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Introduction. The working conditions of pharmaceutical industry workers are characterized by the combined effect of unfavorable factors of the production environment, among which the leading one is chemical. The aim of study is to substantiate the basic principles and criteria for hygienic regulation of pharmaceutical products in their production to ensure safe working conditions for employees based on the results of their own research and existing requirements of technical regulations. Materials and methods. Analysis of working conditions and the prevalence of health disorders in pharmaceutical workers (according to literature data), toxicological studies of pharmaceutical substances on laboratory animals, scientific justification of hygiene standards in the air of the working area. Results. Among employees of the pharmaceutical industry, the predominant forms of production-related health disorders are diseases of the respiratory system, as well as skin dermatitis of allergic origin, liver and biliary tract diseases. Based on the results of experimental studies of domestic pharmaceutical products for the treatment of cardiovascular, oncological and mental diseases that have priority socio-economic significance, the basic principles and features of the practice of justifying the hygienic standards of medicines in the air of the working area are developed and systematized. Conclusions. During hygienic rationing of medicines, it is necessary to use a differentiated approach that allows, based on the analysis of information about the chemical structure, physical and chemical characteristics, production conditions, pharmacotherapeutic activity, and the results of studying the toxic effect in an experiment on laboratory animals, to determine the maximum permissible content in the air of the working area of medicines or to justify the prohibition of isolation with reasoned recommendations for their safe production.

В эксперименте на животных изучена острая токсичность гидрозоля наночастиц серебра, стабилизированных пектином (нанокомпозит пектин-Ag), предварительно синтезированного и очищенного в соответствии с принципами «зеленой химии». Определены параметры острой токсичности при различных путях поступления нанокомпозита в организм (внутрижелудочном, внутрибрюшинном и ингаляционном). На основании полученных результатов проведена классификация нанокомпозита пектин-Ag по степени опасности, дана характеристика видовой чувствительности, изучено кожно-раздражающее, резорбтивное и ирритативное действие. A series of experimental studies was been performed on animal models for evaluating acute toxicity of silver nanoparticle-based hydrosol stabilized by pectin (pectin-Ag nanocomposite), which had been previously synthesized and purified in accordance with green chemistry principles. The parameters of acute toxicity were determined for multiple routes of nanocomposite administration (i.e. intragastric, intraperitoneal, and inhalation). The results obtained made it possible to classify the pectin-Ag nanocomposite for hazard degree. In addition, species sensitivity was characterized, and skin-irritating, resorptive and irritative effect was studied.

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