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Vol. 21, Art. 11 (pp. 119-126)    |    2020       

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Safety study of a new nootropic drug based on a fumaric acid derivative

1 Saint- Petersburg state chemical and pharmaceutical University of the Ministry of health of Russia, 197376, St. Petersburg
2 Institute of Toxicology of Federal Medico-Biological Agency, 192019, St. Petersburg

Brief summary

Studies have been conducted to assess the safety of the derivative of the fumaric ethanolamine ester (EFD) with a single administration of its various doses to rodents. The average lethal doses (LD50) of the tested pharmaceutical substance in mice were 2070 220 mg / kg (males) and 1990 - 250 mg / kg (females) when administered intravenously, and 2550 - 430 mg / kg (males) and 2550 240 mg / kg (females) after subcutaneous administration. With a single oral administration of EFD at doses of 300 mg / kg and 2000 mg / kg, the death of mice and rats of both sexes was not observed. In addition, EFD with a single intragastric administration in doses exceeding the therapeutic does not cause irritation of the mucous membrane of the stomach and duodenum. EFD, a substance with pronounced nootropic activity, is a safe substance.


Key words

average lethal dose, ethanolamine fumarate derivative, mice, rats, safety, succinic salt.

Reference list

Titovich I. A., Bolotova V. C. Eksperimentalnoe izychenie antigipoksicheskoi aktivnosti novogo proizvodnogo aminoetanola // Biomedicina. - 2016. - N. 1. - S. 77 - 83.


2. Bolotova, V.C. Titovich I.A., Shystov E.B. Izychenie neĭroprotektornoĭ aktivnosti proizvodnogo fymarovoĭ kisloti y ishemizirovannih kris. // Mat. mejd. konf., posvyashennoi 60-letiu farmacevticheskogo fakylteta «Vitebskii GODNMY» «Sovremennie dostijeniya farmacevticheskoi nayki i praktiki», Vitebsk, Respyblika Belarys, 31 oktyabrya 2019 goda. - C. 235-236.


3. GOST R 56700-2015 Lekarstvennie sredstva dlya medicinskogo primeneniya. Doklinicheskie farmakologicheskie issledovaniya bezopasnosti. Ytverjden prikazom ot 11 noyabrya 2015 goda 1761 - st. 2015. - 18 s.


4. Rykovodstvo po doklinicheskim issledovaniyam bezopasnosti v celyah provedeniya klinicheskih issledovanii i registracii lekarstvennih preparatov. Evraziiskaya ekonomicheskaya kollegiya. 2019 (2020). - 36 s.


5. Prozorovskii V.B., Prozorovskaya M.P., Demchenko V.M. Ekspress-metod opredeleniya srednei effektivnoi dozi i ee oshibki // Farmakol. i toksikol. - 1978. - N4. - S. 497-502.


6. Organization for Economic Co-operation and Development OECD guideline for testing of chemicals. Guideline 423: Acute oral toxicity - Acute toxic class method, Paris: Organization for Economic Co-operation and Development. 2001. 14 p.


7. Rykovodstvo po provedeniu doklinicheskih issledovanii lekarstvennih sredstv. Chast pervaya / Pod red. A.N. Mironova. - M.: Grif i K. 2012. 944 s.


8. Karen, E., Haneke M.S. Dimethylethanolamine (DMAE)[108-01-0] and Selected Salts and Esters: Review of Toxicological Literature (Update). Report on National Institute of Environmental Health Sciences Contract. N01-ES-65402, 2002 [Electronic resource]. National Toxicology Program, 2018 Access mode: https://ntp.niehs.nih.gov/ntp/htdocs/chem_back-ground/exsumpdf/ dmct_508.pdf (circulation date: 15.06.2017).