摘要
8名男性健康志愿受试者,随机交叉一次口服新昌制药股份有限公司产(受试药,C_1)和浙江金华制药厂产奥美拉唑胶囊(参比药,C_2)各40mg,进行人体生物利用度研究,血药浓度用HPLC法测定。研究结果表明:两种胶囊的药-时曲线符合一室开放模型。主要药代动力学参数如下:C_1组T_(max)=2.88±1.06h,C_(max)=0.38±0.39mg/L,t_(1/2)=1.84±0.95h,AUC_(0→∞)=1.89±1.94mg×h/L;C_2组T_(max)=2.54±0.80h,C_(max)=0.42±0.41mg/L,t_(1/2)=1.44±0.66h,AUC_(0→∞)=1.86±1.90mg×h/L;C_1的相对生物利用度为101.6％,经统计分析与C_2等效(P>0.05)。
The pharmacokinetics of both the omeprazole (OPZ) products, which were separatly produced by Xin-chang and Jinhua pharmaceutical companys, were studied in 8 healthy male volunteers after taking orally a single dose of 2 capsules (40mg). The blood concentrations of both OPZs were determined by HPLC. The plasma level-time curves of both OPZs were fitted with one-compartement open model. The main pharmacokinetic parameters of both OPZs were as follows; Xinchang (C1): Tmax = 2.88±1.66h, Cmax = 0.38 ± 0.39mg/L, t1/2 = 1.84±0.95h, AUC 0→∞ =1.89±1.94mgμh/L; Jin-hua(C2): Tmax = 2.54±0.80h, Cmax = 0.42±0.41mg/L, t1/2 = 1.44±0.66h, AUC 0→∞ = 1.86 ±1.90mgμh/L. The relative bioavailability of C1 was 101.6%. It is suggested that the C1 and C2 are equivalent.
出处
《中国药师》
CAS
1998年第4期150-152,共3页
China Pharmacist
