国产丁咯地尔片的药物动力学和生物利用度

STUDY ON THE PHARMACOKINETICS AND BIOAVAILABILITY OF DOMESTIC BUFLOMEDIL TABLEIS IN HEALTHY VOLUNTEERS

目的 :以进口丁咯地尔片为对照 ,考察国产丁咯地尔片的药物动力学和相对生物利用度。方法 :8名健康志愿者随机交叉单剂量口服两种片剂各 30 0mg ,采用反相离子对HPLC法测定血药浓度。结果 :经 3P87程序处理 ,国产丁咯地尔片的体内过程符合线性二房室模型 ,Tmax为 (1 38± 0 2 3)h ,Cmax为 (1 2 4± 0 2 5 ) μg/ml,t1/ 2 β为(4 0 2± 0 98)h ,AUC0～t为 (6 97± 1 2 3) (μg·h) /ml,相对生物利用度Fr为 (96 83± 13 73) %。 结论

OBJECTIVE: To study the pharmacokinetics and relative bioavialability of domestic buflomedil METHODS: The randomized, crossover study was conducted in 8 healthy volunteers After receiving a single dose of domestic buflomedil, the serum drug concentrations were determined by reversed phase ionpair HPLC RESULTS: The pharmacokinetic parameters of buflomedil were T max =(1 38±0 23)h,C max =(1 24±0 25)μg/ml,t 1/2 =(4 02±0 98)h,AUC 0～t =(6 97±1 23) (μg·h)/ml The relative bioavailability was (96 83±13 73)% using a imported tablets as reference CONCLUSION: The results showed that the two tablets were bioequivalant