SUB-ACUTE TOXICITY STUDY OF DIABECINE RECONSTITUTE IN SPRAGUE-DAWLEY RATS: A PRELIMINARY STUDY IN THE EVALUATION AS AN ANTIHYPERGLYCEMIA AGENT

Abstract

Diabecine reconstitute is a combination of well-known herbs such as Cinnamomum zeylanicum, Eugenia polyantha, Curcuma xanthorizza, Orthosiphon stamineus and Andrographis paniculata which are believed to give promising finding especially in the treatment of diabetes mellitus. However, no scientific studies have been performed to investigate its toxicological effect. Therefore, this study aimed to evaluate its safety profile using sub-acute toxicity (14 days repeated doses) in rat model. The sub-acute toxicity study was evaluated by daily administration of different doses (250, 600 and 2000 mg/kg) of diabecine reconstitute for 14 days. Clinical signs, body weight changes, food and water intake, white blood count and relative organ weight were recorded. While the liver and kidney were removed for histological analysis. The result indicated that administration of diabecine reconstitute did not show significant differences in food consumption, water intake and white blood count (p>0.05) as compared to the control. However, there is significant difference observed in body weight and relative organ weight (p<0.05). Diabecine reconstitute at 600 and 2000 mg/kg proved to be toxic to kidney and liver in histopathology studies. However, the diabecine reconstitute at concentration of 250 mg/kg is safe to be used and showed no toxicity effect. Therefore, diabecine reconstitute at dose of 250 mg/kg was found to be toxicologically safe and it may be a good potential polyherbal formula to be incorporated in the diabetes mellitus treatment.