脊痛安片质量标准的研究

STUDIES ON QUALITY STANDARD OF JITONGAN TABLETS

目的建立脊痛安片质量控制方法。方法采用薄层色谱法对马钱子、苍术、麻黄、川牛膝和甘草进行定性鉴别,采用高效液相色谱法测定马钱子中士的宁的含量。色镨条件为C_(18)柱;流动相乙腈-0.01mol/L三乙胺溶液(用磷酸调pH值至2.6)(18:82);流速1.0mL/min;检测波长254nm。结果薄层色谱斑点清晰集中,士的宁在5.52～18.4mg/L范围内具有良好线性关系,平均回收率为99.13%,相对标准差=1.82%(n=5)。结论高效液相色谱方法灵敏、准确、重视性好、专属性强,可作为脊痛安片的质量控制标准。

Objective To establish a method for quality control of Jitongan Tablets. Methods Semen Strychni, Rhizoma Atractylodis, Herba Ephedrae, Radix Cyathulae and Radix et Rhizoma Glycyrrhizae were identified by thin layer chromatography （TLC）. The content of strychnine was determined by high performance liquid chromatography（ HPLC ）. HPLC was performed on C18 column, the mobile phase was a mixture of acetonitrile -0.01 mol/L triethylamine （adjust pH to 2.6 by H3 PO4 ） （18： 82） , the flow rate was 1.0mL/min, and detection wave length at 254nm. Results The spots of TLC were clear and concentrative. There was a good linear relationship for strychnine within the range of 5.52 - 18.4mg/L. The average recovery was 99.13% , relative standard deviation = 1.82% （ n = 5 ）. Conclusion This method was found to be sensitive, accurate, reproducible and exclusive. It can be used for quality control of Jitongan Tablets.