脂肪乳剤滴下時における各種輸液セットからの可塑剤の溶出

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The use of Tris (2-ethylhexyl) trimellitate (TOTM) as an alternative to di (2-ethylhexyl) phthalate (DEHP) as a plasticizer in polyvinyl chloride (PVC) medical devices is steadily increasing. Four types of administration sets are available : generaltype sets made of PVC using DEHP (DEHP-PVC) or TOTM (TOTM-PVC) as a plasticizer, pump-type sets made of DEHP-PVC, and those made of polybutadiene (PB). Since the elution of plasticizer from administration sets when specific drugs are passed though them is a matter of concern, in the present study, we compared the amounts of plasticizer eluted from these 4 types of administration sets after passing fat emulsion through them, for different drip rates. The concentrations of plasticizer eluted were lowest for the TOTM-PVC administration set, followed in ascending order by the general-type DEHP-PVC and pump-type DEHP-PVC sets. Neither DEHP nor TOTM was detected for the PB set. For the general-type administration set, the maximum concentrations of TOTM and DEHP eluted were obtained with a drip rate of 10 mL/hr, which were 0.38μg/mL for TOTM and 10.32μg/mL for DEHP, respectively. At a drip rate of 80 mL/hr, the maximum concentration of DEHP was 0.97μg/mL but TOTM was not detected. These results indicate that TOTM is less easily eluted than DEHP and that TOTM-PVC is an excellent material for administration sets in view of its low elution characteristics, though care needs to be taken with regard to drug adsorption.
2005-04-10

脂肪乳剤滴下時における各種輸液セットからの可塑剤の溶出

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