聚氯乙烯腹膜透析袋中的邻苯二甲酸二(2-乙基)己酯迁移量测定及安全性评价

Migration Determination and Safety Assessment of Di (2-ethylhxyl) Phthalate in Polyvinyl Chloride Peritoneal Dialysis Bags

建立腹膜透析液中邻苯二甲酸二(2-乙基)己酯(DEHP)迁移量的测定方法和安全性评价方法。采用气相色谱-质谱联用(GC-MS)法,以DEHP-D4为内标,采用HP-5MS色谱柱,程序升温模式,质谱采用EI离子源,定量采用选择离子监测模式(SIM)。结果表明,DEHP在0.03~2.0μg/mL时,线性范围良好,检测限为0.01μg/mL;回收率在85%~96%之间,精密度试验的RSD在2.8%~7.1%。该方法精密度、回收率良好,为不同药品中DEHP迁移量测定提供了一个科学的方法。

Objective to establish a method for the migration determination and safety assessment of Di(2-ethylhxyl) phthalate(DEHP) in peritoneal dialysis.METHODS GC-MS analysis was performed,using DEHP-D4 as internal standard.The determination was performed on HP-5MS column,with programmed column temperature.The EI source was used for MS detector and SIM model was used in quantification.RESULTS It was linear for DEHP in the range of 0.03~2.0 μg/mL;the limit of detection was 0.01 μg/mL.The recovery was in the range of 85%~96%,RSD of precision test was in the range of 2.8%~7.1%.CONCLUSION The method has satisfactory precision and recovery.It provides a scientific method for the migration determination in varies pharmaceutical products.