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The concept of Quality-by-design (QbD) in modern phytopreparation development: Influence of ecological factors on the chemical composition of plants of the genus Iris and their pharmacological activity.


Presented National Pharmaceutical University


The scientific work is devoted to a comprehensive pharmacognostic in-depth study of raw materials of Iris hungarica and almost 30 different species and varieties of Irises of flora of Ukraine and neighboring European countries with a focus on the concept of Quality-by-Design for the probability of obtaining quality plant raw materials for the Ukrainian pharmaceutical industry. The paper presents experiments on the isolation of individual substances from Iris hungarica rhizomes, obtaining and research of herbal medicine based on raw materials of Iris hungarica, the development of Method of quality control on medicinal plant raw materials of Iris hungarica. It is the study of the influence of environmental factors (soil type and composition, air temperature, precipitation, geographical location, etc.) has a decisive influence on the biosynthesis of biologically active substances in Iris spp. and, accordingly, on the quality of raw materials. The obtained data will further contribute to the development of proper cultivation of medicinal plant raw materials to obtain traceable raw materials for both the food and pharmaceutical, medical or cosmetic industries. The developed method of obtaining mangiferin from the leaves of Iris hungarica can be introduced into industrial production with the subsequent production of a new antiherpetic drug of domestic market. No analogues have been found on the Ukrainian market so far. The production of plant raw materials of cultivated plants lags far behind in its development from the needs of the pharmaceutical industry, health care and other socially oriented sectors of the economy. Obtaining cultivated medicinal plant raw materials in comparison with wild raw materials, has a number of advantages: achieving high yields and quality of raw materials, the ability to consistently protect plants from diseases and pests, the possibility of using mechanization at different stages of cultivation, intensification of harvesting in a short time vegetation of the plant, the organization of rapid drying of large quantities of raw materials. When growing medicinal plants, ecologically clean raw materials are obtained. Among the existing implemented projects are quality control methods "Folia Iris hungarica", "Rhizomata Iris hungarica", "Iridis hungaricae folii extractum siccum", "Iridis hungaricae rhizomata extractum siccum", which can be used in industrial production were development. For the first time, a new method of isolating mangiferin from the leaves of Iris hungarica was developed (applications for inventions in 2019 10508 and utility model patent № 42932). The results of research on the optimal conditions for cultivation and harvesting of Irises in accordance with good agricultural practice are presented in 2 information letters. The materials of the work are introduced into the educational process of related pharmaceutical departments of the country. Thus, the already conducted research will contribute to the development of stages of proper controlled cultivation and production of quality domestic raw materials of Iridaceae plants

Number of publications: including articles: articles – 57 (23 from Scopus/WoS); monographs – 1, newsletters – 5, copyright certificate – 1. The total number of references to the authors' publications/h-index of the work, according to the databases is: Web of Science - 30/3, Scopus - 60/5, Google Shcolar - 169/8. Received 7 patents of Ukraine.