Abstract

EVALUATION OF SAFETY OF ARIFLEX TABLET - A POLYHERBAL FORMULATION IN SPRAGUE DAWLEY RATS

Vasant E. Narke*, Nitin V. Athavale, Ujwala V. Khisti, Sanjay U. Nipanikar

Abstract

Objectives: Ayurvedic plants are known for many years to have antiinflammatory and anti-arthritic effects. Ariflex tablet is a polyherbal formulation intended for treatment of osteoarthritis, rheumatoid arthritis, gout, lumbago, sciatica, spondylitis etc., Acute and repeated dose 90-days studies were conducted to evaluate the safety profile of Ariflex tablet in rats. Materials and Methods: In acute study, Ariflex tablet was finely powdered, suspended in water and then administered orally to Sprague Dawley rats at 2000 mg/kg. In repeated dose study, Ariflex tablet was administered to rats at 250, 500 and 1000 mg/kg by oral gavage for 90 days and assessed for treatment related changes in body weight, feed consumption, hematological, biochemical and pathological parameters. Histopathological examination was conducted for tissues from control and the high dose groups and was extended to target organs from the lower dose, intermediate dose and recovery groups. Results: In acute study, the test item did not produce any mortality or adverse clinical signs. In the 90-days oral toxicity study, animals did not exhibit any toxicity related symptoms and no mortality was observed. No significant changes were found in hematological and biochemical parameters. Also, significant abnormal changes were not observed in relative organ weights. Even microscopic findings did not show any changes when compared with control group animals and animals in recovery group. Conclusions: Based on the findings of the study, the median lethal dose of Ariflex tablet was found to be more than 2000 mg/kg. The No Observed Adverse Effect Level (NOAEL) of Ariflex tablet can be considered as 1000 mg/kg in both male and female rats, under the experimental conditions and doses employed. The results suggest that Ariflex tablet is well tolerated antiarthritic formulation.

Keywords: Acute, polyherbal, sub chronic, toxicity, Ariflex tablet.