Department of Pharmacology of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 100102, China; Department of Biomedicine Science, College of Medicine, University of Toledo, Toledo 43614, United States.
Department of Pharmacology of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 100102, China.
Regul Toxicol Pharmacol. 2014 Apr;68(3):370-7. doi: 10.1016/j.yrtph.2014.01.007. Epub 2014 Jan 29.
The aim of this study was to investigate the acute and sub-chronic toxicity of extract of Thunberg Fritillary Bulb. For the acute toxicity tests, graded doses of the extract were administered orally to mice. The animals were observed for toxic symptoms and mortality daily for 14days. In the sub-chronic toxicity study, rats were orally administered the extract at doses of 1 and 3mg/kg body weight (BW) for 26weeks. After 26weeks, the rats were sacrificed for hematological, biochemical and histological examination. In the acute toxicity tests, the estimated median lethal dosage (LD50) was 52.2mg/kg body weight in the mice. In the sub-chronic toxicity tests, a dose of 1mg/kg body weight presented no toxicity. Above the 1mg/kg dose, the main adverse signs observed in male rats were body or head tremor and spontaneous motor activity reduction. There were no other significant changes observed in hematology, blood biochemistry, organ weight and organ histology. The overall findings of this study indicate that the extract of Thunberg Fritillary Bulb is non-toxic up to 1mg/kg body weight, which can be considered a safe application dose.
本研究旨在探讨百合科贝母属植物浙贝母提取物的急性和亚慢性毒性。在急性毒性试验中，采用不同剂量的提取物对小鼠进行灌胃，每日观察动物的毒性症状和死亡率，共 14 天。在亚慢性毒性试验中，大鼠以 1mg/kg 和 3mg/kg 的剂量连续灌胃给药 26 周。26 周后处死大鼠，进行血液学、生化学和组织学检查。在急性毒性试验中，估计浙贝母提取物在小鼠中的半数致死剂量（LD50）为 52.2mg/kg 体重。在亚慢性毒性试验中，1mg/kg 体重剂量组未见毒性。高于 1mg/kg 体重剂量组时，雄性大鼠的主要不良体征为身体或头部震颤和自发运动活性减少。血液学、血液生化学、器官重量和器官组织学未见其他明显变化。本研究的总体结果表明，浙贝母提取物的无毒剂量高达 1mg/kg 体重，可以认为是安全的应用剂量。
