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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 :两种制剂具有生物学等效性
OBJECTIVE: To compare the pharmacokinetics and relative bioavailability of domestic buflomil tablets by importing buflomedil tablets. Methods: Eight healthy volunteers were randomized to a single crossover dose of two tablets each 30 0mg, using reversed-phase ion-exchange HPLC determination of plasma concentration. Results: After 3P87 treatment, the in vivo process of domestic buflomedil tablets accorded with the linear two-compartment model with Tmax of (1 38 ± 0 2 3) h and Cmax of (1 24 ± 0 25) μg / ml, t1 / 2 β was (4 0 2 ± 0 98) h, AUC0 ~ t was (6 97 ± 1 2 3) (μg · h) / ml, and relative bioavailability Fr was (96 83 ± 13 73)%. Conclusion: The two preparations are bioequivalent