小儿健脾丸质量标准研究

Quality Standard of Xiao'er Jianpi Pills

目的建立小儿健脾丸的质量标准。方法采用薄层色谱(TLC)法对小儿健脾丸中陈皮进行定性鉴别;采用高效液相色谱法测定甘草酸的含量,色谱柱为Agilent Zorbax SB-C_(18)柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.2%磷酸水溶液(35∶65,V/V),流速为1.0 m L/min,检测波长为250 nm,柱温为25℃,进样量为10μL。结果陈皮的TLC图谱斑点清晰,专属性强,且阴性对照无干扰。甘草酸铵进样量在0.0049~0.0369μg范围内与峰面积线性关系良好(r=0.9999,n=5),精密度、稳定性、重复性试验的RSD均小于2.0%(n=6),平均加样回收率为97.83%,RSD为0.94%(n=6);样品中甘草酸的平均含量为0.3867 mg/g。结论该方法操作简便,结果准确,专属性强,稳定性和重复性均较好,可用于小儿健脾丸的质量控制。

Objective To establish the quality standard of Xiao'er Jianpi Pills.Methods Thin-layer chromatography(TCL)method was used for the qualitative identification of Citri Reticulatae Pericarpium in Xiao'er Jianpi Pills.High-performance liquid chromatography(HPLC)method was used for the content determination of glycyrrhizic acid in Xiao'er Jianpi Pills,the chromatographic column was Agilent Zorbax SB-C_(18) column(250 mm×4.6 mm,5μm),the mobile phase was acetonitrile-0.2%phosphoric acid(35∶65,V/V),the flow rate was 1.0 m L/min,the detection wavelength was 250 nm,the column temperature was 25℃,and the injection volume was 10μL.Results The TLC spots of Citri Reticulatae Pericarpium were clear and specific,and the negative control had no inter-ference.The linear range of ammonium glycyrrhizinate was 0.0049-0.0369μg(r=0.9999,n=5).The RSDs of precision,stability and repeatability tests were less than 2.0%(n=6).The average recovery of ammonium glycyrrhizinate was 97.83%with the RSD of 0.94%(n=6).The average content of glycyrrhizic acid in the samples was 0.3867 mg/g.Conclusion The method established in this study is simple,accurate,specific,stable and reproducible,which can be used for the quality control of Xiao'er Jianpi Pills.