摘要
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.
AIM: To investigate the curative effect, pharmacokinetics and relative bioavailability of lansoprazole domestic and imported products in the patients suffering from peptic ulcer. METHODS: The lansoprazole concentrations in serum of 31 patients were de-termined by high performance liquid chromatography method following a single oral dose of 30 mg lansoprazole capsule made in China and Japan. The pharmacokinetic parameters were computed with PKBP-N1 program. The patients were treated with lansoprazole 30 mg/d and the therapeutic courses were all 1 mo. Within 3 d after the therapeutic courses, all of the pa-tients were reexamined with gastroscopy. RESULTS: After 1 mo of medication, the total effective rate was 100% for each group (P>0. 05). Following a single oral lansoprazole, theconcentration-time curves of the domestic and imported products fitted to two compartmen-topen model. There were no signi-ficant differences in each pharmacokinetic parameters be-tween the 2 products (P>0. 05). c_(max) of domestic and imported lansoprazole capsule were (0. 58 ± 0. 24) and (0. 59 ± 0. 29)mg/L, T_(peak) wre (1. 75 ± 0. 92) and (1. 88 ± 1. 05)h, T_(1/2β) were (2.66 ± 1.38) and (2.68 ± 1. 45)h, AUC_(0→∞) were (2. 95 ± 1. 06) and (3.15 ± 1. 35) (mg · h)/L, respectively. The relative bioavailability of domestic lansoprazole was (93. 7 ± 33. 3%). CONCLUSION: There is bioequivalent between the 2 products.
出处
《中国临床药学杂志》
CAS
1999年第5期278-282,共5页
Chinese Journal of Clinical Pharmacy
