消化酵素カプセル剤の経時安定性

概要

論文の詳細を見る
Six brands of multiple digestive enzyme capsules were tested for their stability of weight, disintegration of capsules, enzyme activity and dissolution in the solutions of pH 6.5, 5.0 3.0, and the 2nd fluid of J.P.IX after storage in press-through pack (PTP) at room temperature for one year. After storage, properties of some preparations were degraded. When stored in simple packs prepared by the manufacturers, the preparations maintained better stability than the storage in PTP, though slightly degraded in quality. AC and PT were tested for the change with time in their activity and dissolution through the storage at 30°, 80% RH, and at 35°, 80% RH in and out of PTP. At 30°, their enzyme activity seemed to be stable for 4 weeks, though the color and odor of the content of capsules increased gradually. Acid resistance of enteric coating of PT, which was initially excellent, was gradually lowered. After storage for 6 weeks at 35°, AC and PT changed solubility of capsules, and their odor became practically intolerable.
日本医療薬学会の論文
1980-08-20