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THE PRECLINICAL STUDY OF THE SAFETY CAPSULES, СОNTAINING GRAPE RED LEAVES DRY EXTRACT

DOI: https://doi.org/10.29296/25877313-2018-11-07
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Issue: 
11
Year: 
2018

L.V. Krepkova Ph.D. (Biol.), Head of Toxicology Department, All-Russian Scientific Research Institute of Medicinal and Aromatic Plants (Moscow) Е-mail: krepkowa2011@yandex.ru V.V. Bortnikova Ph.D. (Biol.), Leading Research Scientist, Department of Toxicology, All-Russian Scientific Research Institute of Medicinal and Aromatic Plants (Moscow) E-mail: bortnikova.v@yandex.ru O.S. Kuzina Senior Research Scientist, Toxicology Department, All-Russian Scientific Research Institute of Medicinal and Aromatic Plants (Moscow) Е-mail: oskt@list.ru M.V. Вorovkova Senior Research Scientist, Toxicology Department, All-Russian Scientific Research Institute of Medicinal and Aromatic Plants (Moscow) Е-mail:borovkova_65@mail.ru М.А. Dzhavakhyan Ph.D. (Рharm.), Head of Рharmaceutical Technology Department, All-Russian Scientific Research Institute of Medicinal and Aromatic Plants (Moscow)

Рurpose: preclinical toxicological study of capsules, containing grape red leaves dry extract. Methods: the study was carried out on male rabbits оf chinchilla breed with a body weight of 3.5-4.0 kg, which were received in the stomach 1capsule (dose of 50 mg/kg) or 3 capsules (dose of 150 mg/kg) for 90 days. Control animals were given placebo capsules. The integral, hematological and biochemical parameters, blood clotting time were determined, heart ratе, pathohistological studies were carried out. Results: the capsules were well tolerated by rabbits, did not cause a toxic effect and did not irritate the mucous membrane of the gastrointestinal tract. The long-term administration of the studied capsules in the stomach to rabbits at a dose of 50 mg/kg stimulated erythropoiesis, causing a relative increase in the number of red blood cells in the blood of animals, had a hypocholesterinemic effect, increased blood clotting time. The obtained results seem to be associated with the presence of flavonoids and resveratrol in the composition of the dry extract, in which the specified properties, including anti-inflammatory and antioxidant ones, are registered. Conclusions: the results of the Toxicological study allow us to recommend the study drug – capsules containing dry extract of red grape leaves 0,180 g, for clinical trials in the recommended therapeutic dose of 10 mg/kg.
Keywords: 
capsules
red leaf grape extract dry
chronic toxicity
rabbits

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