Preclinical searches of the preparation Thireomagnile

Gutyj, B. V.; Grymak, Y.; Hunchak, V.; Mysak, A. R.; Nazaruk, N. V.; Brezvyn, O. M.; Hariv, I.; Shcherbatyy, A. R.; Семенів, Богдан; Бушуєва, Інна Володимирівна; Парченко, В. В.; Kaplaushenko, A. G.

doi:10.15421/2018_267

Cited by 16 publications

(15 citation statements)

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“…Одним із перших етапів фармакологічного дослідження ветеринарних препаратів є встановлення токсичності (SOU 85.2-37-736:2011;Gutyj et al, 2018;Todoriuk et al, 2018), тому метою нашої роботи було вивчення гострої та підгострої токсичності препарату на основі тилозину тартрату.…”

Section: вступunclassified

Acute and subacute toxicity of the drug based on tylosin tartrate

et al. 2019

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The article presents the results of a study of the acute and subacute toxicity of the drug TILOTAR (a water-soluble powder for oral administration) made on the basis of tylosin tartrate. As a result of the research it was found that the drug "TILOTAR" refers to the 4th class of toxicity, that is, to low-toxic substances. After intragastric administration of the drug to white mice and rats at doses of 2500, 5000, 7500 mg/kg, all animals remained alive. Short-term inhibition was recorded in laboratory animals, which were given the drug at the maximum dose. Further changes in the clinical state of the animals of the experimental groups were not observed. The study of subacute toxicity of the drug "TILOTAR" showed that 14-day administration of a therapeutic dose of the drug leads to a decrease in erythropoiesis, the appearance of old forms of erythrocytes, damage to hepatocytes, the appearance of eosinophils, γglobulins, a decrease in protein biosynthesis, increased kidney function. The introduction of a 10-fold dose within 14 days reduced the body weight of the rats, leading to abnormalities in the liver and kidneys, and a decrease in the mass of the spleen. An increase in urea blood concentration and a decrease in creatinine may indicate impaired renal function in animals that were given a tenfold dose of the drug, and an increase in the level of α-and γ-globulins against the background of a decrease in body weight of rats indicates an overload of the body's immune system. In rats of the therapeutic group, homeostasis was maintained by enhancing kidney function, accompanied by a decrease in the number of erythrocytes due to young forms and the appearance of mature erythrocytes with a high level of hemoglobin (MCH), some destruction of hepatocytes (high level of alkaline phosphatase activity) while reducing the amount of albumin, an increase in relative levels of α-and γ-globulins. In the conducted experiments it was established that the macroscopic and microscopic structure of the internal organs of rats, while studying the subacute toxicity of the drug "TILOTAR", was preserved, no macroscopic changes were revealed. In rats receiving a 10-fold therapeutic dose of the drug for 14 days, focal protein dystrophy of the liver and kidneys was histologically established. 1 Державний науково-дослідний контрольний інститут ветеринарних препаратів та кормових добавок, м. Львів, Україна 2 ПрАТ "Технолог", м. Умань, Черкаська обл., Україна У статті наведені результати вивчення гострої та підгострої токсичності препарату "ТИЛОТАР" (водорозчинний порошок для перорального застосування), виготовленого на основі тилозину тартрату. У результаті проведених досліджень було встановлено, що препарат "ТИЛОТАР" належить до 4-го класу токсичності, тобто до малотоксичних речовин. Після внутрішньошлункового введення препарату білим мишам і щурам в дозах 2500, 5000, 7500 мг/кг всі тварини залишалися живими. Короткочасне пригні-

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Section: вступunclassified

Acute and subacute toxicity of the drug based on tylosin tartrate

et al. 2019

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“…Для профілактики і лікування післяродових внутрішньоматкових інфекцій у корів, кобил, свиноматок, овець і кіз ПП "Біофарм" спільно з Дослідною станцією епізоотології ІВМ НААН розроблено новий аерозольний внутрішньоматковий препарат "Йодозол", до складу якого входить йод та калію йодид (Sachuk & Katsaraba, 2018). Обов'язковою умовою реєстрації нових лікарських препаратів є їхні клінічні дослідження, у тому числі щодо ефективності та толерантності (Kosenko et al, 1997;Muzyka, 2014;Todoriuk et al, 2018;Gutyj et al, 2018). Відповідно до законодавства розвинених країн світу, правил Належної виробничої практики одним з обов'язків розробника є випробування, які необхідно здійснювати і на етапі розроблення активної речовини і лікарського препарату.…”

