Monji Faezeh, Hossein Tehrani Hiva, Halvaei Zahra, Arbabi Bidgoli Sepideh
Young Researchers Club (YRC), Islamic Azad University, Pharmaceutical Sciences Branch (IAUPS), Tehran, Iran.
Acta Med Iran. 2011;49(12):769-75.
Stachys lavandulifolia is used as the herbal tea and its wide and potent medical effects have been reported for the extract in animal studies. This study aimed to find the safety profile of the extract to find the appropriate doses for further human studies. The aerial parts of the plant were air-dried and the hydroalcoholic extract was obtained and concentrated by percolation method with 140 mg/ml concentration. To assess the toxicity profile of this extract, 60 female mice (30 cases, 30 controls, 24.8 ± 2.1 g, 4-6 weeks) were administered the extract by oral gavages in acute (24 hrs), subacute (14 days) and subchronic (45 days) models. All clinical, hematological, biochemical and histopathological changes were assessed in appropriate midpoints and endpoints and compared with control group. Doses up to 140 mg⁄kg were recognized as maximum tolerated dose in subchronic model. Abnormal changes in kidney and liver weight in treatment groups as well as the significant elevation of biochemical parameters in 45 days study has suggested the possible hepatic and renal toxicity potentials of this extract with doses upper than 140 mg⁄kg. Doses up 70 mg⁄kg could be considered as no observable adverse effect level (NOAEL) and could be used in further clinical trials on the possible therapeutic effects of this plant.
水苏被用作草药茶，其提取物在动物研究中已被报道具有广泛而显著的医学功效。本研究旨在确定该提取物的安全性概况，以找到适合进一步人体研究的剂量。将该植物的地上部分风干，通过渗漉法获得水醇提取物并浓缩至浓度为140mg/ml。为了评估该提取物的毒性概况，在急性（24小时）、亚急性（14天）和亚慢性（45天）模型中，通过口服灌胃法给60只雌性小鼠（30只实验组，30只对照组，体重24.8±2.1g，4 - 6周龄）施用该提取物。在适当的中期和终点评估所有临床、血液学、生化和组织病理学变化，并与对照组进行比较。在亚慢性模型中，高达140mg/kg的剂量被认为是最大耐受剂量。治疗组肾脏和肝脏重量的异常变化以及45天研究中生化参数的显著升高表明，该提取物在剂量高于140mg/kg时可能具有肝脏和肾脏毒性潜力。70mg/kg以下的剂量可被视为无明显有害作用水平（NOAEL），可用于该植物可能的治疗效果的进一步临床试验。
