pmedpharmФармация и фармакологияPharmacy & Pharmacology2307-92662413-2241Pyatigorsk Medical and Pharmaceutical Institute - branch of Volgograd State Medical Univer10.19163/2307-9266-2025-13-1-45-55pmedpharm-1672Research ArticleОРИГИНАЛЬНАЯ СТАТЬЯRESEARCH ARTICLEНормирование содержания йода в слоевищах ламинарии и продуктах на их основе: изменение подходов в рамках риск-ориентированной стратегии в контроле качества лекарственных средствRationing of iodine content in kelp layers and products based on them. Changing approaches within the framework of a risk-based strategyin drug quality controlhttps://orcid.org/0000-0001-9440-0950ЩукинВ. М.ShchukinV. M.

кандидат фармацевтических наук, главный эксперт лаборатории спектральных методов анализа ФГБУ «НЦЭСМП» Минздрава России. 

Россия, 127051, г. Москва, Петровский б-р, д. 8, стр. 2.

Candidate of Sciences (Pharmacy), Chief Scientist of the Laboratory of Spectral Analysis Methods of the Scientific Centre for Expert Evaluation of Medicinal Products. 

8 Petrovsky Blvd, Bldg 2, Moscow, Russia, 127051.

Schukin@expmed.ruhttps://orcid.org/0000-0002-9133-0835КузьминаН. Е.KuzminaN. E.

доктор химических наук, начальник лаборатории спектральных методов анализа ФГБУ «НЦЭСМП» Минздрава России. 

Россия, 127051, г. Москва, Петровский б-р, д. 8, стр. 2.

Doctor of Sciences (Chemistry), Head of the Laboratory of Spectral Analysis Methods of the Scientific Centre for Expert Evaluation of Medicinal Products. 

8 Petrovsky Blvd, Bldg 2, Moscow, Russia, 127051.

KuzminaN@expmed.ruhttps://orcid.org/0000-0002-4813-4740ХорольскаяЕ. А.KhorolskayaE. A.

эксперт 2 категории лаборатории спектральных методов анализа ФГБУ «НЦЭСМП» Минздрава России. 

Россия, 127051, г. Москва, Петровский б-р, д. 8, стр. 2.

Expert (Category 2) of the Laboratory of Spectral Analysis Methods of the Scientific Centre for Expert Evaluation of Medicinal Products.

8 Petrovsky Blvd, Bldg 2, Moscow, Russia, 127051.

blinkovaea@expmed.ruhttps://orcid.org/0000-0003-0936-5551БунятянН. Д.BunyatyanN. D.

доктор фармацевтических наук, профессор, ведущий научный сотрудник Научного отдела клинической фармакологии Института исследований и разработок ФГБУ «НЦЭСМП» Минздрава России. 

Россия, 127051, г. Москва, Петровский б-р, д. 8, стр. 2.

Doctor of Sciences (Pharmacy), Professor, Leading Researcher of the Scientific Department of Clinical Pharmacology of the Institute of Research and Development, Scientific Centre for Expert Evaluation of Medicinal Products. 

8 Petrovsky Blvd, Bldg 2, Moscow, Russia, 127051.

ndbun@mail.ruФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииРоссияScientific Centre for Expert Evaluation of Medicinal ProductsRussian Federation2025110720251314555Copyright © Щукин В.М., Кузьмина Н.Е., Хорольская Е.А., Бунятян Н.Д., 20252025Щукин В.М., Кузьмина Н.Е., Хорольская Е.А., Бунятян Н.Д.Shchukin V.M., Kuzmina N.E., Khorolskaya E.A., Bunyatyan N.D.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.pharmpharm.ru/jour/article/view/1672

В государственной фармакопее Российской Федерации нормируется нижний уровень содержания йода в слоевищах ламинарии. Однако переизбыток йода так же вреден для организма человека, как и его дефицит.

Цель

Цель. Определить диапазон допустимого содержания йода в лекарственном растительном сырье «Ламинарии слоевища» и продуктах на его основе в рамках риск-ориентированной стратегии в контроле качества лекарственных средств.

Материалы и методы

Материалы и методы. Были исследованы образцы лекарственных растительных препаратов, биологически активных добавок, пищевой продукции на основе слоевищ ламинарии различного происхождения, образцы водорослей, собранные авторами на побережье Белого моря и Тихого океана, а также литературные данные о содержании йода в фармакопейных видах. Содержание йода определяли методом масс-спектрометрии с индуктивно-связанной плазмой после экстракции по ГОСТ EN 15111-2015. Расчёт неканцерогенного риска проводили в соответствии с Руководством Р 2.1.10.1920-04.

Результаты

Результаты. Определено среднее (0,14%) и максимальное (0,46%) содержание йода в фармакопейных видах слоевищ ламинарии, которое соотносится нормой содержания йода в ламинариевых водорослях, предложенных Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США (U.S. Food and Drug Administration) — 0,1–0,5%. Установлено, что при максимальной терапевтической дозе и курсе лечения слабительными фитопрепаратами, при условии содержания йода в них 0,5%, уровень неканцерогенного риска попадает в категорию предельно допустимого. При аналогичных условиях лечение, например, мастопатии препаратами на основе слоевищ ламинарии с содержанием йода 0,5% приводит к недопустимому воздействию йода на здоровье человека.

Заключение

Заключение. Авторы рекомендуют вместо существующей нормы содержания йода (не менее 0,1%), принимать во внимание допустимое количество этого элемента (0,1–0,5%), которое соответствует его реальному содержанию в фармакопейных видах слоевищ ламинарии.

The State Pharmacopoeia of the Russian Federation regulates the lower level of iodine content in Laminaria thalli. However, an excess of iodine is as harmful to the human body as its deficiency.

The aim

The aim. To determine the range of permissible iodine content in the medicinal plant raw material "Laminaria thalli" and products based on it within the framework of a risk-oriented strategy in medicine quality control.

Materials and methods

Materials and methods. Samples of medicinal herbal preparations, biologically active additives, food products based on Laminaria thalli of various origins, samples of algae collected by the authors on the coast of the White Sea and the Pacific Ocean, as well as literature data on the iodine content in pharmacopoeial species were studied. The iodine content was determined by inductively coupled plasma mass spectrometry after extraction according to GOST EN 15111-2015. The non-carcinogenic risk was calculated in accordance with Guidance R 2.1.10.1920-04.

Results

Results. The average (0.14%) and maximum (0.46%) iodine content in pharmacopoeial species of Laminaria thalli was determined, which correlates with the iodine content norm in Laminaria algae proposed by the U.S. Food and Drug Administration (FDA) — 0.1–0.5%. It was found that at the maximum therapeutic dose and course of treatment with laxative herbal preparations, containing 0.5% of iodine, the level of non-carcinogenic risk falls into the category of maximum permissible. Under similar conditions, treatment, for example, of mastopathy with preparations based on Laminaria thalli with 0.5% of iodine leads to an unacceptable impact of iodine on human health.

Conclusion

Conclusion. The authors recommend, instead of the existing norm of iodine content (not less than 0.1%), to take into account the permissible amount of this element (0.1–0.5%), which corresponds to its real content in pharmacopoeial species of Laminaria thalli.

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