速克感冒胶囊质量标准的建立

【目的】建立速克感冒胶囊的质量标准。【方法】采用薄层鉴别法(thin layer chromatography,TLC)对其处方组成药味野菊花和马来酸氯苯那敏进行定性分析;采用高效液相色谱法(high performance liquid chromatography,HPLC)测定速克感冒胶囊中阿司匹林的含量。色谱柱为C1(8250 mm×4.6 mm,5μm),甲醇-0.03 mol/L磷酸二氢钾(35:65)为流动相,检测波长276 nm,流速1.0 ml/min,进样量为10μl。【结果】TLC鉴别分离度好,阴性对照无干扰;阿司匹林在进样量为1.202~12.020μg范围内具有良好的线性关系,平均回收率为99.68%,RSD为0.30%(n=9)。【结论】本方法准确、灵敏度高、重现性好,适于速克感冒胶囊的质量控制。

Study on the quality standard of SUKEGANMAO capsule

Objective] To establish the quality standard for SUKEGANMAO capsule. Methods] Chrysanthemum indicum L and Chlorphenamine maleate were identified by TLC. HPLC quantitative analysis was carried out on a C18 column（250 mm x 4.6 mm, 5um） with methanol-0.03 mol/L potassium dihydrogen phosphate solution （35：65）,the flow rate was 1.0 ml/min, the detective wavelength was set at 276 nm. The injection volume was 10μl. Results] The TLC spots were clear and separated well without interference of negative sample. The linear rang of aspirin was 1.202-12.020 μg with average rate of recovery 99.68% （ RSD=0.30%, n = 9）. Conclusion ] This method is proved to be simple and reliable and can be used for the quality control of SUKEGANMAO capsule.