Toxicological profile of the solid dosage form with microcapsules of Lycopus europaeus l.

Introdction.  Modern medicines for the treatment of thyroid diseases, along with their good effectiveness, can cause complications of hormonal and antithyroid therapy. In this regard, the search for new effective and safe medicines, including those of plant origin, remains relevant. One of the promising plants is Lycopus europaéus L. of the family Lamiaceae (Labiatae), on the basis of which VILAR has developed a solid dosage form in the form of capsules containing microcapsules of the extract of the herb European grasshopper.

The aim of the work was a retrospective analysis of the toxicological profile of the solid oral dosage form, comprising microencapsulated extract of Lýcopus europaéus herb, following repeated administration in rabbits.

Material and methods. The study focused on capsules containing microcapsulated extract from the herb of Lýcopus europaéus, packaged in 0-size capsules. A subchronic study was conducted using male rabbits of the «Soviet Chinchilla» breed. For 30 days, the capsules were administered orally at doses of 60 and 120 mg/kg. Throughout the study, integral health indicators of the experimental animals were monitored, peripheral blood samples were collected for hematological and biochemical analysis, an electrocardiogram was performed, and, at the conclusion of the study, a pathohistological examination of internal organs was conducted.

Results. The microcapsulated extract, in solid dosage form, at the tested doses, did not have a toxic effect on the major organs and body systems of rabbits. However, it did exhibit thyrostatic properties, leading to an increase in follicle size, filled with eosinophilic colloid and with overgrown cuboidal and squamous epithelial walls. The capsules were not irritating to the mucous membranes of the gastrointestinal tract in animals.

Conclusions. The findings suggest that a microencapsulated extract in capsule form may be recommended for clinical trials and submission for registration with the Russian Ministry of Health as a thyroid-suppressing medication.