Pharmacokinetics, Safety and Tolerability of Melissa officinalis Extract which Contained Rosmarinic Acid in Healthy Individuals: A Randomized Controlled Trial.
Pharmacokinetics, Safety and Tolerability of Melissa officinalis Extract which Contained Rosmarinic Acid in Healthy Individuals: A Randomized Controlled Trial.
复制标题
DOI：
10.1371/journal.pone.0126422
复制
发表时间：
2015
期刊：
影响因子：
3.7
通讯作者：
Yamada M
中科院分区：
文献类型：
--
作者：
Noguchi-Shinohara M;Ono K;Hamaguchi T;Iwasa K;Nagai T;Kobayashi S;Nakamura H;Yamada M
本研究的目的是评估单剂量含有迷迭香酸的香蜂草提取物的安全性、耐受性和药代动力学，包括健康个体的食物影响。在这两项研究中，共有 11 名健康个体被随机分配至治疗组 [研究 1（禁食状态）和研究 2（进食状态）]。使用高效液相色谱电化学检测器通过库仑检测法测定血清中的迷迭香酸。空腹状态下给予含有500mg迷迭香酸的香蜂草提取物后1小时，总迷迭香酸的血清浓度达到峰值，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的时间。补充迷迭香酸不会影响肝脏、肾脏或血细胞功能参数。任何参与者均未报告因研究治疗引起的不良事件。单剂量含有 500 毫克迷迭香酸的香蜂草提取物对于健康个体来说似乎是安全且可耐受的。食物摄入增加了健康个体迷迭香酸的暴露并延迟了迷迭香酸的吸收。试用注册：UMIN-CTR UMIN000004997
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. Trial Registration: UMIN-CTR UMIN000004997