ACUTE AND SUB ACUTE TOXICITY STUDIES OF STANDARDIZED EXTRACT BASED TAB PCOSBLESS IN RATS

Abstract

The present study investigated the acute and sub acute toxicity of Tab Pcosbless a standardized extract formulation developed for the management of Poly cystic ovarian syndrome (PCOS) in experimental animals. The raw materials were standardized by gravimetric, HPTLC, pH (1.0 % Solution), Loss on drying and Water soluble extractive methods for their respective bioactive marker compounds. In acute toxicity study, Tab Pcosbless was administered orally at doses 2000 mg/kg and the animals were observed for any toxic symptoms up to the period of 14 days. The results indicated there were no toxic symptoms seen at the dose level of 2000 mg/kg. In sub acute toxicity study, Tab Pcosbless was tested at the doses 500 mg/kg, 1000 mg/kg and 2000 mg/kg once daily for 28 days. The animals were sacrificed on the 29^th day and various blood biochemical parameters were measured. The liver, kidney, heart, spleen, testis (male), ovary (female), and lungs were processed for histopathological study. The results of the sub acute toxicity study did not show evidence of any abnormal changes in body weight, food intake, water intake, haematological parameters, liver function test (LFT), and renal function test (RFT) when compared with the normal animals. The female animals treated with formulation had prominent follicles developing in ovaries as observed in gross necropsy and histopathology. The vital organs of animals treated with Tab Pcosbless for 28 days did not show any histopathological evidence of pathological lesions. From the results it was concluded that Tab Pcosbless at the dose of 2000 mg/kg is safe for treatment in Poly cystic ovarian syndrome.