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目的观察抑酸药(法莫替丁、鼠李铋镁)对马来酸多潘立酮(健胃药)在健康人体药代动力学的影响。方法10名健康受试者未服和服用抑酸药后,单剂量口服马来酸多潘立酮10mg,用LC/MS/MS测定血药浓度,用Win-NonLin5.0软件计算药代动力学参数,并用Spss12.0软件比较主要药代动力学参数。结果未服和服用抑酸药后,单剂量口服马来酸多潘立酮,其药代动力学参数如下:tmax分别为(0.85±0.24)、(2.20±1.78)h,Cmax分别为(9.68±5.37)、(7.18±4.12)μg.L-1,AUC0～tn分别为(38.18±19.76)、(49.96±10.35)μg.h.L-1。显示服用抑酸药后,马来酸多潘立酮的tmax延长,有显著性差异(P=0.04);AUC0-tn增加,峰浓度降低,但无显著性差异(分别为P=0.1、0.06)。结论在健康人体内,法莫替丁、鼠李铋镁不影响马来酸多潘立酮的吸收程度;但使其吸收速度减慢。
Objective To observe the pharmacokinetics of famotidine maleate and bismuth magnesium in healthy volunteers. Methods Ten healthy volunteers were given 10 mg of oral domperidone maleate without taking the antacids. The plasma concentrations of the drugs were determined by LC / MS / MS. The pharmacokinetic parameters were calculated by Win-NonLin 5.0 software. Spss12.0 software was used to compare the main pharmacokinetic parameters. Results The pharmacokinetic parameters of oral domperidone maleate were as follows: tmax were (0.85 ± 0.24) and (2.20 ± 1.78) h respectively, and Cmax were (9.68 ± 5.37) and , (7.18 ± 4.12) μg.L-1 and AUC0 ~ tn were (38.18 ± 19.76) and (49.96 ± 10.35) μg.hL-1, respectively. The tmax of domperidone maleate was prolonged after administration of antacids, showing significant differences (P = 0.04); AUC0-tn increased and peak concentrations decreased but with no significant difference (P = 0.1, 0.06, respectively). Conclusions Famotidine and bismuth did not affect the absorption of domperidone maleate in healthy volunteers, but slowed its absorption.