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蔗糖酸镁给药后的镁生物利用度:一项离体研究和一项健康受试者中比较性、双盲、交叉研究的结果。

Magnesium bioavailability after administration of sucrosomial® magnesium: results of an ex-vivo study and a comparative, double-blinded, cross-over study in healthy subjects.

机构信息

PharmaNutra S.p.A. Pisa, Italy.

出版信息

Eur Rev Med Pharmacol Sci. 2018 Mar;22(6):1843-1851. doi: 10.26355/eurrev_201803_14605.

Abstract

OBJECTIVE

We conducted an ex-vivo analysis and a study in healthy subjects to compare magnesium bioavailability after administration of Sucrosomial® magnesium or commercially available preparations of magnesium citrate, magnesium oxide and magnesium bisglycinate.

MATERIALS AND METHODS

In the ex-vivo study we simulated magnesium intestinal absorption after digestion through sections of intestinal mucosa isolated from rats. We compared the absorption of magnesium oxide and Sucrosomial® magnesium at two different concentrations: 32.9 mg/ml and 329 mg/ml. The human study was a single day double-blinded repeated crossover study in healthy subjects. Each subject was administered 350 mg magnesium in different formulations (Sucrosomial® magnesium, magnesium citrate, magnesium oxide or magnesium bisglycinate) after 1 week of washout. We collected blood and urine samples to measure magnesium concentration in blood, urine and red blood cells.

RESULTS

The ex-vivo evaluation showed that magnesium absorption after administration of Sucrosomial® magnesium was faster and with higher rates compared to a standard formulation of magnesium oxide. This finding was further confirmed by the results of the study in healthy subjects, that showed a more evident increase in magnesium concentration after administration of Sucrosomial® magnesium compared to the other formulations. In particular, the increase in magnesium concentration from baseline to 24 h was statistically higher in blood and in urine for Sucrosomial® magnesium compared to magnesium oxide, while in red blood cells Sucrosomial® magnesium had a statistically significant advantage compared to magnesium bisglycinate.

CONCLUSIONS

Our findings suggest that Sucrosomial® magnesium leads to an increased bioavailability of magnesium compared to other formulations. Further studies are needed to investigate if this advantage turns into more evident clinical efficacy.

摘要

目的

我们进行了一项离体分析和一项健康受试者研究,以比较施用苏糖酸镁(Sucrosomial® magnesium)与市售柠檬酸镁、氧化镁和甘氨酸镁制剂后镁的生物利用度。

材料和方法

在离体研究中,我们通过模拟消化过程,使用从大鼠分离的肠黏膜段来比较氧化镁和苏糖酸镁的吸收。我们比较了两种不同浓度(32.9 mg/ml 和 329 mg/ml)的氧化镁和苏糖酸镁的吸收。在健康受试者的单日内双盲交叉研究中,我们进行了一项单次研究。每位受试者在洗脱期 1 周后,分别给予 350mg 不同配方(苏糖酸镁、柠檬酸镁、氧化镁或甘氨酸镁)的镁。我们采集血样和尿样,以测量血、尿和红细胞中的镁浓度。

结果

离体评价显示,与标准氧化镁制剂相比,施用苏糖酸镁后镁的吸收更快,吸收速率更高。这一发现进一步得到了健康受试者研究结果的证实,该研究表明,与其他配方相比,施用苏糖酸镁后,血中和尿中镁浓度的增加更为明显。特别是,与氧化镁相比,苏糖酸镁在血和尿中的镁浓度从基线到 24 小时的增加在统计学上更高,而在红细胞中,苏糖酸镁与甘氨酸镁相比具有统计学显著优势。

结论

我们的研究结果表明,与其他配方相比,苏糖酸镁可提高镁的生物利用度。需要进一步研究以确定这种优势是否转化为更明显的临床疗效。

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