银翘解毒颗粒剂的高效液相特征图谱

Study on the characteristic chromatograms of Yinqiao Jiedu granular by HPLC

目的:建立银翘解毒颗粒高效液相特征图谱的测定方法,整体评价银翘解毒颗粒质量。方法:采用色谱柱Kromasil100-5 C18(4.6 mm×250 mm);检测器为DAD检测器;检测波长279 nm;柱温30℃;甲醇-0.2%磷酸为流动相,1 mL·min-1的流速梯度洗脱。结果:模拟银翘解毒颗粒剂特征图谱有13个共有峰,其精密度、重复性、稳定性试验中各共有峰的相对保留时间的RSD均小于0.1%,相对峰面积的RSD均小于6%。模拟颗粒相似度较好,银翘解毒颗粒样品图谱存在较大差异。在已建立特征图谱基础上,归属了3个特征色谱峰及1个组峰作为金银花、牛蒡子、连翘、甘草4味药材的样品特征峰。结论:建立的银翘解毒颗粒HPLC特征图谱分析法,为进一步控制银翘解毒颗粒样品质量提供研究基础。

OBJECTIVE To establish characteristic chromatograms of Yinqiao Jiedu granular by using HPLC for whole quality evaluation of the granular.METHODS The analysis was carried out on C18 column Kromasil 100-5 C18（4.6 mm×250 mm）,the detector was DAD,the detection wavelength was 279 nm,the column temperature was 30 ℃.The gradient elution was methanol and 0.2% phosphoric acid,the flow rate was 1 mL·min-1.RESULTS 13 common peaks were found in the characteristic chromatograms of simulated granular.In precision,reproducibility and stability tests,the RSD of relative retention time of common peaks was less than 0.1%,and the RSD of relative peak area of common peaks was less than 6%.Ten batch of simulated granular samples were of high similarity,and Yinqiao Jiedu granular samples showed more differences in feature graphics.There were 3 peaks and 1 group peak belonging to the characteristic peaks of Lonicerae Flos,Arctii Fructus,Forsythiae Fructus and Glycyrrhizae Radix of Yinqiao Jiedu granular.CONCLUSION The method developed can supply foundation for the study of the quality control of Yinqiao Jiedu granular.