院内製剤エピネフリン・コハク酸プレドニゾロン混合吸入液の安定性

Abstract

After a mixed solution of epinephrine and prednisolone succinate for inhalation (Nebulizer No.1 solution) was prepared in the hospital and was allocated into 50m1 sterilized bottles, Nebulizer No.1 solution was stored for 4 weeks under the following 3 conditions i.e.at room temperature with room lighting (25±2°C, 500 lux), at room temperature with prevention of room light transmittance (25±2°C, covered with brown light-resistant bag), and in a cool and dark place (5-10°C, covered with brown light-resistant bag). After the storage, the observation of appearances, pH measurement, the measurement of contents and the identification and quantification of decomposed products by high-performance liquid chromatography (HPLC) were performed.In storage at room temperature under room lighting or prevention of room light transmittance, Nebulizer No.1 solution was markedly colored; contents of epinephrine and prednisolone succinate in the mixed solution were decreased; and adrenochrome and prednisolone were detected as decomposed products.In cool and dark storage, there were no changes in appearances, even after storage for 4 weeks, and epinephrine and prednisolone succinate remained by 86% and 92%, respectively.