小儿扶脾颗粒的质量标准研究

Study on the Quality Standard of Xiao'er Fupi Granules

目的建立小儿扶脾颗粒的质量标准。方法采用薄层色谱法对小儿扶脾颗粒中白术、陈皮、莲子进行定性鉴别;采用高效液相色谱法测定了陈皮中橙皮苷的含量:色谱柱为Agilent C_(18)(TC)(250mm×4. 6mm,5μm);流动相为甲醇-水(32∶68);流速0. 8mL·min^(-1);检测波长为283nm。结果薄层色谱斑点清晰,阴性无干扰;高效液相色谱法测定小儿扶脾颗粒中橙皮苷含量,测得橙皮苷对照品进样量在0. 0412~1. 03μg范围内线性关系良好(r=0. 9998),平均加样回收率为101. 84%,RSD为2. 98%。结论该方法简便、准确、重复性好,可以有效控制小儿扶脾颗粒的质量。

OBJECTIVE To establish the quality standard for Xiao′er Fupi Granules. METHODS TLC was used for the qualitative identification of atractylodes macrocephala rhizoma,tangerine peel and lotus seeds.HPLC wasused to determine the content of hesperidin.The separation was performed on anAgilent C 18 （TC） （250mm×4.6mm,5μm）coulme with mobile phase consistingof methanol-water （32∶ 68）.The detection wavelength was 283nm and te flow rate was 0.8mL·min -1 . RESULTS TLC spots were clear and well-separated without negative interference.The linear range of hesperidin was 0.0412～1.03μg（r=0.9998） with an average recovery of 101.84%（RSD=2.98%）.CONCLUSION The method is simple,accurate and reproducibility.Itcan be used for the quality control of Xiao′er Fupi Granules.