【摘要】 目的:研究2种盐酸氟桂利嗪胶囊的生物等效性。方法:采用两制剂双周期自身对照交叉试验设计,18例健康男性志愿者分别口服单剂量2种盐酸氟桂利嗪胶囊各20 mg(参比制剂和受试制剂),用高效液相色谱(HPLC)紫外检测法测定血浆中氟桂利嗪的浓度,采用DAS1.0程序对药动学参数进行方差分析和双单侧t检验。结果:参比制剂和受试制剂在受试者体内的药动学参数分别为:Cm ax(74.76±16.14)和(70.50±14.96)μg.L-1;Tmax(2.61±0.53)和(2.53±0.36)h;t1/2(6.45±1.13)和(6.48±1.19)h;AUC0-24 h(693.7±170.7)和(686.7±187.4)μg.h.L-1,AUC0-∞分别为(753.4±178.5)和(746.1±189.8)μg.h.L-1,受试制剂对参比制剂的平均相对生物利用度F0-∞为(99.7±16.2)%。AUC0-24 h90%置信区间为0.921-1.049,Cm ax90%置信区间为0.893-1.000,Tm ax经非参数法检验,差异无统计学意义。结论:2种盐酸氟桂利嗪胶囊生物等效。更多还原

【Abstract】 Objective: To study the pharmacokinetics and bioequivalence of flunarizine hydrochloride capsules.Methods: 18 healthy male volunteers were randomly administered with an oral single crossover dose of test and reference flunarizine capsules 20mg.The plasma samples from the volunteers were collected to measure flunarizine concentrations by HPLC-UV.The pharmacokinetic parameters as well as bioequivalence of both flunarizine capsules were analyzed using DAS1.0 program,ANOVA and two-one-sided t-test.Results: The main pharmacokinetic parameters of the reference and test flunarizine capsules were as follows: C_max（74.76±16.14）vs.（70.50±14.96）μg·L-1,T_max（2.61±0.53）vs.（2.53±0.36）h,t₁/2（6.45±1.13）vs.（6.48±1.19）h,AUC₀²4h（693.7±170.7）vs.（686.7±187.4）μg·h·L-1 and AUC₀^∞（753.4±178.5）vs.（746.1±189.8）μg·h·L-1.The relative bioavailability of test capsules was F₀^∞（99.7±16.2）%.The 90% confidence interval of AUC₀²4h and C_max was 0.921¹.049 and 0.893¹.000,respectively.Conclusion: The reference and test flunarizine capsules were bioequivalent.更多还原