Preclinical safety evaluation of complex medicinal phytopreparations based on Saint-Mary thistle

A preclinical study of two complex phytopreparations based on Saint-Mary thistle (Silybum marianum) extract — sibektan (possessing hepatoprotective properties) and kamadol (producing antiinflammatory action) — has been carried out on various laboratory animals (male and female rats, mice, guinea pigs, rabbits, and dogs). The parent substances of both preparations have proved to be low-toxicity compounds for a single intragastric or intraperitoneal administration in mice, rats, and guinea pigs. The intragastric administration of sibektan parent substance in rats for 1 month in doses of 50, 500, and 1000 mg-kg also showed no significant toxicity. The intragastric administration of sibektan 0.1-g tablets in dogs for 4 months in doses of 20 and 200 mg-kg did not produce functional changes in the heart, liver, kidneys, blood, and nervous system of test animals. The intragastric administration of kamadol in rats in a dose of 10 ml-kg, in dogs in a dose of 3 ml-kg for 3 months, as well as the external application of kamadol oil in rabbits in a dose of 1 ml-kg for 3 months, did not produce general toxic and local irritant effects in animals. Kamadol did not cause specific long-term consequences (mutagen effect, allergic and immunotoxic reactions).