盐酸氟桂利嗪分散片和胶囊的生物等效性研究  

Research on bioequivalence of flunarizine hydrochloride dispersible tablets in healthy volunteers

作　　者：赵艳[1] 刘振胜[1] 李志平[1] 赵美玲[2] 齐方梅[3] 王少华[1] 

机构地区：[1]青岛市市立医院国家药品临床研究基地 [2]青岛市市立医院国家药品临床研究基地干部保健病房 [3]青岛市市立医院国家药品临床研究基地耳鼻喉科

出　　处：《中国临床药理学与治疗学》2004年第11期1305-1308,共4页Chinese Journal of Clinical Pharmacology and Therapeutics

摘　　要：目的:研究盐酸氟桂利嗪分散片药代动力学及生物等效性。方法:20名健康受试者按体重指数进行分层随机交叉服用盐酸氟桂利嗪试验制剂和参比试剂20 mg,采用高效液相色谱法测定盐酸氟桂利嗪的血药浓度。结果:口服20 mg被试制剂与参比制剂后,盐酸氟桂利嗪AUC0-t分别为424.27±74.01和410.25±72.56μg·h-1·L-1;Cmax分别为67.02±14.89和67.45±15.68μg·L-1;Tmax分别为2.90±0.42和2.98±0.47 h;t1/2ke分别为9.73±3.15和8.89±3.08 h。试验制剂的相对生物利用度为(104.12±12.23)％。结论:盐酸氟桂利嗪分散片和胶囊具有生物等效性。AIM: To study the bioequivalence between flunarizine hydrochloride dispersible tablets and capsules in healthy volunteers. METHODS: A single dose of 20 mg flunarizine hydrochloride dispersible tablets and capsules were given to 20 healthy volunteers by a randomized, two way cross-over design. Plasma concentrations of flunarizine hydrochloride were determined by HPLC. RESULTS: The pharmacokinetic parameters after administration of flunarizine hydrochloride dispersible tablets and contrast flunarizine hydrochloride capsules (20mg) were as follows: AUC0-1 424.27 ±74.01 and 410.25±72.56μg·L-1, Cmax67.02±14.89 and 67.45±15.68 μg·L-1, Tmax2.90±0.42 and 2.98±0.47 h, and t1/2ke 9.73±3.15 and 8.89 ±3.08 h, respectively. The relative bioavailability of the flunarizine hydrochloride tablets was (104.12± 12.23)% . CONCLUSION: Two formations of flunarizine hydrochloride are bioequivalent.

关 键 词：盐酸氟桂利嗪 高效液相色谱法 药代动力学 生物利用度 分散片 

分 类 号：R969.1[医药卫生—药理学]