阿酚咖片中阿司匹林的相对生物利用度研究

Study on Relative Bioavailability of Aspirin in Afenca Tablet

对阿酚咖片中的阿司匹林进行相对生物利用度研究。采用反相高效液相色谱法测定 2 4名健康志愿受试者单剂量口服阿酚咖片供试制剂与参比制剂后 ,阿酚咖片中阿司匹林体内活性代谢物水杨酸的血药浓度的变化。用 3P97药动学程序处理试验数据 ,并对试验结果进行方差分析和双单侧 t检验。水杨酸的相对生物利用度为 :10 5 .36 %± 14 .15 % ;两种制剂水杨酸的药时曲线下面积 (AUC0→ T)分别为 :10 3.10± 11.92 μg· h/ ml与 98.4 5±13.4 9μg· h/ ml;达峰时间 (tmax)分别为 :1.5± 0 .5 h与 1.5± 0 .5 h;峰浓度 (Cmax)分别是 :19.31± 2 .4 7μg/ ml与18.95± 2 .4 9μg/ ml。两种制剂中的水杨酸 AU C0→∞ 、AUC0→ T、Tmax及 Cmax经双单侧 t检验进行生物等效性评价 ,表明以制剂中阿司匹林活性代谢产物水杨酸为指标 ,两种制剂生物等效 (t1 ≥ t1 - 0 .0 5( 2 2 ) ,t2 ≥ t1 - 0 .0 5( 2 2 ) )

Salicylic acid is a kind of active metabolite of aspirin in vivo. In this study, its concentration in plasma was detected by RP HPLC after twenty four healthy male volunteers were given each a single dose of oral Afenca test and reference preparations .The experiment data were calculated with 3P97 program.The results were analyzed by ANOVA and two and one sided t tests.The relative bioavailability of salicylic acid was 105 36%±14 15%; AUC 0 T of salicylic acid of test and reference preparations were 103 10±11 92 μg·h/ml and 98 45±13 49 μg·h/ml respectively; T max were 1 5±0 5 h and 1 5±0 5 h;C max were 19 31±2 47 μg/ml and 18.95±2.49 μg/ml.Bioequivalent evaluation of two preparations by analyzing with two and one sided t tests showed that the two preparations were bioequivalent on the basis of salicylic acid (t 1≥t 1 0.05(22) , t 2≥t 1 0.05(22) ).