ニフェジピン軟カプセル剤におよぼす湿度の影響

概要

論文の詳細を見る
Effects of humidity on the stability of nifedipine soft capsules were studied. Three commercial products were subjected to the test. Humidity conditions were set to be 55% and 80% of relative humidity and light resistant desiccators, where the samples were kept for 3 months under the same conditions as those previously reported^<1)>. Changes of amount of both the contents of nifedipine soft capsules and nifedipine (Np) in the capsule shells were followed by high-performance liquid chromatography. Samples kept with PTP were stable, showing only slight decrease of the contents under both conditions. However, in the samples removed from PTP, it was observed that the amount of Np in the capsule shells increased with the decrease of the content and that Np oozed out the surface of the capsules at 80% of relative humidity. Differences of the amounts of Np which migrated from the content to the capsule shells were observed among the three products. It was also discussed that the migration was highly affected not only by the external environmental factors such as humidity but also by the factors of capsule preparations.
日本医療薬学会の論文
1986-08-20