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一项生物利用度研究,在单次给药后,对十二名健康女性志愿者比较两种含锌口服制剂(双甘氨酸锌与葡萄糖酸锌)。

A bioavailability study comparing two oral formulations containing zinc (Zn bis-glycinate vs. Zn gluconate) after a single administration to twelve healthy female volunteers.

作者信息

Gandia Peggy, Bour Dorothée, Maurette Jean-Marc, Donazzolo Yves, Duchène Patrick, Béjot Marie, Houin Georges

机构信息

Laboratoire Cinétique des Xénobiotiques, Faculté de Pharmacie, 35 chemin des Maraîches, 31062 Toulouse 4, France.

出版信息

Int J Vitam Nutr Res. 2007 Jul;77(4):243-8. doi: 10.1024/0300-9831.77.4.243.

Abstract

As the current nutritional zinc intake frequently falls outside the Dietary Reference Intake (DRI) and as zinc is an essential trace mineral involved in the function of many enzymes, zinc supplementation has been recommended to prevent or treat the adverse effects of zinc deficiency. The aim of the present study was to compare the oral bioavailability of zinc bis-glycinate (a new formulation) with zinc gluconate (reference formulation). A randomized, cross-over study was conducted in 12 female volunteers. The two products were administrated orally at the single dose of 15 mg (7.5 mg x 2), with a 7-day wash-out period between the two tests. Serum concentrations of zinc were assayed by a validated inductively coupled plasma optical emission spectrometry (ICP-OES) method and C(max), T(max), and areas-under-the-curve (AUCs) were determined. The comparison between the two treatments was performed by comparing the C(max), AUC(t), and AUC(inf) using an analysis of variance followed by the calculation of the 90% confidence intervals of the ratio test/reference. Bis-glycinate administration was safe and well tolerated and bis-glycinate significantly increased the oral bioavailability of zinc (+43.4%) compared with the gluconate.

摘要

由于当前膳食锌摄入量常常超出膳食参考摄入量(DRI),且锌是一种参与多种酶功能的必需微量矿物质,因此推荐补充锌以预防或治疗锌缺乏的不良影响。本研究的目的是比较双甘氨酸锌(一种新制剂)和葡萄糖酸锌(参比制剂)的口服生物利用度。在12名女性志愿者中进行了一项随机交叉研究。两种产品均以15 mg(7.5 mg×2)的单剂量口服给药,两次测试之间有7天的洗脱期。采用经过验证的电感耦合等离子体发射光谱法(ICP-OES)测定血清锌浓度,并确定C(max)、T(max)和曲线下面积(AUC)。通过使用方差分析比较C(max)、AUC(t)和AUC(inf),然后计算比值测试/参比的90%置信区间,对两种治疗方法进行比较。双甘氨酸锌给药安全且耐受性良好,与葡萄糖酸锌相比,双甘氨酸锌显著提高了锌的口服生物利用度(提高了43.4%)。

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