文章摘要

文章信息/Info

作者:: 李永贵1; 2; 尹弢1; 2; 张锡霞1; 2; 徐伟娜1; 2; 王晶1; 2△; 1.山东省药学科学院山东省化学药物重点实验室，济南250101；2.山东省药学科学院山东省医用高分子材料重点实验室，济南250101

Author(s):: LI Yonggui1; 2; YIN Tao1; 2; ZHANG Xixia1; 2; Xu Weina1; 2; WANG Jing1; 2; 1.Shandong Academy of Pharmaceutical Sciences，Shandong Provincial Key Laboratory of Chemical Drug，Jinan 250101，China；2.Shandong Academy of Pharmaceutical Science，Shandong Provincial Key Laboratory of Biomedical Polymers，Jinan 250101

Keywords:: Cyclohexanone; Disposable infusion sets; Gas chromatography; Migration; Safety evaluation

摘要:: 本研究建立了测定环己酮的气相方法，利用浸提及模拟滴注法对输液器中的环己酮进行迁移研究。色谱柱为GsBP-5毛细管柱（30 m×0.32 mm×0.25 μm），载气为氮气，进样口温度200℃，氢火焰离子化器（FID），检测器温度250℃，柱温90℃，分流比5∶〖KG-*2/3〗1，进样量1.0 μL。结果显示环己酮浓度在0.98～97.91 μg/mL范围内线性关系良好（r=0.9999），平均回收率为99.80%，RSD为0.87%。该方法简单、快速、准确，可用于一次性使用输液器中环己酮的迁移测定。

Abstract:: A gas chromatography method was established for determination of cyclohexanone. The migration solution of cyclohexanone was obtained by leaching and simulated drip.GsBP-5 capillary column (30m ×0.32mm×0.25μm) was used，the carrier gas was nitrogen，the injection port temperature was 200℃，and the temperature of FID was 250℃，the oven temperature was 90℃．The split ratio was 5:1 and the sample volume was set at 1.0μL． The results showed that the concentration of cyclohexanone was good linear in the range of 0.98～97.91μg/mL（r=0.9999）.The average recovery of chromatography was 99.80%，and the relative standard deviation was 0.87 %． The method is simple，rapid and accurate for the determination of cyclohexanone in disposable infusion sets.