利肾胶囊的质量标准研究

Study on Quality Standard of Lishen Capsule

目的建立利肾胶囊的质量控制方法。方法采用薄层色谱法对方中木贼,鱼腥草进行定性鉴别,采用高效液相色谱法测定利肾胶囊中主要成分山奈素的含量。结果薄层色谱特征斑点清晰,专属性强,阴性对照无干扰;高效液相色谱法测定山奈素含量0.04～0.40μg在范围内线性关系良好(r=0.9999),平均回收率为98.73%,RSD=1.69%。结论该方法简便可靠、专属性强、重复性好,可用于该制剂的质量控制。

Objeefive To establish the method to control the quality of Lishen Capsule. Methods Equiseum and houttuynia in the preparation were identified by TLC.The content of kaempferol which is the effective substance in the preparation was determined by HPLC. Results Above herbs could be detected by TLC. The linear correlation of the kaempferol was good in the range of 0.04-0.40μg （1=0.9999） and the recovery was 98.73%（RSD=1.69%）.Conelusion The method is feasible with good specificity and reproducibility, and can be applied to quality control of the production.