止泻灵糖浆质量标准提升及特征图谱研究

Improving on Quality Standard and Specific Chromatogram of Zhixieling Syrup

目的:提高止泻灵糖浆质量标准,更全面控制产品质量。方法:新增止泻灵糖浆中五倍子和陈皮的薄层色谱定性鉴别;采用高效液相色谱法(HPLC)测定主要成分橙皮苷的含量,并建立乙酸乙酯部位特征图谱,所用色谱柱为Waters symmetry shield C_(18)(250 mm×4.6 mm,5μm),检测波长为283 nm,以乙腈-6%醋酸为流动相,梯度洗脱。结果:新增的薄层色谱鉴别斑点清晰,阴性对照无干扰;橙皮苷含量在0.190765~3.815292μg范围内线性关系良好,平均回收率101.63%(RSD=0.77%);特征图谱显示有10个共有峰,相似度大于0.9。结论:文章所建薄层色谱鉴别方法具有较好的专属性和重现性;橙皮苷的含量测定方法具有较好的准确性和重复性,为止泻灵糖浆的质量提升提供依据。

Objective To improve the quality standard for Zhixieling syrup.Methods TLC was adopted in the qualitative identification of Galla Chinensisand Pericarpium Citri Reticulatae,HPLC was used for the content determination of Hesperidin in Zhixieling syrup,and the characteristic spectrum was established with ten peaks were defined as common peak.The determination was developed on Waters symmetry C_(18)(250 mm×4.6 mm,5μm),acetonitrile-2%acetic acid was used as mobile phases.Results TLC identification method with significant specificity,the Hesperidin have a good linear relationship with in the ranges from 0.190765μg to 3.815292μg,and average recovery was 101.63%(RSD=0.77%).The characteristic spectrum was established with 10 common peaks,and the similarities of the sample's chromatograms compared with the references were higher than 0.9.Conclusion The established methods of TLC are excluesivity and reproducibility;the content determination of Hesperidin is accuracy and repeatability,which can be used for the quality control of Zhixieling syrup.