聚氨酯输液器中7种异氰酸酯成分的提取与2种抗氧剂的溶出研究

Study on Extractable Materials of Seven Isocyanates and Dissolution of Two Antioxidants from TPU Infusion Device

文章模拟银杏二萜内酯葡胺注射液(GDLI)的临床使用情况,建立7种异氰酸酯类成分的提取与2种抗氧剂的溶出检查方法。异氰酸酯类成分检测采用高效液相色谱(HPLC)柱前衍生法,衍生试剂为9-N-甲氨甲基蒽,以Kromasil C_(18)为色谱柱,以乙腈-3%三乙胺溶液为流动相系统。抗氧剂1010与1076检测采用HPLC法,Kromasil C_(18)色谱柱,以甲醇-水(90∶10)为流动相。结果表明:7个异氰酸酯类成分在4.1~96.8 ng/mL范围内线性关系良好,平均回收率在78.0%~106.9%之间,检出限在0.005~0.015 ng/mL之间,定量限在0.015~0.050 ng/mL之间。抗氧剂1010与1076分别在0.1520~118.6000μg/mL、0.3920~122.6000μg/mL范围内线性关系良好,平均回收率分别为92.0%、101.0%,检测限分别为0.456 ng/mL、1.570 ng/mL,定量限分别为1.52 ng/mL、3.92 ng/mL。实验建立的方法灵敏度高、重复性较好,适合对聚氨酯输液器中异氰酸酯类成分的提取和抗氧剂的溶出研究。

To simulate the clinical application of ginkgo diterpene lactone meglumine injection(GDLI),a method for the extraction of seven isocyanate components and the dissolution test of two antioxidants was established.The detection of isocyanates was performed by high performance liquid chromatography(HPLC)with pre-column derivatization.The derivatization reagent was 9-N-methylaminomethylanthracene.The Kromasil C_(18) column was used with acetonitrile-3%triethylamine solution as the mobile phase system.Antioxidants 1010 and 1076 were detected by HPLC with Kromasil C_(18) chromatographic column and methanol-water(90∶10)as mobile phase.The results show that the seven isocyanate components has a good linear relationship in the range of 4.1~96.8 ng/mL.The average recovery rate is between 78.0%and 106.9%.The detection limit is between 0.005 and 0.015 ng/mL,and the limit of quantitation is between 0.015 and 0.050 ng/mL.The linear ranges of antioxidant 1010 and 1076 are 0.1520~118.6000μg/mL and 0.3920~122.6000μg/mL,respectively.The average recoveries are 92.0%and 101.0%,respectively.The limits of detection are 0.456 ng/mL and 1.570 ng/mL,respectively.The limits of quantitation are 1.52 ng/mL and 3.92 ng/mL,respectively.The method established in the experiment has high sensitivity and good repeatability,and is suitable for the extraction of isocyanate components and the dissolution of antioxidants in thermal polyurethane(TPU)infusion device.