盐酸氟桂利嗪片在健康人体中的相对生物利用度

Relative bioavailability of flunarizine in healthy volunteers by HPLC

目的 :研究盐酸氟桂利嗪片在健康人体中的药物动力学及相对生物利用度。方法 :以哈尔滨北方制药厂生产的盐酸氟桂利嗪片为参比制剂 ,河南省濮阳市第二制药厂研制的盐酸氟桂利嗪片为受试制剂。采用高效液相色谱法 (HPLC)测定 8名志愿者单剂量交叉口服 5 0mg盐酸氟桂利嗪片后不同时刻的血药浓度。结果 :2制剂的血药浓度 时间曲线均符合一房室开放模型。其AUC分别为 (16 86± 2 16 ) μg·h·L-1和 (175 5± 15 1) μg·h·L-1;Cmax分别为 (172± 14) μg·L-1和 (16 5± 15 ) μg·L-1;Tmax分别为 (3 2 7± 0 19)h和 (3 32± 0 2 2 )h。受试制剂的相对生物利用度为 (10 3 7± 7 7) %。结论 :2制剂具有生物等效性。

Aim: To study the pharmacokinetics and relative bioavailability of flunarizine in healthy volunteers Methods: The plasma concentrations of flunarizine for two preparations were determined in 8 healthy male volunteers after an oral dose of 50 mg by high performance liquid chromatography (HPLC) Results: The plasma concentration time curves of these two drugs appeared to fit to one compartment open model The AUC were (1 686±216)μg·h·L -1 and (1 755±151)μg·h·L -1 and the C max values were (172±14)μg·L -1 and (165±15)μg·L -1 and the T max values were(3 27±0 19)h and (3 32±0 22)h,respectively Relative bioavailability of tablet from Henan was (103 7±7 7)% as compared with the tablet from Hderbin Conclusion: The two preparations are bioequivalent