Neuropharmacology Research Laboratory, Department of Pharmaceutics, Institute of Technology, Banaras Hindu University, Varanasi 221 005, Uttar Pradesh, India.
J Ethnopharmacol. 2011 Apr 12;134(3):992-5. doi: 10.1016/j.jep.2011.01.045. Epub 2011 Feb 1.
Despite Fumaria indica (FI) widespread medicinal uses in the Indian traditional medicine, no systematic study of the potential toxicity of the plant has been described.
To assess acute and sub-chronic toxicity of a 50% ethanolic extract of FI in mice and rats respectively.
In acute toxicity study, Swiss strain albino mice of either sex were administered orally FI doses of 1, 2.5 and 5 g/kg and observed for behavioural changes and mortality, if any. In sub-chronic toxicity study, Charles Foster albino rats of either sex were administered two doses of FI i.e., 100 and 400mg/kg, p.o. for 30 consecutive days. During 30 days of treatment, rats were observed for any change in body weight and daily food and water intake. After 30 days, rats were sacrificed for haematological, biochemical and histopathology study. Control animals were administered 0.3% carboxymethyl cellulose (CMC) suspension by oral route.
There was no mortality or abnormal behaviour, observed in acute toxicity study in mice at all the three dose levels. In sub-chronic toxicity study, FI did not produce any significant change in body weight and daily food and water intake of rats when compared to vehicle treated rats. Further, haematological and biochemical parameters were also found normal. Histopathological study revealed normal architecture of kidney and liver of FI treated rats.
FI extract, provisionally standardized on its fumarate contents, seems to fulfill a preclinical criterion necessary for its further development as a clinically useful adaptogen.
尽管印度传统医学中广泛使用了 Fumaria indica(FI),但尚未对该植物的潜在毒性进行系统研究。
分别在小鼠和大鼠中评估 FI 的 50%乙醇提取物的急性和亚慢性毒性。
在急性毒性研究中,给雄性和雌性瑞士白化病小鼠口服 FI 剂量为 1、2.5 和 5 g/kg,并观察任何行为变化和死亡情况。在亚慢性毒性研究中,雄性和雌性 Charles Foster 白化病大鼠分别给予 FI 两个剂量,即 100 和 400mg/kg,po,连续 30 天。在 30 天的治疗期间,观察大鼠的体重和每日食物和水摄入量是否有任何变化。30 天后,对大鼠进行血液学、生化学和组织病理学研究。对照动物通过口服给予 0.3%羧甲基纤维素(CMC)悬浮液。
在所有三个剂量水平下,FI 在急性毒性研究的小鼠中均未引起死亡或异常行为。在亚慢性毒性研究中,FI 未使大鼠的体重和每日食物和水摄入量与 vehicle 处理的大鼠相比产生任何显著变化。此外,血液学和生化参数也正常。组织病理学研究显示 FI 处理的大鼠的肾脏和肝脏结构正常。
FI 提取物,临时根据其富马酸盐含量进行标准化,似乎符合进一步开发为临床有用的适应原所需的临床前标准。