Farsi Elham, Esmailli Kameh, Shafaei Armaghan, Moradi Khaniabadi Pegah, Al Hindi Bassel, Khadeer Ahamed Mohamed B, Sandai Doblin, Abdul Sattar Munavvar, Ismail Zhari, Abdul Majid Amin Malik Shah, Abdul Majid Aman Shah
a School of Pharmaceutical Sciences , Universiti Sains Malaysia , Penang , Malaysia .
c School of Physics , Universiti Sains Malaysia , Penang , Malaysia .
Drug Chem Toxicol. 2016 Oct;39(4):461-73. doi: 10.3109/01480545.2016.1157810. Epub 2016 Apr 1.
Clinacanthus nutans (CN) is used traditionally for treating various illnesses. Robust safety data to support its use is lacking.
To evaluate the adverse effects of aqueous extract of CN leaves (AECNL).
The oral toxicity of the AECNL was tested following Organisation for Economic Co-operation and Development (OECD) guidelines. Mutagenicity (Ames test) of AECNL was evaluated using TA98 and TA100 Salmonella typhimurium strains.
No mortality or morbidity was found in the animals upon single and repeated dose administration. However, significant body weight loss was observed at 2000 mg/kg during sub-chronic (90 d) exposure. In addition, increased eosinophil at 500 mg/kg and decreased serum alkaline phosphatase levels at 2000 mg/kg were observed in male rats. Variations in glucose and lipid profiles in treated groups were also observed compared to control. Ames test revealed no evidence of mutagenic or carcinogenic effects at 500 μg/well of AECNL.
The median lethal dose (LD50) of the AECNL is >5000 mg/kg and the no-observed-adverse-effect level is identified to be greater than 2000 mg/kg/day in 90-d study.
传统上，鳄嘴花用于治疗各种疾病。目前缺乏有力的安全性数据来支持其使用。
评估鳄嘴花叶水提取物（AECNL）的不良反应。
按照经济合作与发展组织（OECD）指南测试AECNL的经口毒性。使用鼠伤寒沙门氏菌TA98和TA100菌株评估AECNL的致突变性（艾姆斯试验）。
单次和重复给药后动物未出现死亡或发病情况。然而，在亚慢性（90天）暴露期间，2000mg/kg剂量时观察到明显的体重减轻。此外，在雄性大鼠中，500mg/kg剂量时嗜酸性粒细胞增加，2000mg/kg剂量时血清碱性磷酸酶水平降低。与对照组相比，处理组的血糖和血脂水平也出现了变化。艾姆斯试验显示，在500μg/孔的AECNL剂量下，没有致突变或致癌作用的证据。
在90天的研究中，AECNL的半数致死剂量（LD50）>5000mg/kg，未观察到不良反应的水平确定为大于2000mg/kg/天。
