顶空气相色谱法测定一次性使用输液器中粘合剂的迁移量

Determination of the migration of adhesives from disposal infusion sets by headspace gas chromatography

采用顶空气相色谱法对一次性使用输液器在药物输注过程中粘合剂丙烯酸甲酯、四氢呋喃及环己酮的迁移量进行了研究。选取了4种代表性的临床药物,模拟临床使用条件,经输液器输注后,对浸提液进行分析。采用DB-624型(30 m×0.25 mm,1.40μm)毛细管柱,氢火焰离子化检测器,程序升温条件为40℃保持5 min,然后以10℃/min升至100℃,再以20℃/min升至240℃并保持2 min。结果表明,丙烯酸甲酯、四氢呋喃及环己酮的质量浓度分别在0.17~3.57、0.077~3.09、0.13~5.50μg/mL范围内与各自的色谱峰面积线性良好,相关系数大于0.998,检出限为0.031~0.11μg/mL。样品加标回收率为72.52%~119.67%,测定结果的相对标准偏差为0.10%~5.46%(n=6)。该方法适用于一次性使用输液器药物输注过程中3种粘合剂迁移量的同时测定。

The migration of adhesives including methyl acrylate,tetrahydrofuran and cyclohexanone from disposal infusion sets in the process of drug infusion was determined by headspace gas chromatography.Four representative clinical drugs were selected,and the extraction solutions prepared by simulating clinical use were analyzed on a DB-624(30 m×0.25 mm,1.40μm)with flame ionization detector(FID).Temperature programming was used,the initial oven temperature was 40℃,maintained for 5 min,and raised to 100℃at 10℃/min,and then raised to 240℃at 20℃/min and maintained for 2 min.The results showed that the linearity of methyl acrylate,tetrahydrofuran and cyclohexanone was good in the range of 0.17-3.57,0.077-3.09,0.13-5.50μg/mL with their respective chromatographic peak areas,the linear correlation coefficients were more than 0.998,respectively.The detection limits of the 3 adhesives were 0.031-0.11μg/mL with relative standard deviation of 0.10%-5.46%(n=6)and recovery rate of standard addition of 72.52%-119.67%.The method is suitable for simultaneous monitoring of 3 adhesives from disposal infusion sets during the process of drug infusion.