zldmЗаводская лаборатория. Диагностика материаловIndustrial laboratory. Diagnostics of materials1028-68612588-0187ООО «Издательство «ТЕСТ-ЗЛ»10.26896/1028-6861-2025-91-9-19-27zldm-2588Research ArticleАНАЛИЗ ВЕЩЕСТВАSUBSTANCES ANALYSISИсследование методом Тагучи ключевых факторов получения микросфер на основе сополимера молочной и гликолевой кислот для увеличения загрузки в них бетаметазона ацетатаTaguchi method-based optimization of key parameters for the preparation of poly(lactic-co-glycolic acid) microspheres to enhance betamethasone acetate loadingУльяноваЮ. В.UlianovaYu. V.

Юлия Вячеславовна Ульянова

125047, Москва, Миусская пл., д. 9

Yulia V. Ulianova

9, Miusskaya pl., Moscow, 125047

ulianova.i.v@muctr.ruВинокуровЕ. Г.VinokurovE. G.

Евгений Геннадьевич Винокуров

125047, Москва, Миусская пл., д. 9

119071, Москва, Ленинский просп., д. 31

125190, Москва, ул. Усиевича, д. 20

Evgeny G. Vinokurov

9, Miusskaya pl., Moscow, 125047

31, Leninsky prosp., Moscow, 119071

20, ul. Usievicha, Moscow, 125190

ЕрмоленкоЮ. В.ErmolenkoYu. V.

Юлия Валерьевна Ермоленко

125047, Москва, Миусская пл., д. 9

Yulia V. Ermolenko

9, Miusskaya pl., Moscow, 125047

МорозовА. Н.MorozovA. N.

Александр Николаевич Морозов

125047, Москва, Миусская пл., д. 9

Aleksandr N. Morozov

9, Miusskaya pl., Moscow, 125047

Российский химико-технологический университет им. Д. И. МенделееваРоссияMendeleev University of Chemical TechnologyRussian FederationРоссийский химико-технологический университет им. Д. И. Менделеева ; Институт физической химии и электрохимии им. А. Н. Фрумкина РАН ; Всероссийский институт научной и технической информации РАНРоссияMendeleev University of Chemical Technology ; Frumkin Institute of Physical Chemistry and Electrochemistry of the RAS ; All-Russian Institute for Scientific and Technical Information of the RASRussian Federation2025250920259191927Copyright © Ульянова Ю.В., Винокуров Е.Г., Ермоленко Ю.В., Морозов А.Н., 20252025Ульянова Ю.В., Винокуров Е.Г., Ермоленко Ю.В., Морозов А.Н.Ulianova Y.V., Vinokurov E.G., Ermolenko Y.V., Morozov A.N.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.zldm.ru/jour/article/view/2588

Изучено влияние основных технологических параметров на включение бетаметазона ацетата (БА) в полилактидные микросферы. Ключевые факторы, влияющие на характеристики микросфер, определяли методом Тагучи. В экспериментах варьировали различные параметры процесса получения микросфер: концентрацию полилактида, концентрацию БА, соотношение водной и органической фаз, скорость перемешивания. Установлено, что в наибольшей степени на увеличение загрузки БА влияют его концентрация и концентрация полилактида. Для определения бетаметазона ацетата использовали метод ВЭЖХ. Максимальная загрузка бетаметазона ацетата наблюдается при концентрациях полимера и бетаметазона ацетата 100 и 20 мг/мл соответственно, соотношении водной и органической фаз 50/1 и скорости перемешивания 500 об/мин. Загрузка бетаметазона ацетата в микросферы в оптимальных условиях составляет 4,35 % (до оптимизации — 1,44 %). Полученные результаты могут быть использованы для совершенствования методики получения полилактидных микросфер, «нагруженных» другими лекарственными веществами с похожими физико-химическими свойствами.

This study presents an investigation into the effects of key process parameters on the encapsulation of betamethasone acetate (BA) in poly(lactic-co-glycolic acid) (PLGA) microspheres. The Taguchi method was employed to identify the most influential factors affecting microsphere characteristics. The experimental design included variation of several parameters: PLGA concentration, BA concentration, the aqueous-to-organic phase ratio and stirring speed. The results indicate that BA loading is primarily influenced by its own concentration and the polymer concentration. High-performance liquid chromatography was used for determination of betamethasone acetate. Optimal loading was achieved at PLGA and drug concentrations of 100 and 20 mg/mL, respectively, an aqueous-to-organic phase ratio of 50:1, and a stirring speed of 500 rpm. Under these conditions, the drug loading reached 4.35%, compared to 1.44% prior to optimization. These findings may support the refinement of PLGA microsphere preparation techniques for other active pharmaceutical ingredients with similar physicochemical properties.

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