【摘要】 目的:评价2种盐酸氟桂利嗪胶囊在正常人体内的生物等效性。方法:20名健康志愿受试者分别单剂量交叉口服2种盐酸氟桂利嗪胶囊(FZJ或FZY)20mg,以高效液相色谱法测定血药浓度,3p97计算药动学参数与相对生物利用度。结果:FZJ和FZY在体内药-时曲线呈一室模型,tmax分别为(2·89±0·44)、(2·97±0·47)h,Cmax分别为(62·70±21·67)、(56·15±15·71)μg/ml,AUC(0~t)分别为(391·28±170·77)、(407·18±174·25)(μg·h)/ml,二者比较无显著性差异(P>0·05),FZJ的相对生物利用度为(96·10±14·07)%。结论:2种制剂具有生物等效性。更多还原

【Abstract】 OBJECTVE:To evaluate the bioequivalence of2different flunarizine capsules in healthy volunteers.METH-ODS:A total of20healthy volunteers were ascribed to receive single oral dose of2flunarizine preparations(FZJ or FZY)by a randomized crossover way,the plasma concentrations of flunarizine were determined by HPLC,the pharmacokinetics parame-ters and the bioequivalence were calculated with3p97program.RESULTS:The concentration-time curves of FZJ and FZY fitted to one-compartment model,the pharmacokinetics parameters of FZJ vs.FZY were stated as the following,t max (2.89±0.44)h vs.(2.97±0.47)h,C max (62.70±21.67)vs.(56.15±15.71)μg/ml;AUC (0～t) (391.28±170.77)vs.(407.18±174.25)(μg·h)/ml,no significant difference was noted between2groups in pharmacokinetics parameters(P>0.05),the relative bioavailability of FZJ was(96.10±14.07)%.CONCLUSION:2kinds of capsules are bioequivalent.更多还原