/min,the detection wavelength was 254 nm,the column temperature was 25℃,and the injection volume was 20μL.The Similarity Evaluation System for TCM Chromatographic Fingerprint(2012 Edition)was used to construct the characteristic spectra of 21 batches of samples to calculate the similarity.The common peaks were determined and identified,the principal component analysis was conducted,and the contents of eight components were simultaneously determined.Results There were 18 common peaks in the HPLC fingerprints of 21 batches of samples with similarities≥0.947,of which eight common peaks were identified.Gallic acid,schaftoside,neohesperidin,berberine hydrochloride and ammonium glycyrrhizate scored higher in the three principal components in different batches of samples.The average contents of gallic acid,chlorogenic acid,schaftoside,glycyrrhizin,naringin,neohesperidin,berberine hydrochloride,and ammonium glycyrrhizinate in the eight batches of Jinyin Lidan Oral Liquid were 0.1361,0.1193,0.0919,0.1987,1.3905,1.6550,0.0899,0.0289 g/L,respectively.Conclusion The established HPLC fingerprint and the method for simultaneous determination of eight components can be used for the quality control of Jinyin Lidan Oral Liquid.