论文部分内容阅读
目的:观察兰索拉唑对消化性溃疡的疗效和患者体内药物动力学及生物利用度.方法:31例消化性溃疡患者随机分成两组.分别po两种兰索拉唑制剂30mg,qd,连续服用1mo后观察疗效,并用HPLC法测定单剂量po后的血药浓度,模拟房室模型并计算药物动力学参数及生物利用度.结果:国产和进口制剂用药后5d内腹痛消失的病人均约占70%,总有效率为100%,组间无明显差别(P>O.05);单剂量po后的血药浓度- 时间曲线均符合一级吸收二室开放模型,主要药物动力学参数c_max分别为(0.58±0.24)和(0.59±0.29)mg/L,T_preak为(1.75±0.92)和(1.88±1.05)h,T_1/zβ分别为(2.66±1.38)和(2.68士1.45)h,AUC_（0→∞）为(2.9571.06)和(3.15±1.35)(mg·h)/L,经统计学分析无明显差别(P>0.05);以进口制剂为参比,国产制剂相对生物利用度为(93.7±33.3)%.结论:两种制剂为生物等效制剂.
Objective: To observe the curative effect of lansoprazole on peptic ulcer and the pharmacokinetics and bioavailability in patients.Methods: 31 patients with peptic ulcer were randomly divided into two groups.P respectively lansoprazole 30mg, qd, After taking 1mo continuously, the curative effect was observed, and the plasma concentration after single-dose po was determined by HPLC, the model of atrioventricular was simulated and the pharmacokinetic parameters and bioavailability were calculated.Results: All the patients with abdominal pain disappeared within 5 days after domestic and imported preparations About 70%, the total effective rate was 100%, no significant difference between groups (P> O.05); single dose po after the plasma concentration-time curve are in line with the first-order absorption two-compartment open model, the main pharmacokinetics The parameters c_max were (0.58 ± 0.24) and (0.59 ± 0.29) mg / L respectively, and the T_preak values were (1.75 ± 0.92) and (1.88 ± 1.05) h and the values of T_1 / zβ were (2.66 ± 1.38 and 2.68 ± 1.45, h, AUC_ (0 → ∞) were (2.9571.06) and (3.15 ± 1.35) (mg · h) / L, respectively. There was no significant difference between the two groups (P> 0.05) The relative bioavailability was (93.7 ± 33.3)%. Conclusion: The two preparations are bioequivalent.