PVC医疗器械中非邻苯二甲酸酯类增塑剂DINCH的含量和迁移量的检测方法研究

Determination of content and migration of non-phthalate plasticizers DINCH in PVC medical devices

目的：采用气相色谱质谱联用法测定聚氯乙烯（PVC）医疗器械中非邻苯二甲酸酯类增塑剂环己烷1,2-二甲酸二异壬基酯（diisononyl cyclohexane-1,2-dicarboxylate,DINCH）的含量和迁移量。方法：分别用乙醚加热回流法提取PVC医疗器械中DINCH,以脂肪乳为浸提液评价DINCH的迁移量,并建立GCMS方法检测测试液中DINCH的含量。结果：该方法线性范围为50～800μg·mL-1,r=0.9999,在提取试验和迁移试验中,DINCH的回收率为81.7%～101.5%,RSD均小于5.0%。结论：本文建立的方法可用于PVC医疗器械中DINCH含量和迁移量的评价。

Objective： Determination of the content and migration of non- phthalate plasticizers diisononyl cyclohexane- 1,2- dicarboxylate（ DINCH） in PVC medical devices by GC- MS. Methods： The content of DINCH was detected by ether reflux and the migration of DINCH was evaluated using fat emulsion as extracts. GCMS analysis method was developed to detect DINCH. The DB- 5MS capillary column（ 30 m × 0. 25 mm × 0. 25 μm） was adopted with the vaporization temperature of 290 ℃. Heating program： the initial temperature was 200 ℃,kept for 2min,and then increased at a rate of 10 ℃ ·min- 1to 300 ℃,and finally the temperature was maintained for 2min. The electron impact（ EI） ion source was selected and the temperature of ion source was 200 ℃. Results： The results showed that the linear range was 50- 800 μg·mL- 1,r =0.9999. The recovery rate of DINCH was between81. 7% and 101. 5%,and RSD was less than 5. 0% in both the extraction and migration experiments. Conclusion：The method established could be used for the evaluation of the content and migration of DINCH in PVC medical devices.