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研究国产吗氯贝胺的耐受性、药代动力学和生物利用度。耐受性研究 :正常健康志愿者9人和抑郁症病人6人分为三组 ,每组分别口服150、300和600mg 的吗氯贝胺。结果显示 ,在所试剂量范围内 ,该药耐受性良好。药代动力学和生物利用度研究 :健康志愿者12人 ,男女各半 ,口服300mg吗氯贝胺 ,采用高效液相色谱法测定血浆药物浓度 ,估算药代动力学参数。结果显示 ,国产和进口吗氯贝胺的T1/2β 分别为2.13±0.59h和2.10±0.78h ;Tmax 分别为1.54±0.75h和1.40±1.04h ;Cmax 分别为3118±1256μg·L-1 和2937±844μg·L-1;AUC0 -24 13.80±4.31mg·h·L-1 和11.98±3.78mg·h·L-1。方差分析统计 ,主要药代动力学参数无显著性差异(P>0.05);双单侧T检验和 (1 -2α)置信区间法 ,两种制剂不具有生物等效性。
To investigate the tolerability, pharmacokinetics and bioavailability of domestic moclobemide. Tolerability Study: Nine healthy volunteers and six patients with depression were divided into three groups, each of which received 150, 300 and 600 mg of moclobemide orally. The results show that the drug is well tolerated within the range of doses tested. Pharmacokinetics and bioavailability study: 12 healthy volunteers, half men and women, oral administration of mocobcycline 300mg, high-performance liquid chromatography determination of plasma drug concentration, pharmacokinetic parameters. The results showed that the ratio of T1 / 2β of domestic and imported moclobemide was 2.13 ± 0.59h and 2.10 ± 0.78h respectively; the Tmax was 1.54 ± 0.75h and 1.40 ± 1.04h respectively; the Cmax were 3118 ± 1256μg · L-1 and 2937 ± 844 μg · L-1; AUC0 -24 13.80 ± 4.31 mg · h · L-1 and 11.98 ± 3.78 mg · h · L-1. Analysis of variance showed no significant difference in the main pharmacokinetic parameters (P> 0.05). Two-sided unilateral T-test and (1-2a) confidence interval method showed no bioequivalence between the two preparations.