健脾止嗽颗粒质量标准研究

Study on the Quality Standard of Jianpizhisou Granules

目的建立健脾止嗽颗粒的质量标准。方法采用薄层色谱法定性鉴别健脾止嗽颗粒中的苍术、木香,采用高效液相色谱法测定橙皮苷含量。色谱柱为Elipse XDB-C18柱(150 mm×4.6 mm,5μm),流动相为甲醇-水(60∶40),检测波长283 nm,流速1.0 mL/min,柱温25℃。结果薄层色谱斑点清晰,阴性无干扰;橙皮苷质量浓度在31.04～155.20μg/mL范围内与峰面积线性关系良好,r=0.999 6(n=5),平均加样回收率为98.35%,RSD=1.64%(n=6)。结论定性定量方法简便、准确、可靠,可作为健脾止嗽颗粒的质量控制方法。

Objective To establish quality standards for Jianpizhisou Granules. Methods TLC was used to distinguish Cangzhu, Muxiang, HPLC was used for the determination of hesperidin. The column was Elipse XDB-C18 colunm（150 mm×4.6 mm,5μm）; mobile phase was methanol-water （60：40）; the detection wavelength was at 283 nm; flow rate at 1.0 mL/min and column temperature at 25℃ respectively. Results The TLC spots were clear and non-interference; hesperidin show a good linear relationship in the range of 31.04- 155.20 μg/mL, r = 0. 999 6 （ n = 5）, the average recovery was 98.35% with RSD = 1.64% （ n = 6）. Conclusion The method is accurate, simple, reliable and can be used as quality control for Jianpizhisou Granules.