粉末薬剤の安定性と保存湿度の関係

概要

論文の詳細を見る
Recently, we have found 3 different values, θ, RHs and RHs', to represent hygroscopicity of pharmaceutical preparations in powder or granule, and recommended that those preparations should be stored under relative humidity (RH) lower than RHs to protect them from environmental water. The effect of storage on degradation of active ingredients in dry syrup (DS) preparations was examined in the present study. The same DS preparations as the previous work, with and without addition of sulpyrine powder, were stored on 7 grades of RH at 30°. Each active ingredient was determined by HPLC after storage for 0, 3, 7 and 14 days. Sulpyrine stimulated degradation of the active ingredient in DS preparations tested except F, because sulpyrine increased moisture absorption of the DS preparations and caused interaction with the active ingredients. When stored at RH lower than RHs, DS preparations except B and C showed the degradation less than 5% for up to 7 days, and those except B, C and D for up to 14 days. It is concluded that powders and/or granules should be stored at RH lower than RHs.
日本医療薬学会の論文
1983-08-20