Noguchi-Shinohara Moeko, Ono Kenjiro, Hamaguchi Tsuyoshi, Iwasa Kazuo, Nagai Toshitada, Kobayashi Shoko, Nakamura Hiroyuki, Yamada Masahito
Department of Neurology and Neurobiology of Aging, Kanazawa University Graduate School of Medical Sciences, Kanazawa, Japan.
Department of Food and Life-Science, Takasaki University of Health and Welfare, Gunma, Japan.
PLoS One. 2015 May 15;10(5):e0126422. doi: 10.1371/journal.pone.0126422. eCollection 2015.
The aim of this study was to evaluate the safety, tolerability and pharmacokinetics of single dose of Melissa officinalis extract which contained rosmarinic acid, including food-effects in healthy individuals. A total of eleven healthy individuals were randomly assigned to treatment arms in the two studies [Study 1 (fasted state) and Study 2 (fed state)]. Rosmarinic acid in serum was measured by a coulometric detection method using High-Performance Liquid Chromatography electrochemical detector. The serum concentration of total rosmarinic acid peaked at 1 hour after administration of Melissa officinalis extract containing 500mg rosmarinic acid in fasted state, with a maximum serum concentration 162.20 nmol/ L. The area under the curve for intact rosmarinic acid was calculated from the serum concentration-time profile to be 832.13 nmol • hour/ L. Food intake increases area under the curve and delayed time at which the maximum serum concentration. Rosmarinic acid supplementation did not affect liver, kidney, or blood cell function parameters. No adverse event was reported by any of the participants due to the study treatment. Single dose of Melissa officinalis extract containing 500 mg rosmarinic acid appears to be safe and tolerable in healthy individuals. Food intake increased the exposure of rosmarinic acid and delayed absorption of rosmarinic acid in healthy individuals.
本研究旨在评估单剂量含有迷迭香酸的蜜蜂花提取物的安全性、耐受性和药代动力学，包括在健康个体中的食物效应。在两项研究[研究1（空腹状态）和研究2（进食状态）]中，共有11名健康个体被随机分配至各治疗组。血清中的迷迭香酸采用高效液相色谱电化学检测器的库仑检测法进行测定。在空腹状态下，给予含有500mg迷迭香酸的蜜蜂花提取物后，总迷迭香酸的血清浓度在给药后1小时达到峰值，最大血清浓度为162.20nmol/L。根据血清浓度-时间曲线计算出完整迷迭香酸的曲线下面积为832.13nmol•小时/L。食物摄入增加了曲线下面积，并延迟了最大血清浓度出现的时间。补充迷迭香酸未影响肝脏、肾脏或血细胞功能参数。没有任何参与者因本研究治疗报告不良事件。单剂量含有500mg迷迭香酸的蜜蜂花提取物在健康个体中似乎是安全且可耐受的。食物摄入增加了健康个体中迷迭香酸的暴露量并延迟了迷迭香酸的吸收。
