ABSTRACT:
Herbal remedies are considered the oldest forms of healthcare known to mankind on this earth. Herbal formulations have attained extensive adequacy as therapeutic agent but, there are some confines regarding the safety. The present study investigated the acute and sub-acute toxicity of a novel anti-ulcer polyherbal formulation in experimental animal models. The herbal formulation used in this study consists of seven medicinal plants namely Aegle marmelos, Elettaria cardamomum, Glycyrrhiza glabra, Citrus aurantifolia, Rosa damascena, Cissus quadrangularis and Saccharum officinarum. In an acute toxicity study, PHF was administered orally at doses ranging from 5 – 2000mg/kg and the animals were observed for any toxic symptoms up to 72 hours. The results indicated there were no toxic symptoms up to the dose of 2000mg/kg of PHF in acute toxicity study. In sub-acute toxicity study, PHF was tested at the dose levels of 100, 200 and 400mg/kg, administered orally once daily for 28 days. Body weight, food intake and water intake were monitored at regular intervals. On 29th day blood was collected, subjected to hematological, liver function and kidney function tests. The animals were sacrificed, and the brain, heart, liver, spleen, kidney and testis were processed for histopathological study. The results of the 28 day sub-acute toxicity study did not show evidence of any changes in body weight, food intake, water intake, hematological parameters, liver and kidney function tests when compare to control animals. There were no remarkable changes noticed in the histopathological studies. Oral administration of the PHF at doses of 100, 200 and 400 mg/kg body weight, for 28 consecutive days to male and female Wistar rats did not induce any short-term toxicity. Collectively, these data demonstrate that the Polyherbal formulation have a high margin of drug safety.