舒筋活血胶囊质量标准研究

Study on Quality Criteria of Shujin Huoxue Capsules

目的建立舒筋活血胶囊的质量标准。方法采用薄层色谱法(TLC)对制剂中的香附、红花和香加皮进行鉴别,采用高效液相色谱法(HPLC)测定制剂中4-甲氧基水杨醛的含量。结果TLC能较好地鉴别制剂中的香附、红花和香加皮;HPLC法能准确测定出制剂中4-甲氧基水杨醛的含量,其在2-75μg/ml范围之间呈良好的线性关系,平均回收率为96.6%(RSD=0.78%)。结论所建立的方法简单可行,能快速准确地对舒筋活血胶囊进行鉴别和含量测定。

Objective To establish the quality criteria of Shujin Huoxue Capsules. Methods Rhizoma Cyperi, Carthamus tinctorius and Cortex Periplocae in Shujin Huoxue Capsules were identified by thin layer chromatography（TLC）. 4-methoxysalicylal was determined by HPLC. Results The characteristic identification of Rhizoma Cyperi, Carthamus tinctorius and Cortex Periplocae by TLC was distinct and highly specific. The linear range of 4-methoxysalicylal for quantitative evaluation was 2-75μg/ml and the average recovery was 96.6%（RSD=0. 78%）. Conclusion This established method is accurate for controlling the quality of Shujin Huoxue Capsules.