目的建立快速、准确的检测中药制剂及保健品中违禁添加降糖药物的分析方法。方法采用C₁₈柱分离,以甲醇-10mmol·L^-1醋酸铵缓冲溶液(0.1%甲酸)为流动相进行梯度洗脱,流速0.2mL·min^-1,离子源为ESI源,正离子检测,对中药中非法添加格列本脲、格列吡嗪、格列美脲、格列奇特、瑞格列奈、盐酸吡格列酮、盐酸二甲双胍进行定性检测。结果5批受试制剂中有1批检测到违禁添加格列本脲。结论此方法选择性强、灵敏度高,可作为分析中药制剂中违禁添加格列本脲、格列吡嗪、格列美脲、格列奇特、瑞格列奈、盐酸吡格列酮、盐酸二甲双胍的有效检测方法。

OBJECTIVE To establish a UPLC-MS/MS method for simultaneous detection of seven anti-diabetic medicines of metformin hydrochloride,pioglitazone hydrochloride,glipizide,gliclazide,glibenclamide,glimepiride and repaglinide,which were illegally added into traditional Chinese medicines and health foods.METHODS A C₁₈ column was used,with the mobile phase of 10 mmol·L^-1 ammonium acetate(0.1% formic acid)and methanol by gradient elution.The flow rate was 0.2 mL·min^-1.It is based on ultra high-performance liquid chromatography with electrospray ionization tandem mass(UPLC-ESI-MS/MS)spectrometric detection in positive ionization mode.RESULTS Glibenclamide was found in one formulation of five.CONCLUSION The method is selective and sensitive and can be used to detect 7 anti-diabetic medicines in traditional Chinese medicines and health foods.