盐酸氟桂利嗪胶囊人体相对生物利用度研究  

Relative bioavailability of Flunarizine Hydrochloride capsules

作　　者：柘学军[1] 何海霞[1] 杨崇华 陶玉 李召辉[3] 邱峰[1] 

机构地区：[1]重庆医科大学临床学院药剂科,重庆400016 [2]金花企业(集团)股份有限公司高新制药厂,西安710043 [3]重庆医科大学药学系,98级重庆400016

出　　处：《重庆医科大学学报》2001年第2期142-144,150,共4页Journal of Chongqing Medical University

摘　　要：目的：研究盐酸氟桂利嗪胶囊在正常人体内的药代动力学与相对生物利用度。方法：采用HPLC法测定18名健康男性志愿者随机自身交叉单剂量po20mg金花盐酸氟桂利嗪胶囊和杨森盐酸氟桂利嗪胶囊后的血药浓度，计算两者的药代动力学参数及相对生物利用度, 并以AUC（0～24）,Tmax ,Cmax为指标, 用方差分析、单双侧t检验及（1-2a）置信区间法分析金花胶囊与杨森胶囊的生物等效性。结果：金花与杨森盐酸氟桂利嗪胶囊的药-时曲线符合po吸收一房室模型。AUC（0～24） 分别为（391.28±170.77） ng·h/ L与（407.18±174.25）ng·h／L；Tmax分别为（2.89±0.44）h 与(2.97±0.47)h ；Cmax分别为(62.70±21.67) ng/ml与(56.15±15.71)ng/ml；统计学检验结果表明AUC（0～24）, Tmax, Cmax均无显著性差异（Ｐ＞0.05）。结论：金花盐酸氟桂利嗪胶囊对杨森盐酸氟桂利嗪胶囊的相对生物利用度为(96.10±14.07)%，金花与杨森两种盐酸氟桂利嗪胶囊具有生物等效性。Objective: To study relative bioavailability of flunarizine hydrochloride capsules in normal volunteers. Methods: 20mg single oral of Jin Hua flunarizine hydrochloride capsules and Yang Sen flunarizine hydrochloride capsules were given to 18 healthy volunteers in an open randomized crossover study. Flunarizine hydrochloride concentration in plasma were determined by HPLC. The pharmacokinetic parameters as well as relative bioavailability were measured. Results: The concentration-time curves of Jin Hua flunarizine hydrochlo-ride capsules and Yang Sen flunarizine hydrochloride capsules were conformed to a one compartment open model. The AUC（0～24） was (391.28±170.77) μ g·h／L and (407.18±174.25)μ g·h／L, Tmax (2.89±0.44)h and (2.97±0.47)h , Cmax (62.70±21.67) ng/ml and (56.15±15.71)ng·ml-1respectively. There was no significant difference between the two formulations in the AUC（0～6）, tmax, Cmax. Conclusion: The relative bioavailability of Jin Hua flunarizine hydrochloride capsule was (96.10±14.07)% compared with the Yang Sen capsule. The result of the statistical analysis showed that the two formations were bioequivalent.

关 键 词：盐酸氟桂利嗪 药代动力学 相对生物利用度 HPLC 

分 类 号：R971[医药卫生—药品] R969.1[医药卫生—药学]