通络糖泰颗粒质量标准研究

摘要

Objective To establish the quality standard for Tongluo Tangtai Granules. Methods TLC was applied to the qualitative identification of Rhizoma Coptidis, Semen Sinapis Albae and Radix Scrophulariae, and HPLC was applied to the quantitative determination of berberine in the prescription. Results Rhizoma Coptidis, Semen Sinapis Albae and Radix Scrophulariae could be detected by TLC, the spots were clear and there was no interference for the negative sample. A good linearity of berberine was showed in the range of 0.037 29-2.610 3 µg (r=1.000 0). The average recovery of berberine was 98.85%, and RSD was 0.70% (n=6). Conclusion The methods are simple, sensitive, accurate with good reproducibility. It can be used for the quality control of Tongluo Tangtai Granules.%目的：建立通络糖泰颗粒的质量标准。方法采用薄层色谱法对制剂中黄连、芥子、玄参进行定性鉴别,采用高效液相色谱法测定通络糖泰颗粒中盐酸小檗碱含量。结果黄连、芥子、玄参薄层色谱斑点清晰,专属性强,阴性对照无干扰。盐酸小檗碱进样量在0.03729～2.6103µg范围内呈良好的线性关系,r＝1.0000,平均回收率为98.85%,RSD＝0.70%(n＝6)。结论该方法灵敏、简便、准确、重复性好,可作为通络糖泰颗粒的质量控制标准。