医用注射器具中DEHP增塑剂溶出量测定  

Determination of Plasticizer DEHP Released from Medical Injection Equipment

作　　者：郑建[1] 王敏珠[1] 王安燕[1] 徐萍华[1] 韩银[1] 文燕[1] 张莉[1] 

机构地区：[1]国家食品药品监督管理局杭州医疗器械质量监督检验中心,杭州市310009

出　　处：《中国医疗器械杂志》2015年第6期451-453,共3页Chinese Journal of Medical Instrumentation

基　　金：浙江省科技厅计划项目(2015F30009)

摘　　要：建立气相色谱-串联质谱（GC-MS/MS）测定医用注射器具医疗器械产品中DEHP溶出量分析方法,探讨样品前处理对测定的影响和评价。通过分析确认,模拟临床使用条件,在37 oC条件下平衡浸提,浸提液经氯仿萃取,萃取液进行气相色谱-串联质谱分析。该方法简便快速,方法检出限低,定性定量准确。定量下限（S/N=5）为0.075 mg/m L,平均加标回收率为92%-98%,相对标准偏差为1.01%-1.61%。此方法样品前处理简单、干扰少、重现性好、分离效率高,可做为医用注射器具医疗器械产品中DEHP溶出量的质量控制的方法之一。To established an effective GC-MS /MS method for the contents determination of the residual DEHP in injection equipment, and investigate the effect of the pretreatment on the measurement. To simulate the clinical conditions of use, under the condition of 37oC balance extraction, extract liquor by chloroform extraction, then the extract folowed by analysis of GC-MS /MS. The method was simple, rapid, sensitive and accurate. The limits of quantitation（ LOQ, S/N = 5） of cyclohexanone was 0.075mg/mL, The spiked average recoveries ranged from 92% to 98%.The relative standard deviations（ RSDs） of the method ranged from 1.01% to 1.61%, The method was simple, fast,sensitive and accurate,and may serve as a mass control method for residual DEHP in injection equipment.

关 键 词：注射器 气相色谱-质谱法 DEHP 塑化剂 

分 类 号：X132[环境科学与工程—环境科学]