气相色谱-质谱法测定一次性使用高压造影注射器及附件中环己酮和乙酰柠檬酸三丁酯的迁移量  

Determination of the migration of cyclohexanone and acetyl tributyl citrate from disposal syringes and accessories by GC-MS

作　　者：薄晓文 刘爱娟 沈永[1] 孟凯 亓晓庆 BO Xiaowen;LIU Aijuan;SHEN Yong;MENG Kai;QI Xiaoqing(Shandong Quality Inspection Center for Medical Devices,NMPA Key Laboratory of Safety Evaluation for Biomaterials and Medical Devices,Shandong Key Laboratory of Biological Evaluation for Medical Devices,Jinan 250101,China)

机构地区：[1]山东省医疗器械产品质量检验中心,国家药品监督管理局生物材料器械安全性评价重点实验室,山东省医疗器械生物学评价重点实验室,济南250101

出　　处：《化学分析计量》2020年第5期68-71,79,共5页Chemical Analysis And Meterage

摘　　要：建立一次性使用高压造影注射器及附件中粘合剂环己酮和增塑剂乙酰柠檬酸三丁酯迁移量的气相色谱-质谱检测方法。选择两种造影剂,模拟临床使用条件,经高压造影注射器推注后用正己烷萃取,用气相色谱-质谱法对其中的环己酮和乙酰柠檬酸三丁酯进行定量分析。结果表明,环己酮和乙酰柠檬酸三丁酯的质量浓度分别在0.151~0.906μg/mL和0.0475~0.4750μg/mL范围内线性关系良好(r≥0.9994),样品测定结果的相对标准偏差为1.0%~3.6%(n=6),加标回收率分别为92.3%~103.9%,67.6%~89.7%。该方法简单、快速、准确,可用于高压造影注射器中环己酮和乙酰柠檬酸三丁酯迁移量的测定。A gas chromatography-mass spectrometry(GC-MS)method was developed for the determination of cyclohexanone and acetyl tributyl citrate migration from disposal syringes and accessories.Two contrast agents were selected and infused through disposal syringes and accessories by simulating clinical use,and then extracted with n-hexane.GC-MS method was adopted for the quantitative analysis of cyclohexanone and acetyl tributyl citrate.The results showed that the linearity of cyclohexanone and acetyl tributyl citrate was good respectively in the range of 0.151-0.906μg/mL and 0.0475-0.4750μg/mL with the corelation coefficient not less than 0.9994.The relative standard deviations of the detection results were 1.0%-3.6%(n=6),and the recoveries were 92.3%-103.9%and 67.6%-89.7%.The method is simple,rapid,sensitive,reliable and it is suitable for the determination of cyclohexanone and acetyl tributyl citrate released from disposal syringes and accessories.

关 键 词：环己酮 乙酰柠檬酸三丁酯 一次性使用高压造影注射器及附件 气相色谱-质谱 

分 类 号：O657.7[理学—分析化学]