Screening studies of Сombiderm tablets
DOI:
https://doi.org/10.11603/mcch.2410-681X.2018.v0.i2.9075Keywords:
Combiderm tablets, acute toxicity, hypoglycemic effect, the most effective dose, comparison with the referent product.Abstract
Introduction. Diabetes mellitus is one of the global medical, social and economic problems of the present, the treatment of which requires an integrated approach to prevent the development of metabolic, structural and functional disorders in the body. Potential source of hypoglycemic agents can be products of natural origin. The object of the research was new promising natural remedy under the conventional name "Combiderm" in the form of tablets.
The aim of the study – to establish the safety of the application of the developed tablets “Combiderm” and to study the features of hypoglycemic activity.
Research Methods. Acute toxicity was studied at the intragastric route of administration to white rats of two sexes. The specific pharmacological activity of the Combiderm tablets was determined by the hypoglycemic effect on the models in rats. For the eccentricity of the most euphemistic hypoglycemic activity of a dose of Combiderm tablets, the dynamics of glycemia was evaluated during the occlusal process of glucose prolongation. When establishing hypoglycemic activity, blood glucose levels were compared after administration of the test substance in the optimal therapeutic dose of 100 mg/kg and Arfa combi referent product
Results and Discussion. The total weight of males was 13.6 % (p<0.05), and 8.6 % (p<0.05). The total number of males was 13.6 % (p<0.05), and the rate of infection was 14.6 % (p<0.05). In the near future, Combiderm tablets reduce the amount of glucose in the blood of animals, which was malaise-like. The hypoglycemic effect of the test substance was most pronounced in the first 30 minutes after glucose loading. In the dose of 50 mg/kg, the level of glycemia decreased in comparison with the similar indicator of animals that did not receive the study drug – by 23.6 %, at a dose of 75 mg/kg – by 41.2 %, at a dose of 100 mg/kg – by 68.6 %, at a dose of 125 mg/kg – by 66.7 % and at a dose of 150 mg/kg – by 72.6 % (p<0.05). Comparing the hypoglycemic curves of the Combiderm and the reference product of the Arfa сombi, there was a tendency towards a decrease in glucose in both groups with the best hypoglycemic effect in the group of animals administered the test substance.
Conclusions. The developed Combiderm tablets refer to the V class of toxicity (practically non-toxic substances) according to the classification of K. K. Sydorov, since their DL50>5000 mg/kg with intravenous gastric
administration. The results of the studies showed that the most effective among the tested doses of the test substance is 100 mg/kg, with prophylactic administration, an intensive and prolonged decrease in glucose concentration in the blood of the experimental animals at the all points of the experimental time was observed. The analysis of the results of studies of hypoglycemic activity of the test drug showed that Combiderm tablets at a dose of 100 mg/kg in the oral glucose tolerance test showed a more distinct hypoglycemic effect, which significantly prevailed hypoglycemic effects of Arfa combi referent drug in a dose of 150 mg/kg during the entire duration of the experiment.
References
Olmo-Garcia, M.I., & Merino-Torres, J.F. (2018). GLP-1 Receptor agonists and cardiovascular disease in patients with type 2 diabetes. Journal of Diabetes Research, 2018, 1-12.
Trygubchak OV (2015). Analysis of the assortment of antidiabetic drugs at the pharmaceutical market of Ukraine. News of Pharmacy, 3 (83), 51-55.
Ezhned, M.A., Horoshko, O.M., Drachuk, V.M., & Hroshovyi, T. A. (2014). Doslidzhennia hipohlikemichnoi dii ekstraktu z koreniv ta korenevyshch omanu vysokoho [Investigation of hypoglycemic action of extract from roots and rhizomes of deceit high]. Farmatsevtychnyi chasopys – Pharmaceutical Journal, (3), 85-88 [in Ukrainian
Tryhubchak, O.V. (2016). Tekhniko-ekonomichne i farmakoterapevtychne obhruntuvannia vyrobnytstva tabletok na osnovi krioliofilizovanoi ksenodermy svyni [Techno-economic and pharmaco-therapeutic substantiation
of production of pills based on cryolophilized xenoderm pigs]. Materialy III naukovo-praktychnoi internetkonferentsii z mizhnarodnoiu uchastiu. Tovaroznavchyi analiz tovariv obmezhenoho aptechnoho asortymentu –
Materials of the III Scientific and Practical InternetConference with International Participation. Commodity analysis of goods of a limited pharmacy assortment.
Kharkiv. (pp. 149-150) [in Ukrainian].
Huda, N.V., & Tsymbaliuk, A.V. (2012). Vmist aminokyslot ta mikroelementiv u krioliofilizovanyi ksenoshkiry yak pokaznyk yii biolohichnoi aktyvnosti [The content of amino acids and trace elements in cryolophilized
xenose as an indicator of its biological activity]. Medychna ta klinichna khimiya – Medical and Clinical Chemistry, 14 (1), 70-72 [in Ukrainian].
Stefanov, O.V. (2001). Doklinichni doslidzhennia likarskykh zasobiv: metodychni rekomendatsii [Preclinical research of medicinal products: methodical recommendations]. Kyiv: Avitsenna [in Ukrainian].
Krieger, J.P., Santos da Conceição, E.P., SanchezWatts, G., Arnold, M., Pettersen, K.G., Mohammed, M., … Modica, S. (2018). Glucagon-like peptide-1 regulates brown adipose tissue thermogenesis via the gut-brain axis in rats. Am. J. Physiol. Regul. Integr. Comp. Physiol. doi: 10.1152/ajpregu.00068.2018.
Aleksandrov, A.A. (2014). Vozmozhnosti primeneniya fitopreparata Arfa® Kombi v lechenii sakharnogo diabeta i narusheniya tolerantnosti k glyukoze [Possibilities of application of phytopreparation Arfa® Combi in the treatment of diabetes mellitus and violation of glucose tolerance]. Endokrinologiya – Endocrinology, 19 (1), 38-43 [in Russian].
Rybolovlev, Yu.R., & Rybolovlev, R.S. (1979). Dozirovaniye veshchestv dlya mlekopitayushchikh po konstantam biologicheskoy aktivnosti [Dosage of substances for mammals according to biological activity constants]. Doklady AN SSSR – Reports of the USSR Academy of Sciences, 247 (6), 1513-1516 [in Russian].