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葡庚糖酸钙与碳酸钙的相对生物利用度和药代动力学比较。

Relative bioavailability and pharmacokinetic comparison of calcium glucoheptonate with calcium carbonate.

机构信息

Department of Pharmacology and Therapeutics, Faculty of Medicine, University of Indonesia, Jakarta, Indonesia.

PT Pharma Metric Labs, Jakarta, Indonesia.

出版信息

Pharmacol Res Perspect. 2020 Apr;8(2):e00589. doi: 10.1002/prp2.589.

Abstract

Adequate calcium intake is important for the prevention of bone loss and osteoporosis. For some populations such as those of Southeast Asia where calcium intake is very low, supplements represent a suitable dietary source of calcium. The objective of this study was to compare the relative oral bioavailability of calcium from calcium glucoheptonate, a highly soluble calcium salt containing 8.2% of elemental calcium, to that of calcium carbonate. A single-dose, randomized-sequence, open-label, two-period crossover study, with a 7-day washout period, was conducted in 24 Indonesian healthy adult volunteers. After a 12-hour (overnight) fast, subjects received either two oral ampoules of 250 mg/10 mL of calcium glucoheptonate each or one effervescent tablet of calcium carbonate containing 500 mg of elemental calcium. The relative oral bioavailability of calcium from calcium glucoheptonate as compared to calcium carbonate was 92% within 6 hours and 89% within 12 hours after study drug administration. The 90% confidence intervals for the mean test/reference ratios of the maximum plasma concentration and the area under the concentration-time curve at 12 hours post-administration were 77.09%-120.31% and 60.58%-122.30%, respectively. Five subjects experienced a total of eight adverse events which were all mild and transient; no serious adverse events or deaths were reported. These results indicate that calcium glucoheptonate is associated with a high relative bioavailability of calcium compared to calcium carbonate, and is well-tolerated. Calcium glucoheptonate might thus be a potential choice for calcium supplementation in Southeast Asian populations.

摘要

摄入足够的钙对于预防骨质流失和骨质疏松症很重要。对于一些钙摄入量非常低的人群,如东南亚人群,补充剂是一种合适的钙源。本研究的目的是比较葡萄糖酸钙(一种含有 8.2%元素钙的高水溶性钙盐)和碳酸钙的相对口服生物利用度。这是一项单剂量、随机、序列、开放标签、两周期交叉研究,洗脱期为 7 天,在 24 名印度尼西亚健康成年志愿者中进行。禁食 12 小时(过夜)后,受试者分别服用 2 支 250mg/10ml 的葡萄糖酸钙安瓿或 1 片含有 500mg 元素钙的碳酸钙泡腾片。葡萄糖酸钙的相对口服生物利用度与碳酸钙相比,在给药后 6 小时内为 92%,12 小时内为 89%。给药后 12 小时时,最大血浆浓度和浓度-时间曲线下面积的测试/参考比值的 90%置信区间分别为 77.09%-120.31%和 60.58%-122.30%。5 名受试者共发生 8 起不良事件,均为轻度且短暂;未报告严重不良事件或死亡。这些结果表明,与碳酸钙相比,葡萄糖酸钙的钙相对生物利用度较高,且耐受性良好。因此,葡萄糖酸钙可能是东南亚人群补钙的一种潜在选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5e61/7164401/15db0eafbb13/PRP2-8-e00589-g001.jpg

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