SOME ASPECTS OF PRE-CLINICAL STUDY OF SAFETY OF THE LYCOPUS EUROPAEUS L. DRY EXTRACT

Relevance. Currently used medicine drugs are quite effective, but with prolonged use can cause serious side effects. Recently, there has been con-siderable interest in the use of herbal drugs that can influence the functional activity and structure of the thyroid gland. One of the promising objects, based on which scientific research is conducted, is the Lycopus europaeus L. (Lamiaceae), which has a thyroostatic effect. The purpose. To evaluate the general toxic effect of the dry extract of Lycopus europaeus L. during prolonged introduction to rats to determine the prospects of creating a new thyrotropic drug on its basis. Material and methods. A chronic experiment has conducted on male and female Wistar rats in accordance with the “Guidelines for conducting pre-clinical studies of drugs”. Dry extract of Lycopus europaeus L. in the form of freshly prepared 1%, 5% and 10% aqueous suspensions haveintroducted into stomach for 90 days at doses of 50, 250 and 750 mg / kg. The integral health indicators of experimental animals have recorded, peripheral blood samples have taken to determine hematological and biochemical parameters, the functional state of the cardiovascular system (ECG study) has stud-ied, the excretory function of the kidneys has compared with 3% of the water load; study of the central nervous system - according to indicative reac-tions in the test "open field". At the end of the experiment, histological studies of the internal organs of experimental animals have performed. Results. Introduction the dry extract of Lycopus europaeus L. to the stomach of clinically healthy rats of both sexes fora long time at doses of 50, 250, 750 mg / kg. had a sedative effect, as well as a dose-dependent hypothyroid effect has shown. Prolonged introduction of the studied extract in 40- and 125-fold therapeutic doses (250 and 750 mg / kg) caused a moderate toxic effect on the liver and tubular apparatus of the kidneys. The threshold dose is set to 50 mg / kg. Conclusion. The results of the studies made a new thyroid-stimulating drug of systemic action (0.200 g capsules), based on the extract studied, and recommend it for conducting clinical studies, observing the therapeutic dose and caution for use in patients with liver and kidney diseases.