用HPLC-ESI-MS法研究盐酸氟桂利嗪生物等效性  

Studies on bioequivalence of two nimodipine capsules in healthy volunteers

作　　者：王力江[1] 邹建军[2] 彭向东[3] 刘世坤[3] 李兵[3] 张豫宁[3] 廖海强[3] 

机构地区：[1]中南大学湘雅一医院,湖南长沙410008 [2]南京医科大学附属南京第一医院药品临床研究基地,江苏南京210006 [3]中南大学湘雅三医院,湖南长沙410013

出　　处：《中国现代医学杂志》2005年第9期1410-1412,共3页China Journal of Modern Medicine

摘　　要：目的评价两种国产氟桂利嗪胶囊剂人体生物等效性。方法采用单剂量双交叉实验设计,用HPLC-MS法测定20名健康受试者口服两种氟桂利嗪胶囊20mg后的血药浓度。结果受试制剂和参比制剂药-时曲线均符合一房室模型,t1/2分别为(2.43±0.56)和(2.38±0.43)h,tmax为(2.67±0.82)和(2.74±0.80)h,cmax为(63.37±15.36)和(64.07±14.43)ng/mL,AUC为(130.36±15.20)和(128.47±20.87)ng/(h·mL),受试制剂的相对生物利用度为(101.5±6.3)%。结论经统计学分析,两种国产胶囊具有生物等效性。[Objective]To evaluate the bioequivalence of two domestic Flunarizine capsules. A single oral administration of 20 mg Flunarizine capsule was given to 20 healthy volunteers. Flunarizine concentrations in plasma were determined by HPLC-MS. The main pharmacokinetic parameters of two domestic Flunarizine capsules were as follow: t1/2 (2.43±0.56), (2.38±0.43) h, tmax(2.67±0.82), (2.74±0.80) h, cmax (63.37±15.36), (64.07±14.43) ng/mL,AUC (130.36±15.20), (128.47±20.87) ng/(h·mL) respectively. The relative bioavailability of the test capsule was (101.5±6.3)%. [Conclusion] The results demonstrate that the two capsules are bioequivalent.

关 键 词：氟桂利嗪 药动学 生物等效性 

分 类 号：R972.4[医药卫生—药品]