目的 建立HPLC-PDA法測定正天丸和正天膠囊非法添加色素胭脂紅、日落黃、誘惑紅、赤鮮紅、酸性紅73、金橙Ⅱ的方法。方法 樣品用70%乙醇提取，以乙腈-0.02 mol/L醋酸銨梯度洗脫，PDA檢測器檢測。結(jié)果 8批正天丸和4批正天膠囊均未檢出有胭脂紅、日落黃、誘惑紅、赤蘚紅、酸性紅73、金橙Ⅱ。結(jié)論 本實驗采用HPLC-PDA法檢測正天丸和正天膠囊中6種非法添加色素，方法簡單、準(zhǔn)確、快速、重復(fù)性好，可為評價正天丸、正天膠囊的質(zhì)量提供一定的參考。

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、正天膠囊國家藥品評價研究項目