舒筋通络外用颗粒质量标准的研究

Study on quality standard for Shujin Tongluo Granules

目的:建立舒筋通络外用颗粒的质量标准。方法:采用薄层鉴别法对制剂中的当归、桂枝、独活、大黄进行定性鉴别;用高效液相色谱法测定大黄素、大黄酚的含量。结果:薄层色谱可明显地检出当归、桂枝、独活、大黄;高效液相色谱法测得大黄素、大黄酚含量之和为34.50～35.24mg/15g,大黄素在0.010～0.500μg范围内线性关系良好(r=0.9999),平均回收率为102.3%,RSD为0.93%(n=6);大黄酚在0.025～1.250μg范围内线性关系良好(r=0.9999),平均回收率为100.4%,RSD为1.30%(n=6)。结论:本方法简单、准确、专属性好,可用于舒筋通络外用颗粒的质量控制。

Objective： To establish the quality standard for Shujin Tongluo Granules. Method： Radix Angelicae Sinensis, Ramulus Cinnamomi, Radix Angelicae Pubescentis, Radix et Rhizoma Rhei in this medicine were identified by TLC. The content of Emodin and Chrysophanol in this medicine was determined by HPLC. Result： Radix Angelicae Sinensis, Ramulus Cinnamomi, Radix Angelicae Pubescentis, Radix et Rhizoma Rhei could be identified by TLC. The total content of Emodin and Chrysophanol were 34.50-35.24 mg per 15 g, the linear ranges of Emodin was at 0.010-0.500 μg （r=0.999 9）, the average recovery was 102.3% with a RSD of 0.93% （n=6）; the linear ranges of Chrysophanol was at 0.025-1.250 μg （r=0.999 9）, the average recovery was 100.4% with a RSD of 1.30%. Conclusion： The method is simple, accurate, and can be used for the quality control of Shujin Tongluo Granules.