バルプロ酸ナトリウム製剤シロップ剤と細粒剤のバイオアベイラビリティ

概要

論文の詳細を見る
Bioavailabilities of commercially available VPA-Na in syrup (Depakene^<[○!R]> syrup, VPA-syr) and in fine granules (Hyserenin^<[○!R]> fine granules, VPA-FG) were compared. Following oral administration of 15mg/kg of VPA-syr in single dose to 7 healthy male subjects at the age of 18 to 26, serum concentrations were determined by gas chromatography. After 7 days. VPA-FG was administered in the same dosage to the same subjects and the serum concentrations were measured. The results were analyzed in one-compartment open model. Mean ± S. D. of the maximum serum concentration level of VPA and the time required to achieve the level following administration of VPA-syr and VPA-FG were 31.9±20.3 min, 105.9±7.4 /μg/ml; and 24.8±3.8 min, 102.1±10.7μg/ml, respectively, while the areas under the curve of the serum concentrations (AUC_0→_∞) were 1602.2±219.8μg・hr/ml for the former and 1554.6±192.1μg・hr/ml for the latter. These results show that there is no statistically significant difference at the 5% significance level, and these drugs are equivalent preparations.
日本医療薬学会の論文
1983-06-20