toxreviewТоксикологический вестникToxicological Review0869-79223034-4611Federal Scientific Center of Hygiene named after F.F. Erisman10.47470/0869-7922-2025-33-6-448-456fnjzzntoxreview-1040Research ArticleПРОФИЛАКТИЧЕСКАЯ ТОКСИКОЛОГИЯPREVENTIVE TOXICOLOGYСовременные подходы к гигиеническому нормированию фармацевтических субстанций в воздухе рабочей зоны (обзор литературы)Modern approaches to hygienic regulation of pharmaceutical substances in the air of the working area (literature review)https://orcid.org/0000-0001-7319-5337ХамидулинаХалидя ХизбулаевнаKhamidulinaKhalidya Kh.

Доктор мед. наук, профессор, главный научный сотрудник, руководитель НИАЦ РПОХБВ ФБУН «ФНЦГ им. Ф.Ф. Эрисмана» Роспотребнадзора, 121087, Москва, Российская Федерация; заведующий кафедрой гигиены ФГБОУ ДПО РМАНПО Минздрава России

e-mail: Khamidulina.KhKh@fncg.ru

Doctor of Medical Sciences, Professor, Chief Researcher, Head of the Scientific Information and Analytical Center “Russian Register of Potentially Hazardous Chemical and Biological Substances” of the F.F. Erisman Federal Scientific Center of Hygiene, Rospotrebnadzor, Moscow, 121087, Russian Federation; Professor, Head of the Department of Hygiene, Russian Medical Academy of Continuous Professional Education, RF Ministry of Health, Moscow, 125993, Russian Federation

e-mail: Khamidulina.KhKh@fncg.ru

Khamidulina.KhKh@fncg.ruhttps://orcid.org/0000-0002-4020-3123ТарасоваЕлена ВладимировнаTarasovaElena V.

Кандидат хим. наук, старший научный сотрудник, заместитель руководителя НИАЦ РПОХБВ ФБУН «ФНЦГ им. Ф.Ф. Эрисмана» Роспотребнадзора, 121087, Москва, Российская Федерация

e-mail: tarasova.ev@fncg.ru

Candidate of Chemical Sciences, Senior Researcher, Deputy Head of the Scientific Information and Analytical Center “Russian Register of Potentially Hazardous Chemical and Biological Substances” of the F.F. Erisman Federal Scientific Center of Hygiene, Rospotrebnadzor, Moscow, 121087, Russian Federation

e-mail: tarasova.ev@fncg.ru

tarasova.ev@fncg.ruhttps://orcid.org/0009-0001-9233-7430БалашовПётр ЕвгеньевичBalashovPeter E.

Специалист организационно-методического отдела НИАЦ РПОХБВ ФБУН «ФНЦГ им. Ф.Ф. Эрисмана» Роспотребнадзора, 121087, Москва, Российская Федерация

e-mail: Balashov.PE@fncg.ru

Specialist at the Organizational and Methodological Department of the Scientific Information and Analytical Center “Russian Register of Potentially Hazardous Chemical and Biological Substances” of the F.F. Erisman Federal Scientific Center of Hygiene, Rospotrebnadzor, Moscow, 121087, Russian Federation

e-mail: Balashov.PE@fncg.ru

Balashov.PE@fncg.ruНаучный информационно-аналитический центр «Российский регистр потенциально опасных химических и биологических веществ» ФБУН «Федеральный научный центр гигиены им. Ф.Ф. Эрисмана» Роспотребнадзора; ФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Минздрава РоссииРоссияScientific Information and Analytical Center “Russian Register of Potentially Hazardous Chemical and Biological Substances” of the F.F. Erisman Federal Scientific Center of Hygiene, Rospotrebnadzor; Russian Medical Academy of Continuous Professional Education, RF Ministry of HealthRussian FederationНаучный информационно-аналитический центр «Российский регистр потенциально опасных химических и биологических веществ» ФБУН «Федеральный научный центр гигиены им. Ф.Ф. Эрисмана» РоспотребнадзораРоссияScientific Information and Analytical Center “Russian Register of Potentially Hazardous Chemical and Biological Substances” of the F.F. Erisman Federal Scientific Center of Hygiene, RospotrebnadzorRussian FederationНаучный информационно-аналитический центр «Российский регистр потенциально опасных химических и биологических веществ» ФБУН «Федеральный научный центр гигиены им. Ф.Ф. Эрисмана» Роспотребнадзора; ФГАОУ ВО Первый Московский государственный медицинский университет имени И.М. Сеченова Министерства здравоохранения Российской Федерации (Сеченовский Университет)РоссияScientific Information and Analytical Center “Russian Register of Potentially Hazardous Chemical and Biological Substances” of the F.F. Erisman Federal Scientific Center of Hygiene, Rospotrebnadzor; I.M. Sechenov First Moscow State Medical University, Ministry of Health of the Russian FederationRussian Federation202522012026336448456Copyright © Хамидулина Х.Х., Тарасова Е.В., Балашов П.Е., 20262026Хамидулина Х.Х., Тарасова Е.В., Балашов П.Е.Khamidulina K.K., Tarasova E.V., Balashov P.E.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.toxreview.ru/jour/article/view/1040

