無発熱性医薬品の製造に関する研究 (第1報)

通常の精製手段によるTBP反応陽性物質の除去について

抄録

Removal of pyrogen from parenteral solutions was experimentally examined by the ordinary purification method on the degree of pyrogen removal. In this case, the coloration tests was made with TBP reagent which is said to indicate proportional relationship between pyrogen and febrifuge in rabbits. Market product of glucose injection, having positive TBP reaction was recrystallized, treated with various absorbents, oxidative agents, or reducive agents. Fungal culture filtrate, containing pyrogen, was also treated with anion and cation exchange resins and conc. hydrochloric acid. Degree of coloration with TBP reagent was examined on each sample before and after treatments. Experimental results have shown that recrystallization and treatment with oxidation agent were able to decrease substance that gave positive TBP reaction (pyrogen), but not to make it entirely negative. Treatment with ion exchange resins and reductive treatment were found to be practically ineffective.