Acute oral toxicity studies of the standardized methanolic extract of Phyllanthus amarus Schum & Thonn

Abstract

ObjectivesTo determine the acute toxicity of standardized methanolic extract of Phyllanthus amarus in vivo in female albino rats. MethodsTreated group of animals were administrated 300, 600, 2000 and 5000 mg/kg body weight of extract orally and the control group received standard laboratory diet and water ad libitum following OECD guideline 423 with some modifications. All animals were sacrificed after 14 days of treatment. ResultsThe extract was standardized by HPLC to contain phyllanthin and hypophyllanthin. No mortality was noted and the study exhibited no significant changes in general behavior, body weight, gross appearance of internal organs, hematological and biochemical parameters and the histological profile of liver also indicated the nontoxic nature of this drug. Biochemical studies showed no significant change in the levels of ALT, AST, albumin, triglycerides, cholesterol and albumin. There were no evidence found about congestion of sinusoids, hemorrhage, hepatocytes, fatty changes, centrilobular necrosis and the changes in number of Kupffer cells in the liver. There was no increase of blood pressure and does not induce any nephrotoxicity and acute severe hepatotoxicity. ConclusionThe present study provides pivotal evidences for ascertaining the safety of the standardized MEPA (LD50 > 5000 mg/kg) that could be used as tonic or food supplement in folklore medicine.