舒筋通络外用颗粒的质量标准研究

目的:建立舒筋通络外用颗粒的质量标准。方法:采用薄层色谱(TLC)法对舒筋通络外用颗粒中的当归、桂枝、独活、大黄进行定性鉴别;采用高效液相色谱法测定主药大黄中有效成分大黄素、大黄酚的含量。结果:TLC斑点清晰、分离度好,阴性对照无干扰;大黄素、大黄酚进样量分别在0.01～0.50、0.025～1.250μg范围内与各自峰面积积分值呈良好线性关系(r均为0.9999),平均回收率分别为102.3%、100.4%,RSD分别为0.5%、1.5%(n均为6)。结论:所建标准可用于该制剂的质量控制。

Quality Standard of Shujin Tongluo Granules for External Use

OBJECTIVE： To establish a quality standard of Shujin tongluo granules for external use. METHODS： The identification of Angelica sinensis, Cinnamomum cassia, Angelica pubescens and Rhei Radix Et Rhizoma was carded out by TLC. The contents of emodin and chrysophanol were determined by HPLC. RESULTS： TLC spots were clear and well-separated without interference of negative sample. The linear range of emodin was 0.01-0.50 μg（r=0.9999） with an average recovery of 102.3% （RSD=0.5%, n=6）. The linear range of chrysophanol was 0.025-1.250 μg （r=0.9999） with an average recovery of 100.4% （RSD=1.5% ,n=6）. CONCLUSION：Established standard is suitable for the quality control of Shujin tongluo granules for external use.