イオパミドール配合エタノールアミンオレート注射剤の調製法

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The preparation of ethanolamine oleate injections containing 50% of iopamiron 300(EO-IP300) in sclerosing treatment(endoscopic embolization) of esophageal varix was tried by 4 kinds of representative methods. Because of difficulty in mixing, the whitening solution of EO-IP300 was often produced by method B, C and D, However, method A always gave the clear solution of that. The preparation of EO-IP300 using differently graded or degraded reagents(oleic acids, ethanolamines and benzyl alcohols) was tried by method A. No abnormality was observed in appearance of all the samples. Then, the samples of EO-IP300 contained in an ampule with air or N_2 were sterilized and were stored for 4 weeks under different conditions. The changes in appearance, pH, specific gravity, viscosity, osmotic pressure, and contents of iopamidol, oleic acid and benzyl alcohol, and the concentration of iodides (contaminants) were examined at intervals. After sterilization, no change was observed in each test item except increase of the content of iodides in all sterilized samples of EO-IP300. Almost no change was observed in each test item during 4 weeks in a dark place below room temperature, nor was significant difference seen between the samples contained with air and N_2, These results suggest that the reagent grade, the replaced gas, and sterilization condition are not significant to obtain the clear solution of EO-IP300 but the preparation method is, and that EO-IP300 is stable for at least 4 weeks in a dark place below room temperature.
日本医療薬学会の論文
1992-02-20

イオパミドール配合エタノールアミンオレート注射剤の調製法

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