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[不同药物制剂中溴必利的药代动力学和绝对生物利用度]

[Pharmacokinetics and absolute bioavailability of bromopride from various pharmaceutical formulations].

作者信息

Lücker P W, Tinhof W, Wetzelsberger N, Weyers W, Brodbeck R

出版信息

Arzneimittelforschung. 1983;33(3):453-8.

PMID:6683522
Abstract

Pharmacokinetics and absolute bioavailability of 4-amino-5-bromo-N-[2-(diethylamino)ethyl]-2-methoxybenzamide (bromopride, Viaben), in various preparations (bromopride injection solution, bromopride suppositories for adults, drops and capsules, respectively) in various dosages were calculated. Several investigations were performed: Study I: Absolute bioavailability of bromopride suppositories for adults (cross-over). Study 2: Pharmacokinetics of Bromopride drops after single dose of 15 and 30 mg bromopride as well as after multiple dose of 15 mg bromopride (Confarma). Study 3: Pharmacokinetics of bromopride capsules (Confarma). The chemical analysis was made for all studies with a nearly identical HPLC-method so that the results of the various studies were comparable. The studies led to the following result: The bioavailability of the substance bromopride amounts to about 70% and increases after multiple administration to about 90%. Statistically there is no difference between the bioavailabilities of the individual formulations.

摘要

计算了4-氨基-5-溴-N-[2-(二乙氨基)乙基]-2-甲氧基苯甲酰胺(溴必利,胃复安)在各种剂型(溴必利注射液、成人用溴必利栓剂、滴剂和胶囊)、不同剂量下的药代动力学和绝对生物利用度。进行了多项研究:研究I:成人用溴必利栓剂的绝对生物利用度(交叉试验)。研究2:单次服用15毫克和30毫克溴必利以及多次服用15毫克溴必利后溴必利滴剂的药代动力学(Confarma公司)。研究3:溴必利胶囊的药代动力学(Confarma公司)。所有研究均采用几乎相同的高效液相色谱法进行化学分析,以便各项研究结果具有可比性。研究得出以下结果:溴必利的生物利用度约为70%,多次给药后增加至约90%。从统计学角度来看,各剂型的生物利用度之间没有差异。

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