Preclinical investigation of the safety of the new hepatoprotective phytopreparation silymar

A preclinical study of the safety of silymar, a new phytopreparation from Saint-Mary thistle (Silybum marianum) fruits possessing hepatoprotector properties, has been carried out. The parent substance exhibited low general toxicity upon a single intragastric or intraperitoneal administration in both male and female rats and mice. The intragastric administration of silymar in rats for one month in a dose of 20, 200, and 2000 mg/kg showed evidence of a low chronic toxicity. Intragastric administration of silymar (0.1-g ready-to-use tablets) in dogs for three months in a dose of 100 mg/kg did not produce any significant changes of the heart, liver, kidneys, blood, and nervous system of the animals as indicated by the results of hematological, biochemical, and functional tests. As for specific toxicity manifestations, the intragastric administration of silymar in guinea pigs for one month in a dose of 10 and 50 mg/kg can lead to immediate allergic reactions.