Acute and sub-acute oral toxicity assessment of formulation containing hydroethanolic extract of morninga oleifera, vernonia amygdalina, centella asiatica leaves in mice

Abstract

Pharmacological effects of Moringa oleifera leaves, Vernonia amygdalina leaves, Centella asiatica, and their combination have been proven in experimental studies. However, evidence for the safety of this combination has not been reported. This study was conducted to evaluate the safety of formulation comprising three herbal extracts M. oleifera, V. amygdalina and C.asiatica in Swiss albino mice. The test was conducted according to Guideline for testing of chemicals OECD 423, 407 and Ministry of Health guidelines Vietnam (decision number 141/QĐK2ĐT, October 27, 2015). For acute toxicity, both sexes of Swiss albino mice were given as a single dose at the highest possible concentration through a needle. Their behavior changes, adverse effects and mortality were observed in 72 hours and periodically in 14 days. After evaluating acute toxicity, the number of tested mice remained stable and they showed no bizarre difference in behavior, fur, eating and urination with a Dmax dose of 16.13 g/kg. For sub – acute toxicity, mice were received the combinated extract at doses of 400 mg/kg and 800 mg/kg for 56 consecutive days. Any signs of fatality, body change or attitude were recorded. Body weights, biochemical parameters and hematological analysis were monitored before, after 4 weeks and at the end of experiment. After finishing the experiments, histopathological changes were detected in some vital organs. Sub – acute toxicity evaluation revealed no mortality, body or behavior changes. Most of biochemical, hematological parameters were in accepted scope. Heart tissues were all normal; however, liver and kidney were histopathological difference. The results showed that the extract has no acute oral toxicity and has ambiguous subchronic toxicity, indicating that the extract could be considered safe for oral medication