镇痛宁胶囊的质量标准

Quality Control of Zhentongning Capsules

目的:建立镇痛宁胶囊的质量控制标准。方法:采用薄层色谱法对独活、当归、青风藤进行定性鉴别;采用薄层色谱法对乌头碱进行限量检查;采用高效液相色谱法测定青藤碱的含量。结果:薄层色谱斑点清晰,分离效果好。青藤碱在1～10μg之间呈良好的线性关系(r=0.999 8),平均回收率为99.55%,RSD为1.53%(n=6)。结论:所建立的方法简便、准确、专属性强,可用于镇痛宁胶囊的质量控制。

Objective： To establish the quality control of zhentongning capsules. Method： Radix angelicae pubeseentis,Radix angelicae sinensis and caulis sinomenii in the preparation were identified by TCL; the quantitative limitation of aconitine was identified by TLC ; and the content of Sinomenine was determined by HPLC. Result： The spots in TLC was fairly clear and seperated with each other. Sinomenine was showed a good linear relationship in a range of 1-10 μg （r = 0. 999 8 ）. The average recovery was 99. 55% with RSD 1.53% （ n = 6）. Conclusion ： The methods are simple, accurate and specific, which can be used for the quality control of Zhentongning Capsules.