Safety Evaluation of BF001, an Anti-diabetic Herbal Preparation in Sprague-Dawley Rats

Background : "BF001" is a herbal preparation made from the leaves of Bridelia ferruginea. Despite its prolonged use in treating diabetes mellitus, there is no empirical evidence of its safety as a hypoglycaemic agent. Objectives : This study evaluated the acute and chronic toxicity of 'BF001' with the view to determining the LD50 and toxic effects on specific organs after prolonged administration in male Spraque-Dawley rats. -1 Methods : Acute toxicity was carried out within 14 days; a single high dose of 5000 mg kg body weight was administered orally to a group of 8 rats to determine LD . Chronic toxicity was also carried out over a period of 6 50 -1 -1 months (180 days) at the normal therapeutic dose level (41 mg kg ) and ten times the normal dose (410 mg kg ). Results: There were no significant differences found in most of the haematological, urine chemistry, serum biochemical parameters and relative organ weight. It, however, caused a significant decrease in pentobarbitone -1 induced sleeping time. The oral LD of 'BF001' is above 5000 mg kg body weight. 50 Conclusion : 'BF001' had no overt organ specific toxicity but may modulate the production and/or the activity of certain microsomal monooxygenases which may lead to drug-drug interactions if the test preparation is taken concurrently with other medicinal preparations. Keywords : Toxicity, Bridelia ferruginea, rodents, diabeties