Abstract

PRECLINICAL SAFETY EVALUATION OF VISHATHIRKU POORA MATHIRAI – A HERBO MINERAL DRUG

Dr. R. Palraj*, Dr. R. Madhavan and Dr. R. Meenakumari

ABSTRACT

The Herbo mineral formulation Vishathirku Poora Mathirai (VPM) has been used for treat many diseases like Toxic bites, fever and gastric ulcer. The aim of the present study was to evaluate the in-vivo toxicity of VPM. The acute and sub-chronic oral toxicity of VPM was evaluated in Wister albino rats. As an obligatory steps were taken to evaluate safety and efficacy of trial drug VPM. According to OECD guidelines, acute toxicity single dose of 5mg, 50mg, 300 mg and 2000 mg of VPM were administered, and monitor for 14 days. A single dose of 2000 mg/kg did not produce treatment related signs of toxicity or mortality in any of the animals tested during the 14-day observation period. Therefore, the LD 50 of this drug was estimated to be more than 2000 mg/kg. Sub-chronic toxicity studies were carried out in four groups of 20 animals (10 male & 10 female). The test drug VPM administered to rats for 90 days. After the study period the detailed hematological, biochemical, Histopathological evaluation of different organs was performed in all animals. Histopathological analysis revealed that the liver, lung, kidney, heart of treated groups did not show any signs of toxicity. Analyses of these results with the information of signs, behavior and health monitoring could lead to the conclusion that Acute and sub-chronic oral administration of VPM for 90 days does not cause toxicity.

Keywords: Vishathirku Poora Mathirai, Acute and sub-chronic, Herbomineral drug, Siddha.