toxreviewТоксикологический вестникToxicological Review0869-79223034-4611Federal Scientific Center of Hygiene named after F.F. Erisman10.47470/0869-7922-2026-34-3-199-213cajeaytoxreview-1112Research ArticleПРОФИЛАКТИЧЕСКАЯ ТОКСИКОЛОГИЯPREVENTIVE TOXICOLOGYПодходы к дезактивации цитостатических препаратов: деградация, минерализация и токсикологическая верификация (обзор литературы)Approaches to the deactivation of cytostatic drugs: degradation, mineralization, and toxicological assessment (literature review)https://orcid.org/0000-0001-7319-5337ХамидулинаХалидя ХизбулаевнаKhamidulinaKhalidya Kh.

Доктор медицинских наук, главный научный сотрудник; руководитель Научного информационно-аналитического центра РПОХБВ ФБУН «ФНЦГ им. Ф.Ф. Эрисмана» Роспотребнадзора, 121087, Москва, Россия; профессор, заведующая кафедрой гигиены ФГБОУ ДПО РМАНПО Минздрава России, 125993, Москва, Россия

e-mail: khalidiya@yandex.ru

Doctor of Medical Sciences, 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: khalidiya@yandex.ru

khalidiya@yandex.ruhttps://orcid.org/0000-0002-4020-3123ТарасоваЕлена ВладимировнаTarasovaElena V.

Кандидат химических наук, старший научный сотрудник, зам. руководителя Научного информационно-аналитического центра РПОХБВ ФБУН «ФНЦГ им. Ф.Ф. Эрисмана» Роспотребнадзора, 121087, Москва, Россия

e-mail: tarasova.ev@fncg.ru

Candidate of Chemical Sciences, Senior Research, 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/0000-0002-2327-9353КурпединовКирилл СергеевичKurpedinovKirill S.

Химик-эксперт, научный сотрудник Научного информационно-аналитического центра РПОХБВ ФБУН «ФНЦГ им. Ф.Ф. Эрисмана» Роспотребнадзора, 121087, Москва, Россия

e-mail: kurpedinov.ks@fncg.ru

Expert Chemist, Researcher 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: kurpedinov.ks@fncg.ru

kurpedinov.ks@fncg.ruhttps://orcid.org/0000-0003-0178-4540НазаренкоАндрей КонстантиновичNazarenkoAndrey K.

Химик-эксперт, младший научный сотрудник Научного информационно-аналитического центра РПОХБВ ФБУН «ФНЦГ им. Ф.Ф. Эрисмана» Роспотребнадзора, 121087, Москва, Россия

e-mail: Nazarenko.AK@fncg.ru

Expert Chemist, Junior Researcher 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: Nazarenko.AK@fncg.ru

Nazarenko.AK@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 Federation202630062026343199213Copyright © Хамидулина Х.Х., Тарасова Е.В., Курпединов К.С., Назаренко А.К., 20262026Хамидулина Х.Х., Тарасова Е.В., Курпединов К.С., Назаренко А.К.Khamidulina K.K., Tarasova E.V., Kurpedinov K.S., Nazarenko A.K.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/1112Введение

Введение. Цитостатические препараты широко применяются в онкологической практике, однако обращение с ними связано с риском профессионального и экологического воздействия. В Российской Федерации требования к обращению с медицинскими отходами, образующимися при применении цитостатических и иных опасных лекарственных препаратов, определяются Федеральными законами № 52-ФЗ «О санитарно-эпидемиологическом благополучии населения», № 89-ФЗ «Об отходах производства и потребления», № 323-ФЗ «Об основах охраны здоровья граждан в Российской Федерации», а также санитарными правилами СанПиН 2.1.3684–21, регламентирующими санитарно-эпидемиологические требования к обращению с отходами и предусматривающими необходимость их обезвреживания.

Вместе с тем, действующие нормативно-методические документы Российской Федерации регламентируют преимущественно организационные и санитарно-эпидемиологические аспекты обращения с такими отходами, но не содержат научно-обоснованных критериев выбора методов дезактивации и/или четких инструкций в зависимости от химической природы веществ и продуктов их трансформации, что создает определенные трудности у практических служб и контрольно-надзорных органов в реализации положений санитарного законодательства Российской Федерации.

Цель исследования – обобщить данные о современных подходах к дезактивации цитостатических препаратов с учетом оценки их эффективности, ограничений и полноты химико-аналитического и токсикологического подтверждения отсутствия опасных свойств после деградации.

Материалы и методы

Материалы и методы. Проведён анализ научных публикаций, нормативно-методических документов, международных руководств по обращению с опасными лекарственными препаратами, а также данных открытых научных баз PubMed, Scopus, Web of Science, eLIBRARY.RU, РИНЦ и КиберЛенинка. При анализе учитывали химическую природу препарата, метод дезактивации, степень деградации исходного вещества, данные об идентификации продуктов трансформации, показатели минерализации, результаты оценки мутагенности, цитотоксичности и экотоксичности.

Результаты

Результаты. Цитостатические препараты относятся к токсикологически значимой группе лекарственных средств, отдельные представители которой оказывают негативное воздействие на эндокринную систему человека и животных и/или отнесены экспертным сообществом к канцерогенам, мутагенам и репротоксикантам 1-го класса опасности. При этом как российские, так и международные нормативно-методические документы содержат существенные пробелы в вопросах их дезактивации.

Современные подходы включают окислительные, фотохимические, фотокаталитические, электрохимические методы и комплексообразование. Выбор подходящего метода определяется химическим строением исходного вещества, составом матрицы, условиями воздействия и свойствами образующихся продуктов трансформации.

