补肾壮阳类中药制剂中非法添加化学药物成分的检测

目的采用液质联用法检测补肾壮阳类中药制剂中非法添加的化学成分西地那非、他达拉非。方法色谱柱为AcquityBEHC18柱（2.1mm×50 mm,1.7μm）,以0.01 mol/L的醋酸铵溶液-乙腈梯度洗脱,流速0.3 mL/min,检测波长254 nm。结果在3批补肾壮阳类中药制剂中检测出西地那非或他达拉非。结论液质联用法灵敏准确,可有于补肾壮阳类中药制剂的质量检验。

Determination of Chemical Components Illegally Added in Traditional Chinese Medicines for Invigorating Kidney and Strengthening Yang

Objective To establish a UPLC /MS /MS method for the determination of sildenafil and tadalafil illegally adulterated into tra-ditional Chinese medicines for invigorating the kidney and strengthening Yang.Methods The chromatographic conditions included the Ac-quity BEH C18 column（2.1 mm × 50 mm,1.7 μm）,the mobile phase of 0.01 mol/L ammonium acetate（A）-acetonitrile（B） for gradient elu-tion,the flowing rate of 0.3 mL/min and the detection wavelength of 254 nm.Results Illegally mixed sildenafil and tadalafil were separated well and found in 3 batches of samples of Chinese medicines for invigorating the kidney and strengthening Yang under the selected chro-matographic conditions.Conclusion The method is proved to be sensitive and accurate,which could be used for the quality control and the assurance of the traditional Chinese medicines for invigorating the kidney and strengthening Yang.