Department of Pharmacology and Toxicology, R&D Centre, Natural Remedies Pvt Ltd, 5B, Veerasandra Industrial Area, 19th KM Stone, Hosur Road, Near Electronic City, Bangalore 560 100, India.
Int J Toxicol. 2009 Jul-Aug;28(4):308-17. doi: 10.1177/1091581809339631.
The possible effect of extract of Andrographis paniculata Nees (A paniculata) standardized to >or=10% andrographolide, the main bioactive component, on male fertility in albino Wistar rats was evaluated, by orally administering 0, 20, 200, and 1000 mg/kg of body weight per day, for 65 days prior to mating and 21 days during mating. The treated groups showed no signs of dose-dependent toxicity. The body weight gain and feed consumption were not affected at any of the dose levels. The testosterone levels and fertility indices in treatment groups were found to be comparable with that of the control indicating no effect on fertility. Total sperm count and sperm motility were not affected. The testes and epididymides did not show any gross and histopathological changes. Based on these findings, it can be concluded that the no-observed adverse effect level of extract of A paniculata (>or=10% andrographolide) was found to be more than 1000 mg/kg per day.
评估了按叶穿心莲（穿心莲）提取物，其标准化为 >or=10% 的穿心莲内酯，为主要生物活性成分，对雄性生育力的可能影响。按叶穿心莲提取物以 0、20、200 和 1000 mg/kg 体重剂量每天口服给予，在交配前 65 天和交配期间 21 天进行给药。处理组没有表现出剂量依赖性毒性的迹象。在任何剂量水平，体重增加和饲料消耗都没有受到影响。处理组的睾丸激素水平和生育指数与对照组相当，表明对生育力没有影响。精子总数和精子活力不受影响。睾丸和附睾没有显示出任何明显的宏观和组织病理学变化。基于这些发现，可以得出结论，穿心莲提取物（>or=10% 穿心莲内酯）的未观察到不良反应水平大于每天 1000 mg/kg。
