盐酸氟桂利嗪片在健康人体中的相对生物利用度

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50 mg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(1 686±216)μg·h·L-1和(1 755±151)μg·L-1；Cmax分别为(172±14)μg·L-1和(165±15)μg·L-1；Tmax分别为(3.27±O.19)h和(3.32±0.22)h。受试制剂的相对生物利用度为(103.7±7.7)％。结论：2制剂具有生物等效性。

Relative bioavailability of flunarizine in healthy volunteers by HPLC

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 50mg by high-performance liquid chromatography (HPLC).Results: The plasma concentration-time curves of these two drugs ap-peared 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 Cmaxvalues were (172±14)μg·L-1 and (165±15)μg·L-1 and the Tmax values were(3.27±0.19)h and (3.32±0.22) h, respective-ly. Relative bioavailability of tablet from Henan was (103.7±7.7)％ as compared with the tabiet from Hderbin. Corclusion: Thetwo preparations are bioequivalent.