盐酸氟桂利嗪胶囊的人体相对生物利用度研究

 目的研究两种盐酸氟桂利嗪胶囊的人体相对生物利用度。方法按照随机交叉试验设计，20名健康男性志愿者分别po单剂量两种盐酸氟桂利嗪胶囊20mg，用液相色谱 质谱联用方法测定血浆中氟桂利嗪的浓度，采用NDST程序对药动学参数进行方差分析和双单侧t检验。结果受试制剂和参比制剂在受试者体内的药动学参数如下：c_max分别为(53±15) 和(52±15) ng·mL^{-1，t_max分别为(3.0±0.8)和(3.3±1.3) h，t_1/2分别为(8.1±1.2)和(8.2±2.0) h，AUC_0～24分别为(539±206)和(503±156) ng·h·mL-1，受试制剂对参比制剂的相对生物利用度为(105.6±16.2)%。结论两种制剂具有生物等效性。}

Study on relative bioavailability of two flunarizine hydrochloride capsules

OBJECTIVE To study the relative bioavailability of two flunarizine hydrochloride capsules in human. METHODS A single oral dose of 20 mg flunarizine hydrochloride capsules was given to 20 healthy male volunteers according to a randomized crossover design.The concentrations of flunarizine in plasma were determined by HPLC/MS assay.The pharmacokinetic parameters were processed with NDST program for variance analysis and two one-sided t test. RESULTS The main pharmacokinetic parameters of the test and the reference capsules were as follow:c_max(53±15)ng·mL^{-1and (52±15) ng·mL-1,t_max(3.0±0.8) and (3.3±1.3) h,t_1/2(8.1±1.2) and (8.2±2.0) h,AUC_0～24(539±206) and (503±156) ng·h·mL-1, respectively.The relative bioavailability of the test capsules was(105.6±16.2)%. CONCLUSION The two capsules were bioequivalent.}