Synthetic genistein is a potential active pharmaceutical substance for the development of radiation countermeasure agents

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Abstract

The development of dosage forms of effective radiation countermeasure agents remains an urgent task of modern radiobiology. The purpose of this study is to determine the quality indicators of domestic synthetic genistein as a potential active pharmaceutical substance for the development of radiation countermeasure agents. The material of the study was two samples of genistein synthesized at the SPC “Farmzashchita” of the FMBA of Russia and at the St. Petersburg State Chemical and Pharmaceutical University of the Ministry of Health of Russia, and natural genistein isolated from soybean seed cake (Glycine max L. Merr.). The quality of synthetic and natural genistein was evaluated using infrared Fourier spectroscopy, nuclear magnetic resonance H1 and C13 spectroscopy, and Raman spectroscopy. It was established that according to the studied spectra, the genistein samples do not differ from each other, the structure of the molecule is confirmed, there are no additional signals in them. The method of non-aqueous titration of genistein with potentiometric determination of the end point of titration in dimethylformamide medium, which is recommended to be included in the regulatory documentation for genistein drug substance, has been developed and validated. The method of high-performance liquid chromatography of quantitative determination of genistein for further study of biologically active additives and medicinal products based on it has been developed and tested.

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About the authors

Viktoria V. Tikhonova

St. Petersburg State Chemical and Pharmaceutical University of the Ministry of Health of the Russian Federation

Email: viktoriya.tichonova@pharminnotech.com
ORCID iD: 0000-0002-1184-6453
Russian Federation, St. Petersburg

Tatyana V. Sotnikova

St. Petersburg State Chemical and Pharmaceutical University of the Ministry of Health of the Russian Federation

Email: tatyana.sotnikova@spcpu.ru
ORCID iD: 0009-0004-8991-7866
Russian Federation, St. Petersburg

Gleb V. Erlin

St. Petersburg State Chemical and Pharmaceutical University of the Ministry of Health of the Russian Federation

Email: gleb.erlin@spcpu.ru
ORCID iD: 0009-0006-2202-7919
Russian Federation, St. Petersburg

Olga Yu. Strelova

St. Petersburg State Chemical and Pharmaceutical University of the Ministry of Health of the Russian Federation

Author for correspondence.
Email: olga.strelova@pharminnotech.com
ORCID iD: 0000-0001-6737-1023
Russian Federation, St. Petersburg

Alexander N. Grebenyuk

St. Petersburg State Chemical and Pharmaceutical University of the Ministry of Health of the Russian Federation

Email: grebenyuk_an@mail.ru
ORCID iD: 0000-0002-9381-194X
Russian Federation, St. Petersburg

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Supplementary files

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2. Fig. 1. IR-spectrum of genistein.

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3. Fig. 2. Nuclear magnetic resonance spectrum of genistein (А – Н1, В – С13).

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4. Fig. 3. Chromatogram of genistein (HPLC, 0.0805 mg/ml solution).

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