CAJ | 학술논문

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0.075mg/mL，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。
건립기상색보-천련질보(GC-MS/MS)측정의용주사기구의료기계산품중DEHP용출량분석방법，탐토양품전처리대측정적영향화평개。통과분석학인，모의림상사용조건，재37 oC조건하평형침제，침제액경록방췌취，췌취액진행기상색보-천련질보분석。해방법간편쾌속，방법검출한저，정성정량준학。정량하한(S/N =5)위0.075mg/mL，평균가표회수솔위92%～98%，상대표준편차위1.01%～1.61%。차방법양품전처리간단、간우소、중현성호、분리효솔고,가주위의용주사기구의료기계산품중DEHP용출량적질량공제적방법지일。
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.