顶空气相色谱法研究一次性输液器中环己酮和2-乙基己醇的迁移  

Migration of Cyclohexanone and 2-Ethyl-1-hexanol in Disposable Infusion Sets Determined by Headspace Gas Chromatography

作　　者：梁波 郑烨 王蓉佳 张芳芳 蔡荣 LIANG Bo;ZHENG Ye;WANG Rongjia;ZHANG Fangfang;CAI Rong(Shanghai Food and Drug Packaging Material Testing Institute,Shanghai 201203)

机构地区：[1]上海市食品药品包装材料测试所,上海201203

出　　处：《中国医药工业杂志》2021年第2期250-253,共4页Chinese Journal of Pharmaceuticals

摘　　要：建立了气相色谱法测定一次性输液器中的环己酮和2-乙基己醇。色谱柱采用HP-INNOWAX柱,载气为氮气,流速为2 ml/min,分流比为10∶1,进样口温度为250℃,FID温度为270℃,内标物为异丁醇。结果显示,环己酮和2-乙基己醇分别在0.2~15和0.02~2.0μg/ml内线性关系良好,检测限分别为0.01和0.02μg/ml。样品检测结果显示,多种输液器中均检出环己酮和2-乙基己醇,且迁移量与滴注时长、药液浓度成正比。本方法准确、稳定、可行性好,可用于考察不同药液的输液器中环己酮和2-乙基己醇的迁移量。A gas chromatography method was established to determine the cyclohexanone and 2-ethyl-1-hexanol in disposable infusion sets.The HP-INNOWAX column was used with nitrogen as the carrier gas.The flow rate was 2 ml/min,the split ratio was 10∶1,the injection port temperature was 250℃,the FID temperature was 270℃,and the internal standard was isobutyl alcohol.The results showed that cyclohexanone and 2-ethyl-1-hexanol were linear in the ranges of 0.2-15 and 0.02-2.0μg/ml,and the detection limits were 0.01 and 0.02μg/ml respectively.The sample test results showed that cyclohexanone and 2-ethyl-1-hexanol were detected in some infusion sets.The migration amount was proportional to the instillation time,and the concentration of liquid medicine.This method was accurate,stable,and feasible,which could be used to investigate the migration of cyclohexanone and 2-ethyl-1-hexanol in infusion sets of different injection solution.

关 键 词：药物迁移 环己酮 2-乙基己醇 一次性输液器 

分 类 号：R917[医药卫生—药物分析学]