Pharmacy & PharmacologyPharmacy & PharmacologyФармация и фармакология2307-92662413-2241Eco-Vector11173510.19163/2307-9266-2022-10-2-154-163ArticlesСтатьиReview ArticleMinimisation of risks associated with the use of pollen-based medicines, at the stage of pollen collectionМинимизация рисков применения лекарственных препаратов на основе пыльцы на стадии заготовки сырьяhttps://orcid.org/0000-0001-5594-4859TaubeAleksandra A.ТаубэАлександра Альбертовна
Russian Federation

Candidate of Sciences (Pharmacy), Leading Researcher at the Center for Planning and Coordination of Research Works

кандидат фармацевтических наук, ведущий научный сотрудник Центра планирования и координации научно-исследовательских работ

Aleksandra.taube@pharminnotech.comhttps://orcid.org/0000-0001-7033-424XBuyanovaTatyana A.БуяноваТатьяна Анатольевна
Russian Federation

master’s student of the Department of Economics and Management

магистрант кафедры экономики и управления

buyanovatanya1@gmail.comSakanyanElena I.СаканянЕлена Ивановна
Russian Federation

Doctor of Sciences (Pharmacy), Director of Research

доктор фармацевтических наук, директор по науке

sakanjan@mail.ruScientific Centre for Expert Evaluation of Medicinal ProductsФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииSt. Petersburg Chemical and Pharmaceutical UniversityФедеральное государственное бюджетное образовательное учреждение высшего образования Санкт-Петербургский химико-фармацевтический университет» Министерства здравоохранения Российской ФедерацииJoint-Stock Company “Scientific and Production Association “Microgen”Акционерное общество «Научно-производственное объединение «Микроген»15042022102VOL 10, NO2 (2022)ТОМ 10, №2 (2022)15416306102022Copyright ©; 2022, Taube A.A., Buyanova T.A., Sakanyan E.I.Copyright ©; 2022, Таубэ А.А., Буянова Т.А., Саканян Е.И.Copyright ©; 2022,2022Taube A.A., Buyanova T.A., Sakanyan E.I.Таубэ А.А., Буянова Т.А., Саканян Е.И.https://creativecommons.org/licenses/by/4.0https://journals.eco-vector.com/2307-9266/article/view/111735

The aim of the study is the elaboration of Rules for Harvesting/Collecting of Pollen to minimize the risks associated with the use of pollen-based medicinal products.

Materials and methods. The following electronic resources were used in the study: PubMed, Medline, ScienceDirect, Web of Science, Scopus, Google Scholar, eLibrary, World Allergy Organization, Cochrane Database, Stallergenesgreer, Allergenscienceandconsulting, Pharmacopoeia, Fda.gov, fs.usda.gov, Ema.europa.eu. The analysis covered the period from January 1, 2010 until December 31, 2021.

Results. Currently, there are some general requirements for the quality of pollen in Russia, but there are no controls or standardised procedures for harvesting, drying, and purification of pollen. The USA and EU also lack established qualification programmes for pollen-collecting companies and/or individual pollen collectors. Regulatory authorities establish requirements only for visual control of raw materials or delegate responsibility to the manufacturer. The analysis of the existing regulatory documentation revealed lack of requirements for collection, storage, and processing of pollen used as the raw material for the production of allergen products. This calls for the elaboration of appropriate regulatory documents. The authors have compiled the Rules for Harvesting/Collection of Pollen, which include 6 parts. The Rules are intended for individuals directly involved in harvesting/collection of pollen, and contain requirements for pollen collectors, the process of pollen collection, documentation, storage, and transportation.

Conclusion. The authors have prepared the Rules for Harvesting/Collecting of Pollen, which include 6 parts. The Rules cover the whole process of pollen collection and all related processes. The implementation of this document will improve the process of pollen collection, thus reducing the risks associated with the use of pollen-based medicines. Further studies will assess the impact of the pollen quality on the safety of medicinal products.

Цель. Подготовка проекта Правил заготовки (сбора) растительной пыльцы для минимизации рисков при применении лекарственных препаратов на основе пыльцы.

Материалы и методы. В исследовании использовали следующие электронные ресурсы: PubMed, Medline, ScienceDirect, Web of Science, Scopus, Google Scholar, eLibrary, World Allergy Organization, Cochrane Database, Stallergenesgreer, Allergenscienceandconsulting, Pharmacopoeia, Fda.gov, fs.usda.gov, Ema.europa.eu. Поиск осуществляли за период с 1 января 201 по 31 декабря 2021.

Результаты. В настоящее время в России существуют общие требования к качеству пыльцевого материала, однако какой-либо контроль и стандартизация процесса заготовки, сушки и очистки отсутствует. В США и ЕС также отсутствуют установленные программы квалификации организаций по сбору пыльцы и/или индивидуальных сборщиков. Регуляторные органы ограничиваются визуальными требованиями к исходному сырью или возлагают ответственность на усмотрение производителя. В ходе анализа действующих нормативных документов было выявлено отсутствие требований в отношении сбора, хранения и обработки пыльцы, используемой в качестве сырья для производства лекарственных препаратов аллергенов. В связи с этим существует необходимость разработки нормативных документов. Составлены «Правила заготовки (сбора) пыльцы», в которых выделены 6 разделов. Правила предназначены для лиц, непосредственно осуществляющих заготовку (сбор) пыльцы, и содержат требования к заготовителям, к процессу сбора пыльцы, документации, хранению и транспортированию пыльцы.

Заключение. Составлены «Правила заготовки (сбора) пыльцы», в которых выделены 6 разделов. Составленные Правила полностью регламентируют процесс сбора пыльцы и все сопутствующие ему процессы. Внедрение документа позволит повысить качество сбора пыльцы, тем самым уменьшить риски применения лекарственных препаратов на ее основе. Планируется изучение влияния качества пыльцевого сырья на безопасность применения лекарственных препаратов.

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