薬理と治療

Abstract

VENETRON(R) is a commercial botanical product made from the leaves of Apocynum venetum L. It contains flavonoids, with the main functional components being hyperoside and isoquercitrin. The safety of VENETRON(R) were evaluated in animals and human clinical trials. Briefly, the 50％ lethal dose of VENETRON(R) was determined to be greater than 2000mg╱kg body weight in an acute oral toxicity study of mice. An 8-week subchronic toxicity study in rats revealed the no-observed-adverse-effect-level for VENETRON(R) to be at least 250 mg╱kg body weight╱day. Drug interaction testing indicated that VENETRON(R) did not influence cytochrome P450 3A or P-glycoprotein in rats. Furthermore, 30 healthy volunteers in Japan participated in a safety study, ingesting 50mg╱day for weeks 1-8, followed by 150mg╱day for weeks 9-12. No adverse effects resulted from taking VENETRON(R), and biochemical parameters remained within the reference ranges. Also through a placebo-controlled study with 17 healthy volunteers in Japan, ingesting 50 mg╱day for 8 days, showed no adverse effects from taking VENETRON(R). In addition, an 8-week study of 50 mg VENETRON(R)╱day was also conducted in 39 individuals in Canada, the UK, and the USA. The adverse events and blood pressure records indicated no difference between the VENETRON(R) and placebo groups. These results demonstrate the safety of VENETRON(R) and provide overall support for the potential of VENETRON(R) in various health-related applications.