vedomostiregmedРегуляторные исследования и экспертиза лекарственных средствRegulatory Research and Medicine Evaluation3034-30623034-3453Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)10.30895/1991-2919-2025-15-2-190-205vedomostiregmed-700Research ArticleРАЗРАБОТКА ЛЕКАРСТВЕННЫХ СРЕДСТВ: ОТ ИДЕИ ДО ПРИМЕНЕНИЯPHARMACEUTICAL DEVELOPMENT: FROM AN IDEA TO THE FINAL P RODUCTРоль и безопасность вспомогательных веществ в лекарственной форме «сиропы»: обзорRole and Safety of Excipients in Syrups (Review)https://orcid.org/0000-0001-8353-7863КосенкоВ. В.KosenkoV. V.

Косенко Валентина Владимировна - канд. фарм. наук.

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

Valentina V. Kosenko - Cand. Sci. (Pharm.).

8/2 Petrovsky Blvd, Moscow 127051

https://orcid.org/0009-0005-2916-3756НовиковЯ. С.NovikovYa. S.

Новиков Ярослав Сергеевич

Ул. Бутлерова, д. 49, Казань, 420012

Yaroslav S. Novikov

49 Butlerov St., Kazan 420012

yaroslav.novikov@kazangmu.ruhttps://orcid.org/0000-0001-7671-3179ЕгороваС. Н.EgorovaS. N.

Егорова Светлана Николаевна - д-р фарм. наук, профессор.

Ул. Бутлерова, д. 49, Казань, 420012

Svetlana N. Egorova - Dr. Sci. (Pharm.), Professor.

49 Butlerov St., Kazan 420012

svetlana.egorova@kazangmu.ruhttps://orcid.org/0000-0002-6150-5796ЕвтеевВ. А.EvteevV. A.

Евтеев Владимир Александрович

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

Vladimir A. Evteev

8/2 Petrovsky Blvd, Moscow 127051

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

Бунятян Наталья Дмитриевна - д-р фарм. наук, профессор.

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

Natalya D. Bunyatyan - Dr. Sci. (Pharm.), Professor.

8/2 Petrovsky Blvd, Moscow 127051

ndbun@mail.ruФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииРоссияScientific Centre for Expert Evaluation of Medicinal ProductsRussian FederationФедеральное государственное бюджетное учреждение высшего образования «Казанский государственный медицинский университет» Министерства здравоохранения Российской ФедерацииРоссияKazan State Medical UniversityRussian FederationФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииРоссияScientific Centre for Expert Evaluation of Medicinal ProductsRussian Federation202501052025152190205Copyright © Косенко В.В., Новиков Я.С., Егорова С.Н., Евтеев В.А., Бунятян Н.Д., 20252025Косенко В.В., Новиков Я.С., Егорова С.Н., Евтеев В.А., Бунятян Н.Д.Kosenko V.V., Novikov Y.S., Egorova S.N., Evteev V.A., Bunyatyan N.D.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.vedomostincesmp.ru/jour/article/view/700ВВЕДЕНИЕ

ВВЕДЕНИЕ. Сиропы являются важной лекарственной формой (ЛФ), применяющейся в том числе в педиатрической практике (на январь 2024 года в Российской Федерации зарегистрировано 212 лекарственных препаратов в форме сиропов). Эффективность, безопасность и качество этой ЛФ определяются составом лекарственного препарата (ЛП), в том числе вспомогательными веществами (ВВ).

ЦЕЛЬ

ЦЕЛЬ. Анализ и систематизация данных о роли и безопасности вспомогательных веществ в составе лекарственной формы «сиропы», зарегистрированных в государственном реестре лекарственных средств Российской Федерации.

