Acute and sub-acute toxicity studies on an antidiabetic polyherbal formulation in mice

Abstract

Purpose: To investigate the acute and sub-acute toxicity of an Indonesian polyherbal formulation in experimental mice. Methods: Young and healthy Swiss albino mice of both sexes (5 – 6 weeks old), weighing 24 – 25 g were used in this study. Acute toxicity test was conducted in the mice using OECD 425 method and AOT425StatPgm software to determine the polyherbal formulation’s lethal dose (LD50) value, while the sub-acute toxicity test was performed for 28 days using OECD 407 method, by measuring hematological and clinical biochemistry parameters, as well as examining the histology of the liver and kidneys. The acute toxicity test consisted of the following dose groups: 175, 550, 1750 and 5000 mg/kg, while sub-acute toxicity test dose groups were 200, 400 and 800 mg/kg. Each group consisted of 5 male and 5 female mice. Results: Based on the results obtained, LD50 value of the polyherbal formula was >5000 mg/kg. Repeated doses for 28 days showed significant differences (p < 0.05) for white blood cells (WBC) and platelet parameters in male mice, and for mean corpuscular volume (MCV), mean corpuscular hemoglobin concentration (MCHC), and platelet parameters in female mice. However, the values were within normal limits. With regard to clinical biochemical parameters - aspartate aminotransferase (AST), Alanine aminotransferase (ALT), blood urea nitrogen (BUN), creatinine, and albumin - there were no significant differences (p > 0.05) between the test groups. Furthermore, no changes were observed in their histological features. Conclusion: The evaluated polyherbal formulation can be considered safe for use in mice. However, clinical trials in diabetic patients at the proposed doses are required to ascertain the formulation’s safety profile.