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吸烟者中普通剂型和缓释剂型维生素C的药代动力学

Vitamin C pharmacokinetics of plain and slow release formulations in smokers.

作者信息

Viscovich Michael, Lykkesfeldt Jens, Poulsen Henrik E

机构信息

Department of Clinical Pharmacology Q 7642, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, DK-2100, Denmark.

出版信息

Clin Nutr. 2004 Oct;23(5):1043-50. doi: 10.1016/j.clnu.2004.01.007.

Abstract

BACKGROUND & AIMS: Combination of the antioxidants ascorbic acid in slow release formulation and alpha-tocopherol can retard the progression of atherosclerosis. In order to determine if differences in formulation could explain some of the different results in the intervention trials we determined selected pharmacokinetics for two different formulations of ascorbic acid together with alpha-tocopherol.

METHODS

Single-blinded, randomised, placebo-controlled intervention study with 48 healthy men, aged 20-65 years, smoking > or = 5 cigarettes/day. Subjects received 250 mg plain release ascorbic acid and 91 mg plain release d-alpha-tocopheryl acetate, 250 mg slow release ascorbic acid and 91 mg plain release d-alpha-tocopheryl acetate or placebo twice daily for 4 weeks. A series of blood samples were collected after administration of the first dose and repeated after 4 weeks of supplementation.

RESULTS

The fluctuation of ascorbic acid plasma concentrations decreased significantly (P = 0.003) after 4 weeks supplementation in the slow versus the plain release group.

CONCLUSIONS

This study shows that there were pharmacokinetic differences between plain and slow release formulations of ascorbic acid. However, these effects are small and unlikely to be of significant clinical importance.

摘要

背景与目的

缓释制剂形式的抗氧化剂抗坏血酸与α-生育酚联合使用可延缓动脉粥样硬化的进展。为了确定制剂差异是否能解释干预试验中的一些不同结果,我们测定了两种不同抗坏血酸制剂与α-生育酚联合使用时的选定药代动力学参数。

方法

对48名年龄在20 - 65岁、每天吸烟≥5支的健康男性进行单盲、随机、安慰剂对照干预研究。受试者每天两次接受250毫克普通释放抗坏血酸和91毫克普通释放d-α-生育酚醋酸酯、250毫克缓释抗坏血酸和91毫克普通释放d-α-生育酚醋酸酯或安慰剂,持续4周。在给予首剂后采集一系列血样,并在补充4周后重复采集。

结果

与普通释放组相比,缓释组补充4周后抗坏血酸血浆浓度的波动显著降低(P = 0.003)。

结论

本研究表明,抗坏血酸普通制剂与缓释制剂之间存在药代动力学差异。然而,这些影响很小,不太可能具有显著的临床重要性。

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