TPU输液器中MDI、抗氧剂1076和环己酮的溶出研究

目的：建立二苯基甲烷二异氰酸酯（MDI）、抗氧剂1076和环己酮的痕量检测方法，对一次性使用聚氨酯输液器中MDI、抗氧剂1076和环己酮的溶出进行研究。方法：环己酮采用气相色谱法，HP-1石英毛细管柱（30 m×0.53 mm），柱温：70℃；抗氧剂1076采用Eclipse XDB-C₁₈色谱柱，以乙腈-四氢呋喃-水（65∶30∶5）为流动相，277 nm作为检测波长；MDI采用Eclipse XDB-C₁₈色谱柱，以乙腈-磷酸二氢钾溶液（0.05 mol·L^-1）（40∶60）为流动相，245 nm作为检测波长。结果：环己酮在0.343 2~6.865 μg·mL^-1浓度范围内线性关系良好（r=0.999 9），平均回收率为95.4%，检测下限为0.103 0 μg ·mL^-1；抗氧剂1076在0.028 82~40.04 μg ·mL^-1浓度范围内线性关系良好（r=0.999 9），平均回收率为97.5%，检测下限为0.011 53 μg·mL^-1；MDI在6.030~10 050 ng·mL^-1浓度范围内线性关系良好（r=0.999 9），平均回收率为100.2%，检测下限为2.010 ng·mL^-1；环己酮和抗氧剂1076在乙醇溶液中有微量溶出（0.577 3 μg·mL^-1、0.120 1 μg·mL^-1）。结论：本文建立的方法灵敏度高，重复性好，适合对聚氨酯输液器中MDI、抗氧剂1076和环己酮的溶出进行检测；聚氨酯输液器材料中的添加剂溶出量较低。

Objective: To establish a method for determination of trace MDI, antioxidant 1076 and cyclohexanone, and to carry out the research on the dissolution of MDI, antioxidant 1076 and cyclohexanone from disposable TPU infusion device.Methods: Cyclohexanone:HP-1 column was adopted;The temperature of column was 70℃.Antioxidant 1076:Eclipse XDB-C₁₈ column was adopted;The mobile phase consisted of acetonitrile-THF-water (65:30:5);The detection wavelength was 277 nm.MDI:Eclipse XDB-C₁₈ column was adopted;The mobile phase consisted of acetonitrile-Potassium dihydrogen phosphate solution (0.05 mol·L^-1) (40:60);The detection wavelength was 245 nm.Results: The calibration curves of cyclohexanone were linear over the range of 0.343 2-6.865 μg·mL^-1 (r=0.999 9).The average recovery was 95.4%.The values of quantitation limit were 0.103 0 μg·mL^-1.The calibration curves of antioxidant 1076 were linear over the range of 0.028 82-40.04 μg·mL^-1 (r=0.999 9).The average recovery were 97.5%.The values of quantitation limit were 0.011 53 μg·mL^-1.The calibration curves of MDI were linear over the range of 6.030-10 050 ng·mL^-1 (r=0.999 9).The average recovery was 100.2%.The values of quantitation limit were 2.010 ng·mL^-1.The slight cyclohexanone and antioxidant 1076 were dissolved in ethanol solution (0.577 3 μg·mL^-1, 0.1201μg·mL^-1). Conclusion: The method is sensitive and good stability, which can be used for the study on the dissolution of MDI, antioxidant 1076 and cyclohexanone from disposable TPU infusion device.The dissolved matter of cyclohexanone and antioxidant 1076 from disposable TPU infusion device was slight.