目的 建立HPLC-PDA法测定正天丸和正天胶囊非法添加色素胭脂红、日落黄、诱惑红、赤鲜红、酸性红73、金橙Ⅱ的方法。方法 样品用70%乙醇提取，以乙腈-0.02 mol/L醋酸铵梯度洗脱，PDA检测器检测。结果 8批正天丸和4批正天胶囊均未检出有胭脂红、日落黄、诱惑红、赤藓红、酸性红73、金橙Ⅱ。结论 本实验采用HPLC-PDA法检测正天丸和正天胶囊中6种非法添加色素，方法简单、准确、快速、重复性好，可为评价正天丸、正天胶囊的质量提供一定的参考。

Objective To establish a rapid determination of six pigments (coccinellin, sunset yellow, allura red, erythrosine, acid red 73, and Orange Ⅱ) illegally added in Zhengtian Pill and Zhengtian Capsule. Methods The samples were extracted by 70% ethanol, gradient eluting with acetonitrile-0.02 mol/L ammonium acetate and then detected by PDA. Results No pigment was detected in Zhentian Pill or Zhengtian Capsule. Conclusion This method is simple, accurate, rapid, and reproducible, and it could be used for evaluating the quality of Zhengtian Pill and Zhengtian Capsule.

正天丸、正天胶囊国家药品评价研究项目