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胶囊及片剂中匹氨西林碱与盐酸盐的药代动力学等效性研究(作者译)

[Studies on the pharmacokinetic equivalence of pivampicillin base and hydrochloride in capsules and tablets (author's transl)].

作者信息

Fedorcak V, Mielenz H, Bozler G

出版信息

Arzneimittelforschung. 1977;27(3):659-65.

PMID:577441
Abstract

Absorption and urinary excretion of pivampicillin as hydrochloride and as base were studied following administration of four different formulations to 12 healthy volunteers in a cross-over study. A fluorimetric assay of ampicillin was adapted to be used with an Auto Analyzer system. The plasma concentrations observed are comparable to those reported in the literature. The amount of drug absorbed is the same for all four medications whereas absorption is more rapid from tablets than from capsules. Base and hydrochloride of pivampicillin are equivalent with respect to pharmacokinetic behaviour. So, the formulation itself seems to be more important for biological equivalence than the ionisation of the drug used in the formulation.

摘要

在一项交叉研究中,对12名健康志愿者给予四种不同制剂后,研究了盐酸匹氨西林及其碱基的吸收和尿排泄情况。将氨苄西林的荧光测定法调整为适用于自动分析仪系统。观察到的血浆浓度与文献报道的浓度相当。所有四种药物的吸收量相同,而片剂的吸收比胶囊更快。匹氨西林的碱基和盐酸盐在药代动力学行为方面相当。因此,制剂本身似乎对生物等效性比制剂中所用药物的离子化更重要。

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