Достижение лекарственной независимости Российской Федерации за счёт локального производства по полному производственному циклу на территории страны стратегически значимых лекарственных средств требует обеспечения безопасности работающих, занятых в фармацевтическом производстве, что невозможно без современных подходов к гигиеническому нормированию фармацевтических субстанций в воздухе рабочей зоны.

Цель работы – выявить перспективные направления актуализации существующей нормативно-методической базы в области гигиенического нормирования фармацевтических субстанций в воздухе рабочей зоны.

В работе представлен анализ отечественной и зарубежной литературы, содержащей сведения о международных и национальных подходах к нормированию фармацевтических субстанций в воздухе рабочей зоны.

Современные подходы к гигиеническому нормированию фармацевтических субстанций основаны на использовании в качестве точек отсчёта максимальных недействующих и реперных доз (концентраций) с учётом различных коэффициентов запаса, применении методов фармакокинетического моделирования для экстраполяции данных исследований пероральной токсичности на ингаляционную, машинного обучения для прогноза свойств химических веществ, оценке канцерогенного риска при нормировании генотоксикантов прямого действия, а также на установлении нормативов для вспомогательных веществ лекарственных средств и учёте биологической активности действующих веществ, являющихся аналогами эндогенно синтезируемых субстанций.

Нормативно-методическая база гигиенического нормирования фармацевтических субстанций в воздухе рабочей зоны требует актуализации с учётом новых подходов. Наиболее перспективными представляются использование реперных доз в качестве точек отсчёта при обосновании безопасных уровней воздействия и фармакокинетического моделирования.

Участие авторов

Участие авторов. Все соавторы внесли равнозначный вклад в исследование и подготовку статьи к публикации.

Конфликт интересов

Конфликт интересов. Авторы заявляют об отсутствии явных и потенциальных конфликтов интересов в связи с публикацией данной статьи.

Финансирование

Финансирование. Исследование финансируется в рамках НИР «Совершенствование методологии гигиенического нормирования фармацевтических субстанций (лекарственных средств) в воздухе рабочей зоны, атмосферном воздухе населённых мест и воде водных объектов» по отраслевой программе «Гигиена» Роспотребнадзора.

Поступила в редакцию

Поступила в редакцию: 22 ноября 2025 / Принята в печать: 25 ноября 2025 / Опубликована: 15 января 2026

Drug independence of the Russian Federation requires the presence of full-cycle enterprises of strategically important medicines and, consequently, the safety of workers, which is impossible without modern approaches to the hygienic regulation of pharmaceutical substances in the air of the working area.

The purpose of the study was to identify prospective areas for updating the existing regulatory and methodological framework in the hygienic regulation of pharmaceutical substances in the air of the working area.

The article presents an analysis of domestic and foreign literature containing information on international and national approaches to the regulation of pharmaceutical substances in the air of the working area.

Modern approaches to hygienic regulation of pharmaceutical substances based on the use of NOAEL (no observed adverse effective level) and BMD (benchmark dose) as points of departure taking into account different safety factors, the use of pharmacokinetic modeling methods to extrapolate data from oral toxicity studies to inhalation, machine learning to predict the properties of chemicals, assessment of carcinogenic risk when rationing direct-acting genotoxicants, as well as on the establishment of standards for excipients of medicinal products and account for the biological activity of active substances that are analogues of endogenously synthesized substances.

The regulatory and methodological framework for hygienic regulation of pharmaceutical substances in the air of the working area requires updating, taking into account new approaches. The most promising is the use of NOAEL and BMD as reference points in the justification of safe exposure levels, and pharmacokinetic modeling.

Authors’ contribution

Authors’ contribution: All co-authors have made an equal contribution to the research and preparation of the article for publication.

Conflict of interests

Conflict of interests. The authors declare no apparent and potential conflicts of interest in relation to the publication of this article.

Funding

Funding. The study is funded as part of the research project “Methodology development of the hygienic regulation of pharmaceutical substances in the air of the working area, the atmospheric air of populated areas and the water of water bodies” of the Rospotrebnadzor sector program “Hygiene”.

Received

Received: November 22, 2025 / Accepted: November 25, 2025 / Published: January 15, 2026

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The authors declare that there are no conflicts of interest present.