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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)。
Eight healthy male volunteers were randomized to receive 40 mg of Omeprazole capsules (reference drug, C_2) produced by Xinchang Pharmaceutical Co., Ltd. (C_1) and Zhejiang Jinhua Pharmaceutical Factory Utilization study, plasma concentration determined by HPLC method. The results show that the drug-time curves of the two capsules conform to the one-compartment open model. The main pharmacokinetic parameters were as follows: C_ (max) = 2.88 ± 1.06h, C_max = 0.38 ± 0.39mg / L, t_ (1/2) = 1.84 ± 0.95h, AUC_ (0 → ∞) = 1.89 ± 1.94 mg × h / L; T max = 2.54 ± 0.80 h, C max = 0.42 ± 0.41 mg / L and t 1/2 = 1.44 ± 0.66 h in C_2 group, ∞) = 1.86 ± 1.90mg × h / L; The relative bioavailability of C_1 was 101.6%, which was equivalent to C_2 by statistical analysis (P> 0.05).