ОБСУЖДЕНИЕ

ОБСУЖДЕНИЕ. Рассмотрены основные группы ВВ, содержащихся в сиропах: подсластители, консерванты, растворители, загустители, модификаторы pH и буферные агенты, антиоксиданты и красители. Наиболее часто использующейся группой ВВ являются подсластители: сахароза (66,51%), сорбитол (29,25%), сахарин натрия (10,85%). Сахароза способствует развитию кариеса, а также противопоказана пациентам с сахарным диабетом и ожирением; сорбитол может вызывать желудочно-кишечные расстройства. Данные по безопасности искусственных подсластителей при длительном применении противоречивы, их выбор должен быть обоснован. Среди консервантов наиболее часто встречаются парабены: метилпарабен (31,60%) и пропилпарабен (20,28%). Пропилпарабен обладает потенциальной эстрогенной активностью, в связи с чем предпочтителен выбор метилпарабена. Растворители и сорастворители представлены водой, глицеролом (25,94%), этанолом (24,53%), пропиленгликолем (20,75%). Этанол и пропиленгликоль могут вызывать тяжелые нарушения со стороны центральной нервной системы. Наиболее часто используемым загустителем является гиэтеллоза (5,19%). Производные целлюлозы признаны безопасными, но их избыточное потребление может вызывать слабительный эффект. В качестве красителя наиболее часто применяется желтый «Солнечный закат» (7,54%). Данные по безопасности многих красителей недостаточны, что подчеркивает необходимость обоснованного подхода к их выбору.

ВЫВОДЫ

ВЫВОДЫ. На основании анализа инструкций по медицинскому применению сиропов, зарегистрированных в ГРЛС, систематизированы данные о роли, безопасности и допустимых количествах ВВ в сиропах. Дана классификация и рассчитана частота встречаемости ВВ, входящих в состав сиропов. На основе выявленных данных предложено пересмотреть существующие подходы к выбору ВВ в сиропах, чтобы минимизировать потенциальные риски и повысить безопасность ЛП.

INTRODUCTION

INTRODUCTION. Syrups are an important dosage form used in medical practice, particularly in paediatrics. As of January 2024, there are 212 medicinal products formulated as syrups approved in the Russian Federation. The effi­cacy, safety, and quality of syrups are determined by their composition, including excipients.

AIM

AIM. This study aimed to analyse and systematise data on the role and safety of excipients in syrups included in the Russian State Register of Medicines.

DISCUSSION

DISCUSSION. This article reviews the major groups of excipients present in syrups, including sweeteners, preservatives, solvents, thickeners, pH modifiers, buffering agents, antioxidants, and colourants. The most prevalent group of excipients is sweeteners, including sucrose (66.51%), sorbitol (29.25%), and sodium saccharin (10.85%). Sucrose contributes to tooth decay and is contraindicated in patients with diabetes and obesity. Sorbitol may cause gastrointestinal disorders. Data on the long-term safety of artificial sweeteners are contradictory. Therefore, sweeteners should be selected rationally. The most widely used preservatives are parabens, including methylparaben (31.60%) and propylparaben (20.28%). Propyl­paraben exhibits potential oestrogenic activity, which makes methylparaben the para­ben of choice. Solvents and co-solvents include water, glycerol (25.94%), ethanol (24.53%), and propylene glycol (20.75%). Ethanol and propylene glycol can cause severe central nervous system disorders. The most commonly used thickener is hydroxyethyl cellulose (5.19%). Cellulose derivatives are considered safe but may have a laxative effect if consumed in excess. The most popular colourant is Sunset Yellow (7.54%). The lack of data on the safety of many colourants emphasises the need for their rational selection.

CONCLUSIONS

CONCLUSIONS. By analysing summaries of product characteristics and patient information leaflets for syrups available in the Russian State Register of Medicines, the authors have systematised data on the role, safety, and acceptable daily intake of excipients in used syrups, classified these excipients, and calculated the frequency of their use. The findings suggest that the current approaches to selecting excipients for syrups should be revised to minimise potential risks and to enhance the safety of medicinal products.

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