益母草颗粒的质量标准

Quality Standard for Herba Leonuri Granules

目的:建立益母草颗粒质量控制方法。方法:用薄层色谱法对益母草进行鉴别;采用HPLC-ELSD测定益母草中盐酸水苏碱的含量。结果:薄层色谱鉴别斑点清晰,易于观察,盐酸水苏碱在460～23000 ng范围内(r=0.998 6)线性关系良好。平均加样回收率为99.1%(RSD=1.6%)。结论:方法操作简便,可行,重复性好,可作为制剂的质量控制。

Objective： To establish a method for quality control of herba leonuri granules. Method： The herba leonuri granules was identified by TLC,the content of stachydrine hydrochloride was determined by HPLC-ELSD. Result： The spots in the TLC was clear and distinguished well, the linear range of stachydrine hydrochloride was 460ng - 23000 ng（ r = 0.998 6）. The average recovery was 99.1% ,RSD = 1.6% （ n = 6）. Conclusion： The method is simple, feasible and repeatable, it can be used for the quality cantrol of herba leonuri Granules.