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目的:建立测定一次性使用静脉营养输液器中增塑剂邻苯二甲酸二(2-乙基己基)酯(DEHP)溶出量的方法。方法:采用气相色谱-质谱联用(GC-MS)法,以邻苯二甲酸二丁酯为内标,使用一次性使用静脉营养输液器制备营养液,测定室温放置和模拟临床输液24 h后营养液中DEHP的溶出量。采用Rtx-5 MS色谱柱;进样口温度:300℃;载气:氦气;程序升温模式:起始温度200℃,15℃/min升温至280℃,维持5 min;EI离子源,离子源温度:250℃,接口温度:280℃;采集模式:选择离子监测模式(SIM):质荷比(m/z)149。结果:DEHP检测质量浓度的线性范围为0.2~30μg/m(lr=0.999 8),检测限为0.01μg/ml,定量限为0.04μg/ml,平均回收率为102.4%,RSD为4.23%(n=3),精密度试验RSD为2.7%(n=5)。室温放置24 h营养液中DEHP溶出量为0.547~17.400 mg,模拟临床输液24 h后营养液中DEHP溶出量为8.779~10.620 mg,均小于成人的耐受摄入量(30 mg)。结论:本法简单、快速、准确,可用于一次性使用静脉营养输液器中DEHP溶出量的测定。
Objective: To establish a method for determining the amount of di-2-ethylhexyl phthalate (DEHP) which is a plasticizer in a disposable intravenous infusion set. Methods: Gas chromatography-mass spectrometry (GC-MS) method was used with dibutyl phthalate as internal standard to prepare nutrient solution using single-use intravenous nutrition infusion. After 24 h of storage at room temperature and simulated clinical infusion Dissolution of DEHP in nutrient solution. Using a Rtx-5 MS column; inlet temperature: 300 ° C; carrier gas: helium; temperature programmed mode: initial temperature of 200 ° C, ramp of 15 ° C / min to 280 ° C for 5 min; EI ion source, Source temperature: 250 ℃, interface temperature: 280 ℃; Acquisition mode: Selected ion monitoring mode (SIM): mass-to-charge ratio (m / z) 149. Results: The linear range of DEHP was 0.2 ~ 30μg / m (lr = 0.999 8), the limit of detection was 0.01μg / ml, the limit of quantification was 0.04μg / ml, the average recovery was 102.4% and the RSD was 4.23% n = 3). The RSD of precision test was 2.7% (n = 5). The DEHP dissolution rate was 0.547 ~ 17.400 mg after 24 h of incubation at room temperature. The DEHP dissolution rate of the nutrient solution was 8.779 ~ 10.620 mg after 24 h of simulated clinical infusion, both of which were less than the tolerable adult intake (30 mg). Conclusion: This method is simple, rapid and accurate and can be used to determine the amount of DEHP dissolution in a single-use intravenous infusion set.