摘要
目的:研究阿魏酸哌嗪胶囊和阿魏酸哌嗪片人体药动学和生物等效性。方法:按照两制剂两周期随机交叉设计,18名男性健康受试者单剂量口服试验胶囊(100mg/粒×2粒)或参比片(50mg/片×4片)。采用HPLC法测定血浆中阿魏酸哌嗪药物浓度。结果:阿魏酸哌嗪胶囊和阿魏酸哌嗪片的AUC0→t分别为(800.4±273.5)μg·h·L-1、(810.1±300.3)μg·h·L-1;AUC0→∞分别为(812.9±273.8)μg·h·L-1、(825.9±302.7)μg·h·L-1;Cmax(实测)分别为(1109.4±394.7)μg·L-1、(1151.1±492.1)μg·L-1;tmax(实测)分别为(0.42±0.12)h、(0.42±0.13)h;t1/2分别为(0.71±0.35)h、(0.8±0.5)h;阿魏酸哌嗪胶囊对阿魏酸哌嗪片的相对生物利用度为101.2%±19.8%。统计分析表明,主要药动学参数AUC0→t、AUC0→∞、Cmax和tmax在2种制剂及给药周期间差异无显著性(P>0.05)。结论:阿魏酸哌嗪胶囊与阿魏酸哌嗪片生物等效。
OBJECTIVE To study the pharmacokinetics and relative bioavailability of piperazine ferulate capsules in healthy Chinese subjects. METHODS 18 subjects were orally given with 200 mg of piperazine ferulate of different preparation forms in an open randomized cross-over test. The plasma concentration of piperazine ferulate was detected by HPLC method. RESULTS The AUC0→t of piperazine ferulate capsules and piperazine ferulate tablets were （800. 4± 273. 5） μg·h·L^-1 and （810. 1 ±300. 3） μg·h·L^-1;AUC0→∞ were （812. 9 ± 273. 8） μg·h·L^-1 and （825. 9 ± 302. 7）μg·h·L^-1 ;Cmax were （1 109. 4 ± 394. 7） μg·L^-1 and （1 151.1 ± 492. 1） μg·L^-1 ;tmax were （0. 42 ± 0. 12） h and （0.42 ± 0. 13） h;t1/2 were （0. 71 ± 0. 35） h and （0. 8 ± 0. 5）h,respectively. The relative bioavailability of piperazine ferulate capsules were 101.2% ± 19. 8% compared with piperazine ferulate tablets. There was no significant differences of pharraaeokinetic parameters as AUC0→t, AUC0→∞, Cmax and tmax between two drugs （P〉0.05）. CONCLUSION Piperazine ferulate capsules and piperazine ferulate tablets are bioequivalent.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2009年第12期994-997,共4页
Chinese Journal of Hospital Pharmacy
