The study of acute toxicity of drugs on the basis of the plant raw material for non-hormonal therapy of the climacteric syndrome




climacteric syndrome, acute toxicity, plant raw materials, drops, collection


Nowadays in Ukraine prevention and treatment of the climacteric syndrome is an urgent task of modern medicine since according to the WHO data approximately 45 % of women aged 50 years and older apply to hospitals with systemic manifestations of climacteric syndrome, namely hot flushes, the psychoemotional state disorders, depression, etc. Mostly, to reduce the effects of climax in women doctors use the substitution hormonal pharmacotherapy, which has a large number of side-effects, such as obesity, diabetes mellitus, and cardiovascular diseases. Therefore, it is necessary to expand the range of the pharmaceutical market of non-hormonal drugs based on the medicinal plant raw material, which exhibit the significantly less spectrum of side effects.

Aim. To study the acute toxicity of alcoholic drops and the herbal tea with the combined composition based on the medicinal plant raw material for non-hormonal therapy of the climacteric syndrome, assess the hazard of substances for health in the short-term effects and determine the class of toxicity.

Materials and methods. The study was conducted on 60 white outbred rats, males and females, with the body weight of 200-220 g. Before the study the animals were divided into groups of 6 animals in each. Twenty four hours prior the introduction of drugs all animals were deprived of food. The drugs were introduced in the morning under fasting condition. After oral administration of the test samples of the drugs animals were kept for additional 4 hours without food with free access to water. The test samples studied intragastrically were administered using a special enteral probe,
while intraperitoneal injection was performed using disposable three-piece syringes.

Results. Following the introduction of test samples in rats in the maximum dose of 5000 mg/kg enterally and 1000 mg/kg, parenterally the signs of intoxication in animals were not observed: all integral indices did not differ from those of intact animals. The animals were clean, active, had a satisfactory appetite, responded to sound and light stimuli, urination and defecation processes were normal, breathing disorders and convulsions were not observed. The reflex excitability in all animals was preserved. When monitoring animals for two weeks no deaths were observed in any of the experimental groups.

Conclusions. The complex of the research conducted in studying acute toxicity of alcoholic drops and the herbal tea with the combined composition based on the medicinal plant raw material in rats allowed to determine the absence of toxic effects of drugs in parenteral (LD50 > 1000 mg/kg) and enteral (LD50 > 5000 mg/kg) route of administration. According to the classification of substances by toxicity drops and the herbal tea refers to the IV toxicity class in intragastric and intraperitoneal administration.

Author Biographies

І. S. Konovalenko, National University of Pharmacy

Associate professor of Drug Technology Department, National University of Pharmacy

N. P. Polovko, National University of Pharmacy

Doctor of Pharmaceutical Science, professor, head of the Drug Technology Department

D. V. Litkyn, National University of Pharmacy

PhD student of Biological Chemistry Department

A. L. Zagayko, National University of Pharmacy

Doctor of Biology (Dr. habil.), professor of the Biological Chemistry Department, vice-rector for Academic Affairs and Research


Krasilshchikova, M. S., Belozertceva, I. V., Kliubin, I. V. (2012). Laboratory Animals Ltd. (LAL). Sankt–Petersburg, 45–48.

Witchl, M. (2012). Herbal Drugs and Phytopharmaceuticals: a handbook for practice on a scientific basis. London: Stuttgart, 688.

Berezovskaia, I. V. (2003). Khimiko–farmatcevticheskii zhurnal, 3 (37), 32–34.

Sidorov, K. K. (1973). Toksikologiia novykh promyshlennykh khimicheskikh veshchestv. Moscow: Meditcina, 3, 47.

Konovalenko, I. S., Polovko, N. P. (2017). Vestnik Habarshysy Yuzhno–Kazakhstanskoi gosudarstvennoi akademii, 3 (80), 57–60.

Kovalenko, V. M., Stefanov, O. V. et al. (2001). Doklinichni doslidzhennia likarskykh zasobiv. Kyiv, 74–97.

Salimov, R. M. (2000). Rukovodstvo po eksperimentalnomu (doklinicheskomu) izucheniiu novykh farmakologicheskikh veshchestv.

Moscow: Remedium, 349–354.

Murashko, N. K. (2013). Medychna hazeta «Zdorovia Ukrainy», 15–16 (316–317), 42–43.






Pre-clinical studies of new drugs