地龙舒腰胶囊的质量标准研究

Quality Standard of Dilong Shuyao Capsules

建立了HPLC法测定地龙舒腰胶囊中薯蓣皂苷的含量。采用C18色谱柱,以乙腈-水(50∶50)为流动相。结果表明,薯蓣皂苷在7.2～720 g/ml范围内线性关系良好,平均加样回收率为103.4%。以亮氨酸和缬氨酸为对照,采用薄层色谱法鉴别了胶囊中的地龙,结果色谱斑点清晰,阴性无干扰。采用UV法对其中双酯型生物碱进行限度检查。结果 3批胶囊中双酯型生物碱均低于0.15%(以乌头碱计)。

An HPLC method was established for the determination of dioscin in Dilong Shuyao capsules. A C18 column was used with the mobile phase of acetonitrile-water （50 ： 50）. The calibration curve of dioscin was linear in the range of 7.2 - 720 μg/ml. The average sample recovery was 103.4%. The Pheretima aspergillum in capsules was qualitatively identified by TLC with leucine and valine as the control. The TLC spots were clearly detected with no interference from negative sample. The limit of the diester-diterpenoid alkaloids were determined by UV method. The results showed that the diester-diterpenoid alkaloids content of three batches of capsules were less than 0.15 % （based on aconitine）.