DOI: https://doi.org/10.22263/2312-4156.2025.4.91
V.O. Zemtsova, R.V. Bogdanov, V.V. Shevlyakov, V.A. Filonyuk, I.S. Poznyak
Justification of the criteria for rationing and the maximum permissible concentration in the working area air of antibacterial drugs on the example of the pharmaceutical substance clindamycin hydrochloride
Research Institute of Hygiene, Toxicology, Epidemiology, Virology and Microbiology of the State Institution “Republican Center of Hygiene, Epidemiology and Public Health”, Minsk, Republic of Belarus
Vestnik VGMU. 2025;24(4):91-99.
Abstract.
Objectives. To substantiate analytically the criteria and principles of hygienic regulation of the content of antibacterial drugs in the air of the working area with their testing on the example of the pharmaceutical substance of the antibiotic clindamycin hydrochloride.
Results. By the analysis of methodological documents on the development of maximum permissible concentration in the air of the working zone (MРCw.z.) of different types of industrial substances we have substantiated the criteria for standardization of antibacterial drugs (ABD) by the nature of their leading harmful effect on the body depending on the quantitative prevalence of the values of threshold concentrations of general toxic or specific allergic and/or dysbiotic action established in chronic inhalation experiments; the procedure for calculating the safety factor to the established value of the threshold concentration of chronic toxicity of ABD when substantiating MРCw.z. has been clarified as well.
Conclusions. The standardization of the pharmaceutical substance clindamycin hydrochloride (CH) according to the limiting criterion of the leading harmful general toxic effect on the body is shown; the MРCw.z. of CH aerosol according to the established value of the threshold concentration of chronic general toxic effect (Limсh at the level of 4.4 mg/m3) is substantiated taking into account the calculated safety factor (11) at the level of 0.4 mg/m3, hazard class II
Keywords: antibacterial drugs, pharmaceutical substance clindamycin hydrochloride, the working area air, safety factor, hygienic standardization criteria, hygienic standardization principles.
The sources of funding. The work was carried out within the framework of the subprogram “Safety of the Human Habitat” of the State Scientific and Technical Program “Scientific and Technical Support for the Quality and Availability of Medical Services” for 2021-2025, the task 03.10 “To develop a method for hygienic standardization of antibacterial drugs in the air of the working area”, state registration number 20221232.
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Submitted 05.05.2025
Accepted 22.08.2025
Information about authors:
Violetta O. Zemtsova – postgraduate student, research fellow of the industrial toxicology laboratory of the Research Institute of Hygiene, Toxicology, Epidemiology, Virology and Microbiology of the Republican Center of Hygiene, Epidemiology and Public Health, https://orcid.org/0009-0009-2048-6398, e-mail: Этот адрес электронной почты защищён от спам-ботов. У вас должен быть включен JavaScript для просмотра.;
R.V. Bogdanov – Candidate of medical sciences, head of the industrial toxicology laboratory of the Research Institute of Hygiene, Toxicology, Epidemiology, Virology and Microbiology of the Republican Center of Hygiene, Epidemiology and Public Health, https://orcid.org/0000-0003-3655-4155
V.V. Shevlyakov – Doctor of medical sciences, professor, chief researcher of the industrial toxicology laboratory of the Research Institute of Hygiene, Toxicology, Epidemiology, Virology and Microbiology of the Republican Center of Hygiene, Epidemiology and Public Health, https://orcid.org/0000-0001-8226-9350
V.A. Filonyuk – Doctor of medical sciences, professor, chief researcher of the industrial toxicology laboratory of the Research Institute of Hygiene, Toxicology, Epidemiology, Virology and Microbiology of the state institution “Republican Center of Hygiene, Epidemiology and Public Health”, https://orcid.org/0009-0002-5617-6593
I.S. Poznyak – Candidate of biological sciences, head of the department for ensuring the reliability of test results of the Research Institute of Hygiene, Toxicology, Epidemiology, Virology and Microbiology of the Republican Center of Hygiene, Epidemiology and Public Health.
