Studies of the Toxicological Potential of Capsinoids: X. Safety Assessment and Pharmacokinetics of Capsinoids in Healthy Male Volunteers after a Single Oral Ingestion of CH-19 Sweet Extract
Studies of the Toxicological Potential of Capsinoids: X. Safety Assessment and Pharmacokinetics of Capsinoids in Healthy Male Volunteers after a Single Oral Ingestion of CH-19 Sweet Extract
复制标题
DOI：
10.1080/10915810802514476
复制
发表时间：
2008-01-01
影响因子：
2.2
通讯作者：
Mihara, Ryuichi
中科院分区：
文献类型：
--
作者：
Bernard, Bruce K.;Tsubuku, Shoji;Mihara, Ryuichi
在16名健康男性志愿者单次口服CH-19甜提取物后，研究了CH-19甜提取物的生理活性成分辣椒素的安全性和药代动力学。研究对象服用含有辣椒素（15或30毫克/人）或安慰剂的软凝胶胶囊。辣椒素耐受性良好，在15或30 mg剂量下，体格检查、血压、心率、体温、心电图、血液学、血液化学和尿液分析均无临床显著变化。摄入辣椒素后体温有升高的趋势，但仍保持在正常范围内。血浆中辣椒素及其代谢物香草醇的含量低于定量下限。此外，一些研究对象尿中3-甲氧基-4-羟基苯基乙二醇的排泄量增加，与接受安慰剂的组相比，没有达到统计学意义。
The safety and pharmacokinetics of capsinoids, physiologically active ingredients of CH-19 Sweet extract, were investigated in 16 healthy male volunteers following a single oral ingestion of CH-19 Sweet extract. The study subjects consumed soft gel capsules containing either capsinoids (15 or 30 mg/person) or placebo. Capsinoids were well tolerated, and no clinically significant changes in physical examinations, blood pressure, heart rate, body temperature, electrocardiogram, hematology, blood chemistry, and urinalysis were observed at either the 15 or 30 mg dose. Body temperature tended to increase after the ingestion of capsinoids, but remained within the normal range. Plasma levels of capsinoids and their metabolite, vanillyl alcohol, were below the lower limit of quantitation. In addition, some study subjects showed increases in urinary excretion of 3-methoxy-4-hydroxyphenylglycol that, when compared to the group receiving the placebo, did not achieve statistical significance.