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ТОКСИКОЛОГІЧНА ХАРАКТЕРИСТИКА КОМБІНОВАНОГО ПРЕПАРАТУ НА ОСНОВІ ТЕОБОНУ-ДИТІОМІКОЦИДУ І ГЕНТАМІЦИН СУЛЬФАТУ
Authors: ОМЕЛЬЧУК С.Т., ШКАРАПУТА Л.М., ПЕЛЬО І.М., ТИЩЕНКО Л.О., СТЕПАНЕНКО В.І., ЦЕХМІСТЕР Я.В., ШЕВЧЕНКО Л.О., БЛАГАЯ А.В.
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Mycosises Treatment (fungal infections), despite the great achievements in the study of the etiology and pathogenesis, remains today a challenge, which leads to the search for new effective and safe medicinal substances.
Objective: assessment of the potential risk of side adverse effects on the basis of a combined teobon-dithiomycocide and gentamicin preparation for the treatment of fungal infections of the skin.
Methods. Studied compositions were containing various concentrations of teobon-dithiomycocide and gentamicin sulfate (Gentamicin).
Study of acute oral toxicity was conducted on Wistar rats of both sexes by injection to the food using a metal probe. Skin-resorptive effect was studied on rats of the same strain, guinea pigs and rabbits by applying a drug solution and ointment with 24 hours exposure. Irritant effect on skin and mucous membranes was studied in rabbits by application of 0.5 ml of the preparation to the clipped skin under semiocclusive dressing and instillation of 0.1 ml of the preparation in the conjunctival sac of the eye, followed by assessment of the results. Allergic properties have been studied in guinea pigs. Cumulative properties were studied in rats for 2 months by administration of the preparation to the stomach at 135 mg/kg dose daily, and by simultaneous application on the skin at 300 mg/kg dose. The dynamics of animals’ behavior, food consumption and water intake were evaluated, body weight was recorded, and the state of the cardiovascular system, external respiration, central nervous system, haematological, biochemical, histological and macroscopic (skin) parameters were studied.
Results. It was established that combined antimycotic, containing teobon-dithiomycocide and gentamicin sulfate active substances, is low toxicity for white mice and rats when administered into the stomach, and when applied on the skin in mice, rats, rabbits and guinea pigs. At the studied concentrations (with a maximum of 5% teobon-dithiomycocide and 0.1% gentamicin sulfate) preparation does not irritate the skin and does not damage the structure of the skin and subcutaneous tissues, as shown by histological studies. Allergic properties of the drug have not been revealed. Cumulative properties when administered into the stomach and simultaneously applied to the skin were not expressed.
Conclusions. In the experiment carried out taking into account the conditions of use in medical practice, it was found that the studied preparation in aqueous solutions and petrolatum-based ointments is non-irritating to the skin and mucous membranes, has no adverse effect on the cardiovascular, respiratory, central nervous systems, the morphological composition of the blood, liver and kidney function and structure.