马来酸依那普利片的健康人体生物等效性  

Bioequivalence of enalapril maleate tablets in healthy volunteers

作　　者：李军伟[1] 周云芳 邱相君[3] 胡国新[1] 代宗顺[4] 

机构地区：[1]温州医学院药学院药理教研室,浙江温州325035 [2]丽水市第二人民医院药剂科,浙江丽水323000 [3]河南科技大学医学院药理学教研室,河南洛阳471003 [4]华中科技大学同济医学院临床药理研究所,湖北武汉430030

出　　处：《中国医院药学杂志》2008年第19期1685-1688,共4页Chinese Journal of Hospital Pharmacy

摘　　要：目的:研究马来酸依那普利片的人体相对生物利用度和生物等效性。方法:健康志愿者20名,随机双交叉单剂量口服马来酸依那普利片试验制剂和参比制剂,剂量分别为20mg,用高效液相色谱(HPLC)法测定血浆中依那普利的浓度。用DAS药动学程序计算相对生物利用度并评价两种制剂生物等效性。结果:受试制剂与参比制剂的Cmax分别为(272.6±42.2)μg.L-1和(263.5±42.2)μg.L-1;tmax分别为(0.81±0.11)h和(0.80±0.10)h;AUC(0-∞)分别为(664.7±105.1)μg.h.L-1和(661.2±99.5)μg.h.L-1;AUC(0-inf)分别为(698.0±116.3)μg.h.L-1和(689.0±106.0)μg.h.L-1。试验制剂与参比制剂的人体相对生物利用度为(102.3±19.7)%,结论:试验制剂与参比制剂具有生物学等效性。OBJECTIVE evaluate the relative bioavailability and bioequivalence of enalapril maleate tablets of test and refer ence formulations in healthy volunteers. METHODS In a randomized crossover study, a single oral dose of 20 mg test and reference formulations was given to 20 healthy male volunteers. The plasma concentrations of Enalapril were determined by HPLC. The pharrnacokinetic parameters were calculated and the bioequivalence of two formulations were evaluated by DAS 2.0 software. RESULTS The main pharmacokinetic parameters of the test and the reference formulations were as follows： Cmax were （272.6 ± 42.2）μg·L^-1 and （263.5 ± 42. 2）μg·L^-1; tmax were （0. 81 ±0. 11）h and （0. 80 ± 0. 10） h; AUC（0-8）were （664. 7 ± 105.1）μg·h·L^-1 and （661.2 ± 99. 5）μg·h·L^-1; AUC（0-mf） were （698.0 ± 116. 3）μg·h·L^-1 and （689. 0 ± 106. 0） μg·h·L^-1 , respectively. The relative bioavailability of the test tablet was （102. 3 ± 19.7） %. CONCLUSION The two formulations were bioequivalent.

关 键 词：依那普利 药动学 生物等效性 高效液相色谱法 

分 类 号：R969.1[医药卫生—药理学]