国产与进口盐酸非那吡啶片人体生物等效性研究

目的:研究国产与进口盐酸非那吡啶片在人体的药动学过程及国产片的生物利用度,并评价二者是否等效。方法:18名健康男性志愿者随机交叉单剂量口服国产或进口盐酸非那吡啶片200mg后,采用高效液相色谱法测定血药浓度,用3p97软件计算两者的药动学参数,并评价其生物等效性。结果:国产与进口盐酸非那吡啶片的药-时曲线符合口服吸收一室模型,药动学参数分别为:t1/2K(e3.52±2.03)、(3.18±1.85)h,tma(x0.76±0.33)、(0.79±0.43)h,Cma(x76.41±70.15)、(75.49±70.37)ng.mL-1,AUC0～8(159.10±116.32)、(164.65±129.89)ng.h.mL-1,AUC0～∞(237.12±115.06)、(262.69±155.05)ng.h.mL-1。国产盐酸非那吡啶片的相对生物利用度为(96.63±14.05)%,经方差分析、双单侧t检验及1-2α置信区间法统计分析,各药动学参数差异无统计学意义(P>0.05)。结论:国产盐酸非那吡啶片与进口片具有生物等效性。

Bioequivalence of Domestic and Imported Phenazopyridine Hydrochloride Tablets in Healthy Volunteers

OBJECTIVE：To study pharmacokinetics of domestic and imported Phenazopyridine hydrochloride tables and bioavailability of domestic tablets, and to evaluate the bioequivalence of two kinds of tablets. METHODS： A randomized crossover design was performed in 18 healthy male volunteers. They received a single oral dose of domestic or imported tablets 200 mg. Plasma concentration of phenazopyridine hydrochloride was measured by HPLC. The pharmacokinetic parameters were calculated by 3p97 software and relative bioavailability was evaluated. RESULTS： The plasma concentration-time curves of domestic and imported tablets conformed to one-compartment model. Main pharmacokinetic parameters of domestic tablets vs. imported tablets were as follows： t1/2Ke（3.52±2.03） h vs. （3.18±1.85）h; tmax（0.76±0.33） h vs. （0.79±0.43）h; Cmax（76.41±70.15） ng·mL-1 vs. （75.49±70.37） ng·mL-1; AUC0～8（159.10±116.32） ng·h·mL-1 vs. （164.65±129.89） ng·h·mL-1; AUC0～∞（237.12±115.06） ng·h·mL-1 vs. （262.69±155.05） ng·h·mL-1. The relative bioavailability of domestic tablets was （96.63±14.05）% compared with imported tablet. There was no significant difference between the pharmacokinetic parameters of two formulations by variance analysis, t-test and 1-2α confidence interval method. CONCLUSION： The domestic and imported tablets are bioequivalent.