Оценка эффективности подхода к дезактивации лекарственных препаратов должна включать следующие этапы: выбор подходящего метода деградации, химико-аналитическую оценку степени деградации исходного вещества и идентификацию продуктов трансформации, оценку степени минерализации, токсичности продуктов деградации, интерпретацию полученных результатов.

Ограничения исследования

Ограничения исследования. Исследование ограничено анализом открытых литературных, нормативно-методических и руководящих источников. В работу не включали закрытые производственные данные, неопубликованные отчёты, а также собственную экспериментальную проверку эффективности методов дезактивации. Сопоставимость данных была ограничена различиями в составе матриц, концентрациях цитостатических препаратов, условиях обработки и полноте химико-токсикологической оценки продуктов трансформации.

Заключение

Заключение. Принимая во внимание широкое использование цитостатических препаратов в медицинской практике, их токсичность и опасность, в том числе в составе отходов, целесообразным является разработка и внедрение в нормативно-методическую базу Российской Федерации документов (методических указаний и руководств), содержащих критерии выбора надлежащих методов дезактивации, списки рекомендуемых методов, методик и реагентов.

Участие авторов

Участие авторов: Хамидулина Х.Х., Тарасова Е.В. – концепция и дизайн исследования, редактирование, утверждение окончательного варианта статьи, ответственность за целостность всех её частей; Курпединов К.С., Назаренко А.К. – сбор и обработка материала, написание текста, редактирование.

Конфликт интересов

Конфликт интересов. Авторы декларируют отсутствие явных и потенциальных конфликтов интересов в связи с публикацией данной статьи.

Финансирование

Финансирование. Исследование не имело спонсорской поддержки.

Поступила в редакцию

Поступила в редакцию: 20 мая 2026 / Принята в печать: 01 июня 2026 / Опубликована: 30 июня 2026

Introduction

Introduction. Cytostatic drugs are widely used in oncology practice; however, their handling is associated with occupational and environmental exposure risks. In the Russian Federation, requirements for the management of medical waste generated during the use of cytostatic and other hazardous medicinal products are established by Federal Laws No. 52-FZ “On the Sanitary and Epidemiological Welfare of the Population”, No. 89-FZ “On Production and Consumption Waste”, and No. 323-FZ “On the Fundamentals of Public Health Protection in the Russian Federation”, as well as by Sanitary Rules SanPiN 2.1.3684–21, which regulate sanitary and epidemiological requirements for waste management and provide for the need for its decontamination.

At the same time, the current regulatory and methodological documents of the Russian Federation mainly regulate the organizational, sanitary and epidemiological aspects of handling such waste, but do not contain scientifically justified criteria for selecting deactivation methods and/or clear instructions depending on the chemical nature of the substances and their transformation products. This creates certain difficulties for practical services, control and supervisory authorities in implementing the provisions of the sanitary legislation of the Russian Federation.

The purpose of the study was to summarize data on current approaches to the deactivation of cytostatic drugs, taking into account the assessment of their effectiveness, limitations, and the completeness of chemical-analytical and toxicological evidence confirming the absence of hazardous properties after degradation.

Materials and methods

Materials and methods. A review of scientific publications, regulatory and methodological documents, international guidelines on the handling of hazardous medicinal products, and materials indexed in the open scientific databases PubMed, Scopus, Web of Science, eLIBRARY.RU, RSCI and CyberLeninka was conducted. The analysis took into account the chemical nature of the drug, the deactivation method, the degree of degradation of the parent compound, data on the identification of transformation products, mineralization parameters, and the results of mutagenicity, cytotoxicity and ecotoxicity assessments.

Results

Results. Cytostatic drugs represent a toxicologically significant group of drugs; some of their representatives adversely affect the endocrine system in humans and animals and are classified by the expert community as carcinogens, mutagens and reproductive toxicants of hazard category 1. At the same time, both Russian and international regulatory and methodological documents contain substantial gaps regarding their deactivation.

Current approaches include oxidative, photochemical, photocatalytic and electrochemical methods, as well as complexation. The choice of an appropriate method is determined by the chemical structure of the parent compound, the composition of the matrix, treatment conditions and the properties of the resulting transformation products.

Assessment of the effectiveness of an approach to the deactivation of medicinal products should include the following stages: selection of an appropriate degradation method, chemical-analytical assessment of the degree of parent compound degradation and identification of transformation products, assessment of mineralization degree, evaluation of the toxicity of degradation products, and interpretation of the results obtained.

Limitations

Limitations. The study was limited to the analysis of open literature, regulatory, methodological and guidance sources. Closed industrial data, unpublished reports and original experimental verification of the effectiveness of deactivation methods were not included. Data comparability was limited by differences in matrix composition, cytostatic drug concentrations, treatment conditions and the completeness of chemical and toxicological assessment of transformation products.

Conclusion

Conclusion. Taking into account the widespread use of cytostatic drugs in medical practice, as well as their toxicity and hazard, including when present in waste, it appears appropriate to develop and incorporate into the regulatory and methodological framework of the Russian Federation documents, including methodological guidelines and guidance documents, that contain criteria for selecting appropriate deactivation methods, as well as lists of recommended methods, procedures and reagents.

Authors’ contribution

Authors’ contribution: Khamidulina Kh.Kh.,Tarasova E.V. – concept and design of the study, editing, approval of the final version of the article, responsibility for the integrity of all parts of the article; Kurpedinov K.S., Nazarenko A.K. – collecting and processing material, writing text, editing.

Conflict of interest

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

Funding

Funding. The study had no sponsorship.

Received

Received: March 20, 2026 / Accepted: June 1, 2026 / Published: June 30, 2026

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