摘要
目的:建立LC-MS/MS的检测方法,评价受试与参比非那雄胺片在健康人体的生物等效性。方法:健康志愿者24名,随机交叉试验设计,单剂量口服受试或参比制剂,给药剂量均为1mg,应用LC-MS/MS法测定各受试者给药后不同时间点的血药浓度,计算药动学参数,应用BAPP2.0软件进行生物等效性评价。结果:受试与参比制剂的药动学参数如下,AUC0-36分别为(50.317±22.478),(48.586±22.345)μg.h.L-1。AUC0-∞分别为(52.939±24.352),(50.880±23.837)μg.h.L-1;Tmax分别为(1.77±0.44)h、(1.79±0.41)h;Cmax分别为(7.758±3.314),(7.852±3.456)μg.L-1;t1/2分别为(5.10±1.33),(4.96±1.25)h。非那雄胺片的相对生物利用度为(106.0±20.9)%,主要药动学参数经统计学分析无显著性差异。结论:受试与参比制剂具有生物等效性。
OBJECTIVE To study the pharmacokineties and bioequivalence of finasteride tablets in 24 healthy male volunteers by LC-MS/MS assay. METHODS A single oral dose 1 mg of test tablets and reference tablets were given to each volun teers according to an open randomized crossover design. The concentration of finasteride in plasma was determined by LC-MS/ MS. The pharmaeokinetic parameters were calculated and the bioequivalence was compared. RESULTS The main pharmacoki netic parameters of the test and reference preparations were as follows：AUC0-36 were （50. 317 ±22. 478） and （48. 586 ±22. 345）μg·h·L^-1 ; AUC0-∞ were （52. 939 ±24. 352） and （50. 880 ±23. 837）μg·h·L^-1; Tmax were （1.77 ± 0. 44） and （ 1. 79 ±0. 41 ） h; Cmax were （7. 758 ± 3. 314） and （7. 852 ±3. 456）μg·L^-1 ;t1/2 were （5.10±1.33） and （4. 96±1.25） h. The relative bioavailability was（106. 0 ±20. 9）%. The main pharmacokinetic parameters showed no statistically significant difference between 2 prepa rations. CONCLUSION The 2 preparations were bioequivalent.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2010年第20期1745-1748,共4页
Chinese Journal of Hospital Pharmacy
