苯磺酸氨氯地平2种片剂的生物等效性比较  

Bioequivalence between two kinds of amlodipine besilate tablets in healthy volunteers

作　　者：张琰[1] 刘梅[1] 文爱东[2] 杨林[2] 李微[2] 袁静[2] 高晓华[2] 

机构地区：[1]中国人民解放军第四军医大学唐都医院药学部,陕西西安710038 [2]中国人民解放军第四军医大学西京医院药学部,陕西西安710032

出　　处：《中国新药与临床杂志》2006年第10期743-746,共4页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的:研究2种苯磺酸氨氯地平片的人体生物等效性。方法:采用双周期交叉试验法,18名健康志愿者单剂量口服苯磺酸氨氯地平10mg,以液相色谱-串联质谱法测定其血浆药物浓度,计算相对生物利用度并评价受试制剂和参比制剂的生物等效性。结果:受试制剂和参比制剂的tmax分别为(8.9±s 2.5)和(8.2±2.2)h;cmax分别为(5.1±2.3)和(5.0±2.2)μg·L-1;t1/2分别为(45±10)和(49±24)h; AUC0-t分别为(191±69)和(196±53)μg·h·L-1;AUC0～∞分别为(225±79)和(243±89)μg·h·L-1。受试制剂的相对生物利用度为(99±23)％。结论:2种片剂在人体内具有生物等效性。AIM： To study the bioequivalence between two kinds of amlodipine besilate tablet formulations in healthy human body. METHODS： Eighteen healthy Chinese male volunteers were included in a randomized, cross-over design. All subjects were administered individually a single 10 mg oral dose of each formulation separated by a 14-day washout period. Plasma amlodipine levels were determined by LC/MS/MS assay. The bioavailability and bioequivalence of the formulations were evaluated. RESULTS： The pharmacokinetic parameters of the test and reference tablets were as follows： tmax were （8.9 ± s 2.5） and （8.2 ± 2.2） h; cmax were （5.1±2.3） and （5.0 ± 2.2）μg·L^-1; t1/2 were （45 ± 10） and （49 ± 24） h; AUC（（0-t） were （191 ± 69） and （196 ± 53） μg·h·L^-1; A UC（0-∞） were （225 ± 79） and （243 ± 89） μg·h·L^-1 respectively. The relative bioavailability of the test tablets was （99 ± 23） %. CONCLUSION： The study demonstrated the two formulations having bioequivalence with each other in healthy human body.

关 键 词：氨氯地平 色谱法 高压液相 药动学 光谱法 质量 大气压化学屯离 生物等效烂 

分 类 号：R969.1[医药卫生—药理学] R972.4[医药卫生—药学]