Balogun Fatai Oladunni, Tom Ashafa Anofi Omotayo
Phytomedicine and Phytopharmacology Research Group, Department of Plant Sciences, University of the Free State, Qwaqwa Campus, Private Bag X13, Phuthaditjhaba, Free State 9866, South Africa.
Evid Based Complement Alternat Med. 2016;2016:3509323. doi: 10.1155/2016/3509323. Epub 2016 Apr 13.
The present study evaluated the safety of aqueous root extract of Dicoma anomala (AQRED) through acute and subchronic toxicity studies. Single oral dose of AQRED at the concentration of 0, 5, 300, and 2000 mg/kg as well as 125, 250, and 500 mg/kg/day was administered to rats for 14-day acute and 90-day subchronic oral toxicity studies. The results revealed no mortalities or observed clinical signs of toxicity in all the rats during both investigation periods. In subchronic toxicity testing, administration of AQRED also did not cause any changes in body weight as well as food and water consumption patterns. The haematological parameters and blood chemistry revealed no significant difference (p > 0.05) between the treatment and the control except in platelet count, alkaline phosphatase, and sodium levels where there was a significant increase (p < 0.05), although there was also a significant reduction (p < 0.05) in alanine transaminase, aspartate transaminase, and creatinine when compared to control. However, these changes were not reflecting the results from histology. Conclusively, the obtained results suggested that the LD50 of AQRED is in excess of 2000 mg/kg and its oral administration for 90 days revealed that it is unlikely to be toxic, hence, safe.
本研究通过急性和亚慢性毒性研究评估了异常双锥菊(AQRED)水根提取物的安全性。分别以0、5、300和2000mg/kg的浓度单次口服给予大鼠AQRED,以及以125、250和500mg/kg/天的剂量给予大鼠,进行为期14天的急性和90天的亚慢性口服毒性研究。结果显示,在两个研究期间,所有大鼠均无死亡或明显的毒性临床症状。在亚慢性毒性试验中,给予AQRED也未导致体重以及食物和水消耗模式发生任何变化。血液学参数和血液生化结果显示,除血小板计数、碱性磷酸酶和钠水平显著升高(p<0.05)外,治疗组与对照组之间无显著差异(p>0.05),不过与对照组相比,丙氨酸转氨酶、天冬氨酸转氨酶和肌酐也有显著降低(p<0.05)。然而,这些变化并未反映组织学结果。总之,所得结果表明,AQRED的半数致死剂量超过2000mg/kg,其90天的口服给药表明它不太可能有毒,因此是安全的。