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双氯芬酸钠两种肠溶衣片制剂的相对生物利用度

Comparative bioavailability of two enteric-coated tablet preparations of diclofenac sodium.

作者信息

Paton D M

出版信息

Int J Clin Pharmacol Res. 1987;7(4):239-42.

PMID:3596865
Abstract

In a random cross-over study, eight healthy volunteers received single 25 mg doses of enteric-coated diclofenac sodium tablets (as either Voltaren 25, Ciba-Geigy or Anfenax 25, Istituto Biochimico Italiano) after an overnight fast. The bioavailability of these two preparations of diclofenac sodium did not differ significantly as judged by absorption lag time, peak plasma concentration, time to peak plasma concentrations or area under the plasma concentration-time curve. Diclofenac was found to have a plasma clearance of 2.85 +/- 1.03 (s.d.) and 3.39 +/- 1.43 ml min-1 kg-1, a plasma terminal half-life of elimination of 0.61 +/- 0.25 and 0.71 +/- 0.39 h, and an apparent volume of distribution of 0.15 +/- 0.10 and 0.21 +/- 0.13 l kg-1 (the values obtained with the Ciba-Geigy preparation being shown before the Istituto Biochimico Italiano preparation in each case).

摘要

在一项随机交叉研究中,8名健康志愿者在禁食过夜后单次服用25毫克肠溶双氯芬酸钠片(分别为Ciba-Geigy公司的扶他林25或意大利生物化学研究所的安芬那克25)。根据吸收滞后时间、血浆峰值浓度、达到血浆峰值浓度的时间或血浆浓度-时间曲线下面积判断,这两种双氯芬酸钠制剂的生物利用度没有显著差异。发现双氯芬酸的血浆清除率分别为2.85±1.03(标准差)和3.39±1.43毫升/分钟·千克-1,血浆消除终末半衰期分别为0.61±0.25和0.71±0.39小时,表观分布容积分别为0.15±0.10和0.21±0.13升/千克-1(每种情况下,Ciba-Geigy公司制剂的数据列于意大利生物化学研究所制剂数据之前)。

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