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Information × Registration Number 0224U032714, (0124U003612) , R & D reports Title Development of the innovative medicinal product "Koaguloks_N" with antimicrobial, hemostatic and wound-healing properties" popup.stage_title Відпрацювання умов отримання, підготовки та методів контролю вихідних компонентів розроблюваного лікарського засобу «Коагулокс_N» Head Zatovskyi Ihor V., д.х.н. Registration Date 02-12-2024 Organization F. D. Ovcharenko Institute of Biocolloidal Chemistry NAS of Ukraine popup.description1 The goal of the project is the development of a domestic inexpensive complex medicinal product "Koaguloks_N" with antimicrobial, hemostatic and wound-healing effects, which can be effectively used at all stages of wound treatment: during first aid, treatment and during rehabilitation. Optimization of the composition, methods of control and conducting the necessary therapeutic (antimicrobial) and toxicological testing of the agent as part of preclinical tests for the Registration Dossier of the dosage form is foreseen. popup.description2  The aim of the work stage was to optimize the conditions for obtaining and propose methods for quality control of intermediate products used for the manufacture of the medicinal product "Koaguloks_N" (metakaolin, extracts of unripe walnut fruits or leaves, silver and gold nanoparticles), as well as to characterize the obtained silver and gold sols using physicochemical methods, to determine their biocompatibility and the possibility of combining with aqueous-alcoholic extracts of unripe walnut fruits. The following methods were used in the research: differential thermal analysis, X-ray phase analysis, rheological research methods, gravimetry, atomic emission spectroscopy with inductively coupled plasma, scanning electron microscopy, UV/Vis spectroscopy, microbiological research, etc. Based on the results obtained, the temperature regimes (600-650 С) and time (30 min) of heat treatment of kaolin raw materials were optimized, and it was also recommended to use kaolin from the Glukhovets deposit in obtaining metakaolins for the composition “Koaguloks_N”. The structural, mechanical and rheological characteristics of Aerosil A-300 for water-alcohol solutions were considered and its compliance with the requirements as a thickener “Koaguloks_N” was shown. The methodology for extracting unripe walnut fruits and leaves with ethyl alcohol of various concentrations was worked out and it was shown that the equilibrium state of the extracts is usually ensured within 3-4 weeks, and the content of macro- and microelements in the extracts was also analyzed. It was shown that the obtained silver and gold nanoparticles, stable over time, are compatible with extracts of unripe nuts, and the conducted biological tests confirmed their biosafety. Based on the totality of the results obtained, propose a general technological scheme for obtaining the medicinal product "Koaguloks_N". Product Description popup.authors Zatovskyi Ihor V. Panko Andrii V. Prokopenko Vitalii A. Tsyhanovych Olena A. popup.nrat_date 2024-12-02 Close