pmedpharmФармация и фармакологияPharmacy & Pharmacology2307-92662413-2241Pyatigorsk Medical and Pharmaceutical Institute - branch of Volgograd State Medical Univer10.19163/2307-9266-2021-9-6-441-453pmedpharm-978Research ArticleФАРМАЦЕВТИЧЕСКАЯ ТЕХНОЛОГИЯ И БИОТЕХНОЛОГИЯPHARMACEUTICAL TECHNOLOGY AND BIOTECHNOLOGYРАЗРАБОТКА ПЕРОРАЛЬНОЙ ЛЕКАРСТВЕННОЙ ФОРМЫ ГИПОЛИПИДЕМИЧЕСКОГО ДЕЙСТВИЯ НА ОСНОВЕ СУЛЬФАТИРОВАННОГО АРАБИНОГАЛАКТАНА В ВИДЕ КАЛИЕВОЙ СОЛИDEVELOPMENT OF PERORAL HYPOLIPIDEMIC FORMULATION BASED ON SULFATED ARABINOGALACTAN IN THE FORM OF POTASSIUM SALThttps://orcid.org/0000-0003-2660-4796КостыроЯ. А.KostyroYa. A.

кандидат фармацевтических наук, старший научный сотрудник группы фармацевтической разработки

yanakos@irioch.irk.ruhttps://orcid.org/0000-0002-8350-2158АлексеевК. В.AlekseevK. V.

доктор фармацевтических наук, профессор, главный научный сотрудник лаборатории готовых лекарственных форм 

Doctor of Sciences (Pharmacy), Professor, Chief Researcher of the Laboratory of finished dosage forms

alekseev@academpharm.ruФедеральное государственное бюджетное учреждение науки «Иркутский институт химии имени А.Е. Фаворского» Сибирского отделения Российской академии наук 664033, Россия, г. Иркутск, ул. Фаворского, д. 1РоссияFederal State Budget Institution for Science “A.E. Favorsky Irkutsk Institute of Chemistry Siberian Branch of the Russian Academy of Sciences” 1, Favorsky St., Irkutsk, Russia, 664033Russian FederationФедеральное государственное бюджетное научное учреждение «Научно-исследовательский институт фармакологии им. В.В. Закусова» 125315, Россия, г. Москва, ул. Балтийская, д.РоссияFederal State Budgetary Institution “Research Zakusov Institute of pharmacology” 8, Baltyskaya St., Moscow, Russia, 125315Russian Federation20210712202196441453Copyright © Костыро Я.А., Алексеев К.В., 20212021Костыро Я.А., Алексеев К.В.Kostyro Y.A., Alekseev K.V.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.pharmpharm.ru/jour/article/view/978

В Иркутском институте химии им. А.Е. Фаворского Сибирского отделения Российской академии наук разработан оригинальный гепариноид – сульфатированный арабиногалактан в виде калиевой соли, обладающий антикоагулянтной и гиполипидемической активностями.

Цель

Цель. Создание на основе сульфатированного арабиногалактана в виде калиевой соли твердых дозированных лекарственных форм для перорального применения в виде таблеток, покрытых пленочной оболочкой, и капсул для профилактики и лечения атеросклеротического повреждения кровеносных сосудов, которые в дальнейшем будут пригодны для клинического исследования.

Материалы и методы

Материалы и методы. Для получения твердых дозированных лекарственных форм использовались: сульфатированный арабиногалактан в виде калиевой соли, полученный в Иркутском институте химии им. А.Е. Фаворского СО РАН; Ludipress®; AEROSIL® 200 Pharma; кальция стеарат; Aquacoat ECD. Применялось брикетирование порошковых масс с последующим таблетированием и нанесением готового пленочного покрытия Aquacoat ECD и капсулирование в твердые желатиновые капсулы.

Результаты

Результаты. На основе изученных физико-химических и технологических свойств сульфатированного арабиногалактана в виде калиевой соли обоснован состав и технология производства таблеток, покрытых пленочной оболочкой, и капсул. Для разработанных твердых дозированных лекарственных форм определены технологические параметры и показатели качества в соответствии с требованиями Государственной фармакопеи РФ XIV издания.

Заключение

Заключение. Разработаны оптимальные составы и технологии получения таблеток, покрытых оболочкой, и капсул на основе сульфатированного арабиногалактана в виде калиевой соли для профилактики и лечения атеросклеротического повреждения кровеносных сосудов. Полученные данные положены в основу разработки нормативной документации.

An original heparinoid, sulfated arabinogalactan in the form of potassium salt, possessing anticoagulant and hypolipidemic activities, has been developed at  the A.E. Favorsky Irkutsk Institute of Chemistry Siberian Branch of the Russian Academy of Sciences.

The aim was to develop solid peroral dose forms (capsules and film-coated tablets) for the prevention and treatment of atherosclerotic lesion of blood vessels on the basis of potassium salt of sulfated arabinogalactan which would be suitable for further clinical trials of these forms.

Materials and methods

Materials and methods. The following materials were used in the work: sulfated arabinogalactan in the form of potassium salt, obtained at the A.E. Favorsky Irkutsk Institute of Chemistry Siberian Branch of the Russian Academy of Sciences; Ludipress®; AEROSIL® 200 Pharma; calcium stearate; Aquacoat ECD. The powder mixtures were briquetted followed by tableting and application of the finished film coating Aquacoat ECD, and encapsulation in hard gelatin capsules.

Results

Results. Composition and technological characteristics of capsules and film-coated tablets were determined using physico-chemical and technological properties of sulfated arabinogalactan in the form of potassium salt. Technological parameters and quality indicators were determined for the solid pharmaceutical dose forms in accordance with the requirements of the State Pharmacopoeia of the Russian Federation of the XIVth edition.

Conclusion

Conclusion. The optimum compositions and technology for the preparation of capsules and film-coated tablets based on potassium salt of sulfated arabinogalactan for the prevention and treatment of atherosclerotic lesion of blood vessels, were developed. The data obtained were used for the regulatory documentation design.

сульфатированный арабиногалактантаблеткипокрытые пленочной оболочкойкапсулытехнология производстваsulfated arabinogalactanfilm-coated tabletscapsulesproduction technologyРабота выполнена согласно планам НИР (государственное задание) по программе V.48 «Фундаментальные физико-химические исследования механизмов физиологических процессов и создание на их основе фармакологических веществ и лекарственных форм для лечения и профилактики социально значимых заболеваний» (2013–2020). Проект V.48.1.2. Поиск новых биологически активных веществ на основе биомассы хвойных пород Сибири и Дальнего Востока, скрининг биологической активности перспективных соединений. 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The authors declare that there are no conflicts of interest present.