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首页> 外文期刊>European journal of drug metabolism and pharmacokinetics >Is one paracetamol suppository of 1000 mg bioequivalent with two suppositories of 500 mg.
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Is one paracetamol suppository of 1000 mg bioequivalent with two suppositories of 500 mg.

机译:是一种生物等效的1000 mg对乙酰氨基酚栓剂和500 mg两种栓剂。

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摘要

A common belief is that one tablet or suppository containing, e.g. 100 mg of a drug can be substituted, without any changes in the therapeutic effect, with two units of the same brand containing 50 mg of the drug. In the present study a single dose of paracetamol was administered to healthy volunteers as (a) two tablets of 500 mg, (b) two suppositories of 500 mg, and (c) one suppository of 1000 mg. There were statistically significant differences in all bioavailability parameters (t(max), C(max) and AUC) between the three treatments. The relative bioavailability of the 500 mg suppositories was 77% and that of the 1000 mg suppositories 66%. The absorption rate from suppositories was markedly lower than from the tablets. Especially low absorption rate was obtained with the suppository of 1000 mg. The two strengths, although having the same trade name, were not therefore bioequivalent.
机译:普遍认为一种片剂或栓剂含有例如可以用相同品牌的两个单位含有50 mg的药物代替100 mg的药物,而不会改变治疗效果。在本研究中,单剂量对乙酰氨基酚以(a)两片500 mg的片剂,(b)两片500 mg的栓剂和(c)一片1000 mg的栓剂施用于健康志愿者。三种处理之间所有生物利用度参数(t(最大值),C(最大值)和AUC)在统计学上都有显着差异。 500 mg栓剂的相对生物利用度为77%,而1000 mg栓剂的相对生物利用度为66%。栓剂的吸收率明显低于片剂。用1000mg栓剂获得特别低的吸收率。尽管这两个优点具有相同的商品名,但因此在生物学上并不等效。

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