含糖酸化鉄製剤の希釈時における安定性に関する検討

抄録

Saccharated ferric oxide is an iron preparation for intravenous injection obtained by colloidal particles of ferric hydroxide with sucrose. Although it is necessary to dilute saccharated ferric oxide with a 10-20％ glucose injection solution according to the product labeling, it is often diluted with 5％ glucose injection solution and/or saline in clinical practice. In the present study, we evaluated the stability of saccharated ferric oxide in various diluted solutions in terms of the abundance of free iron ions. The abundance ratio of free iron ions significantly increased with pH elevation of the diluted solution. Moreover, a marked decrease in the abundance ratio of free iron ions was observed in the sodium chloride solution exceeding the physiological concentration (0.9％). Furthermore, a statistical decrease in the abundance ratio of free iron ions was confirmed in the glucose solution compared to saline, and the degree of liberation of free iron ions in 5％ glucose solution was the lowest among various concentrations of glucose solution. These results indicate the possibility that saccharated ferric oxide can be diluted by 5％ glucose injection solution with minimal effects on its stability, although its dilution according to the product labeling is basically important.