輸液セットからのシクロスポリン注射液へのDEHPの溶出

概要

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We investigated the leaching of diethylhexyl phthalate (DEHP, a plasticizer of polyvinyl chloride) from a polyvinyl chloride container or an administration set into intravenous cyclosporine solutions. The concentration of DEHP was measured by high-performance liquid chromatography. A linear relation was found between the amount of DEHP dissolved from the administration set into the aqueous solution and the concentration of polyoxyethylated castor oil within the range of 2.5〜12.5mg/ml. The amount of DEHP dissolved from the polyvinyl chloride bag into solutions increased with time, and after 24 hours at initial cyclosporine concentration of 1.0mg/ml, 76.7μg/ml of DEHP was found in the solution. When the cyclosporine solution was passed through the administration set with 100cm in length at a flow rate 0.58ml/min and with the initial cyclosporine concentration of 500μg/ml, the concentration of DEHP in the solution was increased to as much as about 5.8μg/ml in 30 min, and the same level continued till 180min.
日本医療薬学会の論文
1992-10-20