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DOI: https://doi.org/10.22263/2312-4156.2020.1.86

Adamenko G.V., Miklis N.I., Burak I.I.
Toxicological safety of ethanol containing medicinal agents for preventive antisepsis
Vitebsk State Order of Peoples’ Friendship Medical University, Vitebsk, Republic of Belarus

Vestnik VGMU. 2020;19(1):86-93.

Abstract.
The aim of this work was to study the toxicological safety indicators of the developed alcohol-containing medicinal agents «Vitasept» for prophylactic antisepsis.
4 series of experiments were performed on adult white male rats weighing 250±25 g kept in standard conditions. A single intragastric administration to rats of native antiseptics containing 72% ethanol of the brand de luxe with diamond green 0.001%, with crystalline iodine 0.25%, with chlorhexidine bigluconate 0.1%, as well as «Ethanol, solution for external use, 70%» at a dose of 5300 mg/kg of rat body weight does not cause the death of experimental animals. After a single 4-hour application at a dose of 20 mg/cm2 in a closed manner and ten times repeated applications on a sheared skin area, as well as rat tails after 1, 16 hours and in the next 12 days of observation after application, they do not cause the death of experimental animals, clinical symptoms of intoxication and skin irritation. All studied agents had a specific alcoholic smell, were transparent, genuine, with a density of 0.877 up to 0.885 g/cm3.
The results obtained allow us to conclude that the studied innovative medicinal antiseptic agents containing environmentally friendly 72% ethanol of the brand de luxe  with brilliant green 0.001%, with crystalline iodine 0.25%, with chlorhexidine bigluconate 0.5% and 0.1%, as well as original medicinal antiseptic agents containing environmentally friendly 72% ethanol of the brand de luxe with brilliant green 0.01%, with crystalline iodine 0.5%, are slightly hazardous, practically harmless and do not produce a skin-irritating effect. Currently developed alcohol-containing antiseptics, as well as products manufactured by «Bobruisk plant of biotechnologies» under the brand names «Vitasept-SKZ», «Vitasept-SKI» and «Vitasept-SKO», comply with the regulatory requirements for toxicological safety indicators of skin antiseptics, agents for hygienic and surgical treatment of hands, skin of the operative and injection fields.
Key words: antiseptic, «Vitasept», toxicological safety, ethanol, danger, skin-irritating effect, preventive antisepsis, brilliant green, сrystalline iodine, chlorhexidine bigluconate.

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Information about authors:
Adamenko G.V. – senior lecturer of the Chair of Organization & Economy of Pharmacy with the course of the Faculty for Advanced Training & Retraining, Vitebsk State Order of Peoples’ Friendship Medical University;
Miklis N.I. – Candidate of Medical Sciences, associate professor, head of the Chair of General Hygiene & Ecology, Vitebsk State Order of Peoples’ Friendship Medical University,
ORCID: https://orcid.org/0000-0002-7707-5882;
Burak I.I. – Doctor of Medical Sciences, professor of the Chair of General Hygiene & Ecology, Vitebsk State Order of Peoples’ Friendship Medical University,
ORCID: https://orcid.org/0000-0002-7204-3056.

Correspondence address: Republic of Belarus, 210009, Vitebsk, 27 Frunze ave., Vitebsk State Order of Peoples’ Friendship Medical University, Chair of Organization & Economy of Pharmacy with the course of the Faculty for Advanced Training & Retraining. E-mail: Этот адрес электронной почты защищён от спам-ботов. У вас должен быть включен JavaScript для просмотра. – Gennadiy V. Adamenko.

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