单剂量及多剂量口服奥扎格雷钠口服液的人体药动学研究  

Pharmacokinetic Study on Ozagrel in Twelve Healthy Volunteers

作　　者：金锐[1] 孙考祥[2] 王珍[1] 韩毓博[1] 

机构地区：[1]哈尔滨医科大学附属二院临床药学药物研究所,哈尔滨150086 [2]烟台大学药学院,山东烟台264005

出　　处：《中国药学杂志》2006年第4期296-298,共3页Chinese Pharmaceutical Journal

摘　　要：目的考察奥扎格雷钠在国人中的药动学过程。方法采用双周期试验设计,选用12名健康志愿者单剂量及多剂量po200 mg奥扎格雷钠口服液,建立HPLC测定奥扎格雷钠的血药浓度并计算药动学参数,进而对主要药动学参数进行统计分析。结果单剂量与多剂量的药-时曲线均符合一级吸收的二房室开放模型,其主要药动学参数AUC0-t分别为(3.50±0.90)与(5.87±1.18)mg.h.L-1,AUC0-∞分别为(3.73±0.91)与(6.32±1.29)mg.h.L-1,ρmax分别为(3.10±1.06)与(5.12±1.37)mg.L-1,tmax分别为(0.42±0.12)与(0.50±0.26)h,t1/2β分别为(0.72±0.26)与(0.75±0.99)h。结论单剂量与多剂量给药的主要药动学参数比较ρmax,AUC0-t,AUC0-∞采用Excel进行成对t检验具有极显著性差异(P<0.01)。OBJECTIVE To study the pharmacokinetic profiles of ozagrel in healthy Chinese volunteers.METHODS In a two period study, 12 healthy male volunteers received a single dose and muhiple-dose regimen of 200 mg ozagrel. The plasma concentrations of ozagrel were determined by HPLC. The pharmacokinetic parameters of ozagrel were calculated and analyzed with statistical method. RESULTS The concentration-time curves of a single dose and multiple-dose regimen were fit to a two-compartment open model with first-order absorption. The main pharmacokinetic parameters of a single-dose and multiple-dose regimen ware as follows： A UC0-t（3.50 ± 0.90） and （5.87 ± 1.18） mg·h·L^-1, AUC0-∞ （ 3.73 ± 0.91 ） and （ 6.32 ± 1.29 ） mg·h·L^-1,ρmax （ 3.10 ± 1.06） and （ 5.12 ± 1.37 ） mg·L^-1, tmax （0.42 ± 0.12 ） and （0.50 ± 0.26）h,t1/2β（0.72 ±0.26） and （0.75 ± 0.99）h, respectively. CONCLUSION The statistical analysis shows that there are significant difference after the treatment of a single dose and muhiple-dose regimen.

关 键 词：奥扎格雷钠 单剂量 多剂量 高效液相色谱法 药动学 

分 类 号：R969.1[医药卫生—药理学]