ニホンジン ガン カンジャ ニ オイテ UGT1A1*6 ワ エンサン イリノテカン ニ ヨル ジュウトクナ コウチュウキュウ ゲンショウショウ ノ ヨソク インシ ト ナル

京都大学0048新制・論文博士博士(医学)乙第12318号論医博第1975号新制||医||975(附属図書館)UT51-2009-D533(主査)教授 川上 浩司, 教授 内山 卓, 教授 藤田 潤学位規則第4条第2項該当Doctor of Medical ScienceKyoto UniversityDA

Pharmaceutical stability of colloidal saccharated iron oxide injection in normal saline

Abstract Background Colloidal saccharated iron oxide injection is used for the treatment of iron deficiency anemia in patients with a poor oral intake. Because of the poor stability of the colloid particle, there have been concerns regarding its compatibility with various injections in clinical practice. To assess the stability of colloidal saccharated iron oxide in normal saline as a diluent, pharmaceutical stability analyses were conducted using various concentrations of glucose and sodium chloride (NaCl). Methods Colloidal saccharated iron oxide injection was diluted in three different diluents (5% glucose solution, normal saline, and 10% NaCl solution), and its appearance, colloid particle diameter, and pH were assessed. Free iron ions, which cause adverse effects, such as nausea and vomiting, were separated from the colloid particle using a dialysis membrane for 24 h, and their concentration was determined. Results No difference in the appearance, colloid diameter, and free iron ion fraction was observed after dilution in 5% glucose solution and normal saline. Conversely, an increased colloid aggregation and iron ion release were observed after dilution in 10% NaCl solution. Although iron colloid is unstable in acidic conditions (pH 4.0–6.0), normal diluents such as 5% glucose and normal saline did not cause colloid destabilization by pH change (pH > 8.0). Conclusion Normal saline may be used as a diluent of colloidal saccharated iron oxide injection as well as glucose solution, which is recommended by the pharmaceutical company. Therefore, normal saline can be used as a diluent of colloidal saccharated iron oxide injection in patients with an underlying disease, such as diabetes mellitus, who are difficult to use glucose solution as a diluent