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用~3H-苯妥英(~3H-DPH)放射免疫药盒为分析手段,研究了8个志愿者对DPH-Na的三种不同制剂——胶囊剂(A)、普通压制片(B)和糖衣片(C)的生物利用度及基本药物动力学参数。比较了经微处理机计算的生物利用度参数(C_m、t_m、AUC),未发现有显著差异;故认为所研究的三种制剂是生物等效性的,其中以B的生产过程最为简单,在临床上可互相替换使用。由本实验所得我国人体内DPH-Na的生物半衰期为9.6±1.3h,与:日本人的9.1～11.2h十分接近,而在白种人与黑种人中则要长得多,分别为18.5及26.5h;这对合理制定符合我国人的DPH给药方案是有所裨益的。
Eight volunteers studied the effects of three different formulations of DPH-Na - capsule (A), conventional compressed tablet (B) and sugar-coated Bioavailability of tablets (C) and basic pharmacokinetic parameters. The bioavailability parameters (C_m, t_m, AUC) calculated by the microprocessor were compared and no significant differences were found. Therefore, the three preparations studied were bioequivalent, of which the production process of B was the simplest, In clinical use can replace each other. The biological half-life of DPH-Na in human body in our country is 9.6 ± 1.3h, which is very close to that of Japanese: 9.1 ~ 11.2h, while it is much longer in Caucasian and blacks (18.5 and 26.5h; This is reasonable to formulate in line with our DPH dosing program is of some benefit.