中国临床药理学杂志2012，Vol.28Issue(3)：179-182,4.
氯沙坦钾片在健康人体的生物等效性
Bioequivalence of losartan potassium tablets in Chinese healthy volunteers
马萍 1李鹏飞 1童卫杭 1孙健姿 1吴诚 1刘丽宏1
作者信息
- 1. 第二炮兵总医院临床药理研究室,北京 100088
- 折叠
摘要
Abstract
Objective To evaluate the bioequivalence of the two losar-tan potassium tablets( angiotensin Ⅱ receptor) in Chinese healthy volun-teers. Methods A single oral dose 50 mg of tested and referened losar-tan potassium tablets were given to 24 volunteers according to an open randomized crossover design. The concentrations of losartan and its active metabolite E3174 in plasma were determined by LC - MS/MS simultane-ously. The pharmacokinetic parameters were caculated and the bioequiv-alence was compared by BAPP 2. 0 program. Results The main phar-macokinetic parameters of losartan of the test and reference preparations were as follows; Cmax were (253. 10 ± 155.43), (232. 37 ± 136. 66) ng ·mL-1;Tmax were (1.09 ±0.70 ), (1. 30 ±0. 80) h;t1/2 were (1. 93 ± 0. 32 ), ( 1. 98 ± 0. 53 ) h; AUC0-12 were ( 454. 19 ± 166. 61 ) , (414. 97 ± 152. 22) ng·h·mL-1, the confidence interval 99.4% -118. 6%. The relative bioavailability of losartan of test preparations was (112. 0 ±29. 9) %. The main pharmacokinetic parameters of E3174 of the test and reference preparations were as follows: Cm were (447. 45 ± 132. 66), (430. 81 ±135.78) ng·mL-1;Tmax were (3.56 ±1.14), (3. 77 ±1.14) h; t1/2 were (4. 55 ±0. 61) ,(4. 67 ±0. 68) h;AUC0-36 were (3522. 17 ±11162. 22) ,(3307. 16 ± 1078. 13) ng·h·mL-1,the confidence interval was 100. 5% - 111. 8%. The relative bioavailability of E3174 of test preparations was (107. 2 ±16. 8)%. The main pharmacokinetic parameters of losartan and E3174 showed no statistically significant difference between two preparations. Conclusion The two preparations were bioequivalent.关键词
氯沙坦钾/B174/液相色谱-串联质谱法/生物等效性Key words
losartan potassium/E3174/LC - MS/MS/bioequivalence分类
医药卫生引用本文复制引用
马萍,李鹏飞,童卫杭,孙健姿,吴诚,刘丽宏..氯沙坦钾片在健康人体的生物等效性[J].中国临床药理学杂志,2012,28(3):179-182,4.
