国产硝苯地平控释片的药动学和生物等效性研究

Pharmacokinetics and Bioequivalence of Domestic Nifedipine Controlled Release Tablets

目的研究国产和进口硝苯地平控释片的药物动力学和生物等效性。方法采用双周期自身交叉设计,18名男性健康受试者分别单剂量及多剂量口服30mg国产或进口硝苯地平控释片,RPHPLC法测定硝苯地平血药浓度。结果受试者单剂量口服30mg国产和进口硝苯地平控释片的Cmax分别为(27.5±15.9)ng/mL和(29.9±11.9)ng/mL;Tmax分别为(9.9±6.8)h和(9.5±6.6)h;AUC0→t分别为(686.1±253.3)ng/h·mL和(675.0±262.9)ng/h·mL。国产控释片的相对生物利用度为102.8%±13.3%(n=18)。多剂量服药后两制剂的AUC0→t分别为(686.1±253.3)ng·h·mL和(675.0±262.9)ng/h·mL,国产控释片的相对生物利用度为102.9%±13.8%(n=18)。结论主要药动学参数AUC0→t、Cmax经统计学处理(方差分析和双单侧t检验),结果表明两制剂具生物等效性。

ObjectiveTo investigate the pharmacokinetics and bioequivalence of domestic and imported nifedipine controlled release tablets.Methods According to randomized crossover design, 18 health man volunteers were taken a single oral dose or multiple dosing of 30 mg nifedipine controlled release tablets.Plasma concentration of nifedipine was determinetd by RP-HPLC.ResultsThe pharmacokinetics parameters for the single oral dose of domestic and imported nifedipine controlled release tablet were C max (27.5±15.9)ng/mL and (29.9±11.9)ng/mL;T max (9.9±6.8) h and (9.5±6.6) h, AUC 0→t (686.1±253.3) ng/h·L and (675.0±262.9) ng/h·L.The relative bioavailability for the domestic formulation was 102.8%±13.3%(n=18).For the multiple dosing, the AUC 0→t were (686.1±253.3)ng/h·mL and (675.0±262.9)ng/h·mL, and the relative bioavailability for the domestic formulation was 102.9%±13.8%(n=18).ConclusionThese data showed that the domestic formulation was bioequivalent to imported formulation.