テオフィリン持続性製剤の製剤試験および血中濃度

概要

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Plasma theophylline concentration of a slow-release theophylline preparation (SRT : Theona P) was measured by high-pressure liquid chromatography. SRT was administered to 6 healthy adults orally in dose of 100 mg. Dissolution test of SRT by the rotating basket method made in accordance with U.S.P.XVIII revealed that the drug tended to dissolve slowly, dissolution rate being about 50% 6 hours after initiation of the experiment. The experiment also demonstrated that plasma concentration of theophylline reached peak about 5 hours after oral administration of SRT on the average, and about 2 hours after use of Aminophylline Tablet (immediate-release preparation). Average maximal plasma theophylline level was 1.32μg/ml for SRT as compared with 1.92μg/ml for Aminophylline. In clinical trial, the plasma concentration of theophylline was not maintained at 10μg/ml after oral administration of SRT and Aminophylline Tablet in dose of 100mg 4 times a day, respectively. The 10-μg/ml level was maintained when SRT single dose was increased to 200 mg.
日本医療薬学会の論文
1981-02-20