【作者】 卢晓阳； 申屠建中； 周惠丽； 郑国刚； 陈志根； 黄明珠； 史美甫；

【Author】 SHENG-TU Jian-zhong LU Xiao-yang Zhou hui-li Zheng guo-gang CHEN Zhi-gen HUANG Ming-zhu SHI Mei-fu (Department of clinical pharmacology, the First Affiliated Hospital, College of Medical, Zhejiang University, Hangzhou 310003; Zhejiang Institute for Drug Control, Hangzhou 310016 )

【机构】 浙江大学医学院附属第一医院临床药理研究室； 浙江省药品检验所；

【摘要】 目的:评价国产雷米普利胶囊与已上市的雷米普利片的人体生物等效性。方法:18名男性健康志愿者随机交叉口服雷米普利受试制剂和参比制剂各10mg,采用液相色谱-质谱法测定血清药物浓度。结果:雷米普利参比制剂及受试制剂的tmax分别为(0.61±0.22)和(0.60±0.19)h,cmax 分别为(15.66±4.24)和(15.99±4.29)μg·mL-1,AUC0-10分别为(34.25±8.95)和(33.40±7.56)μg·h·mL-1, t1/2 (ke)分别为(1.35±0.34)和(1.32±0.39)h,国产雷米普利胶囊相对生物利用度为(98.81±12.05)%。结论:方差分析和双单侧t检验结果表明两种制剂生物等效。更多还原

【Abstract】 OBJECTIVE To evaluate the bioequivalence of domestic Ramipril capsule and imported Ramipril capsule in the healthy volunteers. METHODS A single oral dose of 800mg test or reference preparations of Ramipril was given to 18 healthy volunteers in a randomized crossover study. The serum concentrations of Ramipril were determined by HPLC-MS assay. RESULTS The main pharmacokinetics parameters of the two products were as follow: tmax(0.61±0.22) and (0.60±0.19) h; cw (15.66±4.24) and (15.99±4.29) μg·mL-1; AUC0-10 (34.25±8.95) and (33.40±7.56) μg·h·mL-1; t1/2<ke> (1.35±0.34) and (1.32±0.39) h, respectively. The relative bioavailability of the test to reference capsule was (98.81±12.05) %. CONCLUSION The results of variance analysis and two one-side t test showed that the two formulations were bioequivalent.更多还原