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[三种品牌奥美拉唑胶囊的生物利用度及其对健康志愿者24小时胃内pH值的影响]

[Bioavailability of three brands of omeprazole capsule and their effects on 24 hour intragastric pH in healthy volunteers].

作者信息

Dong H

机构信息

Medical Technology Assessment and Research Center, Shanghai Medical University. Shanghai 200032.

出版信息

Zhonghua Nei Ke Za Zhi. 1999 Aug;38(8):533-6.

PMID:11798692
Abstract

OBJECTIVE

To compare the bioavailability of three brands of omeprazole capsule (Losec, Aoke-Changzhou No.4 Pharm, Omeprazole-Sanye Pharm) and their effects on 24 hour intragastric pH in healthy volunteers.

METHODS

With crossover design (washout period of 7 days), 18 healthy volunteers (12 men, 6 women) were randomly divided into three groups. Each subject was given the three different brands of omeprazole capsule 40 mg respectively.

RESULTS

The pharmacokinetic study revealed that Losec had an advantage over other two brands of omeprazole capsule in that it was absorbed more rapidly and to a greater extent, resulting in higher plasma concentration and longer staying time in blood. It also showed the shortest latent time in elevating intragastric pH (2.53 hours), the largest net increment in mean gastric pH (3.37), and the greatest prolongation of time with pH > 4 (15.3 hours) among the three products.

CONCLUSION

The three brands of omeprazole capsule are significantly different with respect to their pharmacokinetic process and effects on 24 hour intragastric pH profile. Losec is superior to other two brands of omeprazole capsule in view of its better bioavailability, quicker onset of action, more potent and lasting antisecretory effect.

摘要

目的

比较三种品牌奥美拉唑胶囊(洛赛克、奥克 - 常州四药、奥美拉唑 - 三叶制药)的生物利用度及其对健康志愿者24小时胃内pH值的影响。

方法

采用交叉设计(洗脱期7天),将18名健康志愿者(男12名,女6名)随机分为三组。每位受试者分别服用三种不同品牌的40毫克奥美拉唑胶囊。

结果

药代动力学研究表明,洛赛克在吸收速度和程度上优于其他两种品牌的奥美拉唑胶囊,导致血浆浓度更高,在血液中的停留时间更长。在提高胃内pH值方面,它还显示出最短的潜伏期(2.53小时)、平均胃pH值的最大净增量(3.37)以及三种产品中pH>4的时间延长最多(15.3小时)。

结论

三种品牌的奥美拉唑胶囊在药代动力学过程及其对24小时胃内pH值曲线的影响方面存在显著差异。鉴于其更好的生物利用度、更快的起效速度、更强效和持久的抑酸作用,洛赛克优于其他两种品牌的奥美拉唑胶囊。

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