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五种品牌的三水合氨苄西林胶囊的生物等效性研究。

Bioequivalence studies of five brands of ampicillin trihydrate capsules.

作者信息

Hamid S, Beg A E

出版信息

Arch Int Pharmacodyn Ther. 1987 Mar;286(1):15-22.

PMID:3592855
Abstract

Using the microbiological assay method, the bioavailability of ampicillin in healthy human volunteers has been examined. The plasma levels were used to determine the extent and rate of bioavailability following oral administration of 250 mg capsules produced by 5 different manufacturers. Balanced incomplete block design was employed and standard statistical techniques were used to detect any significant difference between multivariate and univariate characteristics. The results indicate that the different brands are almost bioequivalent with respect to the rate of bioavailability but that they are bioinequivalent with respect to the extent of bioavailability.

摘要

采用微生物测定法,对氨苄西林在健康人体志愿者中的生物利用度进行了检测。口服由5家不同制造商生产的250毫克胶囊后,利用血浆水平来确定生物利用度的程度和速率。采用平衡不完全区组设计,并运用标准统计技术来检测多变量和单变量特征之间的任何显著差异。结果表明,不同品牌在生物利用度速率方面几乎生物等效,但在生物利用度程度方面则生物不等效。

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