PVC输液器中环己酮和增塑剂ATBC的迁移性质研究  

Study on the Migration of Cyclohexanone and Plasticizer ATBC in PVC Infusion Set

作　　者：王悦[1] 金祥飞[1] 周新宇[1] 陈建秋[2] 田雨橙 沈卫阳[1] 

机构地区：[1]中国药科大学理学院,药物质量与安全预警教育部重点实验室,江苏南京210009 [2]中国药科大学工学院,江苏南京210009

出　　处：《塑料工业》2016年第7期84-87,共4页China Plastics Industry

摘　　要：建立聚氯乙烯（PVC）输液器中增塑剂乙酰柠檬酸三丁酯（ATBC）和黏合剂环己酮迁移量的气相色谱检测方法，并对输液器中ATBC和环己酮的迁移情况进行分析，考察其迁移性质。选择5种注射液，模拟临床使用条件，经聚氯乙烯（PVC）输液器输出后用正己烷萃取，萃取液进行气相色谱分析。结果表明，ATBC和环己酮分别在0．1006～88．05、0．01014—8．115斗∥mL浓度范围内线性关系良好（r=0．9999），各输液平均加标回收率均在95％～104％之间，相对标准偏差均小于5．9％；实验温度越高，ATBC和环己酮的迁移量越大，ATBC迁移至脂溶性输液中的量大于水溶性输液。该方法快速简便、重复性好，可用于PVC输液器中ATBC和环己酮的迁移量的检测。Thia paper established a gas phase chromatography （GC） method for the determination of acetyl tributyl citrate （ ATBC ） and cyclohexanone in an infusion set and carried out the investigation of ATBC and cyclohexanone migration. Based on the clinical conditions, five injections were selected and flowed through PVC infusion sets, ATBC and cyclohexanone were determinated followed by the n-hexane extraction. The results show that calibration curves of ATBC and cyclohexanone are both linear over the ranges of 0. 100 6 88.05 μg/mL and 0. 010 14 - 8.115 μg/mL （ r = 0. 999 9 ）, respectively. The average recoveries are both between 95% and 104% （relative standard deviation less than 5%）. ATBC and cyclohexanone migration amounts become larger with the increase of test temperature, and the migration amounts of ATBC to fat soluble injections are greater than that to water soluble injections. The method is simple, fast and reproducible, which is suitable for the migration test of ATBC and cyclohexanone in infusion set.

关 键 词：输液器 气相色谱 乙酰柠檬酸三丁酯 环己酮 迁移 

分 类 号：TQ325.3[化学工程—合成树脂塑料工业]