Section: вступunclassified

The research of tolerance of solution for intrauterus application “Yodozol”

Сачук¹,

Кацараба

Stravsky

et al. 2019

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Complex clinical trials have been carried out in order to study the tolerance and detail of the effect on the morpho-functional state of the organism of target animals of the new development of PE "Biopharm" and the Experimental Station of Epizootology IVM NAAS -solution for intrauterus use in the form of aerosol "Yodozol", which will help predict the appearance of side effects from drug and prevent it. Methods of evaluation of a medicinal product for clinical trials, including for determining tolerance limits, which were used, included: the determination of the general clinical state of the organism, the study of hematological and biochemical parameters of blood, the control of the age of their first calving and service period, as well as statistical (calculation of average values and error of experimental data). "Yodozol" is a light yellow liquid, 1 ml of which contains 5 mg of iodine and 10 mg of potassium iodide. The drug is used for the prophylaxis and treatment of postpartum intrauterine infections in cows, pigs, sheep and goats (endometritis, pyrometers, cervicitis, vaginitis, delayed digestion caused by microorganisms sensitive to iodine), after giving rhombus, cesarean section and postpartum sanitation of the uterus. Medical product possesses antimicrobial, anti-inflammatory and analgesic actions, improves proliferative processes of genital organs, reduces the time of recovery of animals. The drug is used in accordance with the guidelines, after which livestock products are used without restriction. It has been established that the new medicinal product "Yodozol" with three times intrauterine application of cattle at intervals of 48 hours in doses that 2-10 times exceeds the recommended therapeutic, is tolerant. The excess amount of the drug does not cause significant side effects when injected into the uterus. There was no negative influence on the general clinical condition of cows and changes in the morpho-functional state of their organism. Three animals had an increase in the volume of the uterus, omission of horns and the body of the uterus. However, this is a normal individual physiological local reaction of the body to the introduction of an increased amount of foreign matter, which does not affect the general physiological state of animals. The volume and physiological placement of the uterus independently came to normal after the discontinuation of the drug. In all experimental animals exposed to different doses of the iodosol drug, the age of their first calving was from 29.0 ± 1.87 to 33.7 ± 2.27 months, the service period from 76.3 ± 2.27 to 81.0 ± 0.71 days, fluctuating within the limits of physiological norms. All conducted studies of the tolerance of the solution for intrauterine application "Yodozol" were included in the registration materials of the medicinal product.

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“…У першу добу досліду тварини знаходились під постійним наглядом. За цих умов враховували такі показники: загальний стан, зовнішній вигляд, особливості поведінки тварин, інтенсивність та характер рухливої активності, наявність судом, координацію рухів, реакцію на зовнішні подразники (тактильні, звукові, світлові), стан волосяного покриву, видимих слизових оболонок, відношення до корму, ритм, частоту дихання, час виникнення та характер інтоксикації, її важкість, перебіг, час загибелі тварин або їх одужання (Kotsiumbas et al, 2006;Gutyj et al, 2017;Todoriuk et al, 2018;Gutyj et al, 2018).…”

Section: матеріал і методи дослідженьunclassified

Determination of acute toxicity of “Bendamin” drug in laboratory animals

Varkholiak

Gutyj

2018

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The study of acute toxicity is a mandatory stage in the investigation of new drugs, which allows assessing the health of substances for health in the short-term and determining the class of toxicity and breadth of therapeutic action. Therefore, at the first stage of the study, the acute toxicity of Bendamin Cardiomatography was studied, in particular the determination of maximum tolerant, toxic and intermittent lethal doses for laboratory animals. The acute toxicity of Bendamin was determined in two stages: indicative and expanded experiments. In the indicative trial, the drug was administered intragastrically at doses of 50, 500 and 5000 mg/kg body weight. Three white mice and rats were used for each dose. In an expanded experiment, Bendamin was administered intragastrically at doses of 5000 and 10000 mg/kg body weight. In determining the acute toxicity of Bendamin, the DL50 value could not be determined, indicating a low toxicity of the test substance. Thus, the DL50 drug for intragastric administration to white mice is greater than 5000 mg/kg m. The general condition of animals in the studied groups did not differ from the state of intact animals: coordination of movements and skeletal muscle tone, pain response, tactile and acoustic stimuli were adequate, the frequency of breathing and the rhythm of heart rate were within the normal range. At administration of the preparation in a dose of 5000 mg/kg m. T, an insignificant inhibition was established, which is related to the introduction of a large amount of the drug. In determining the coefficients of the mass of the internal organs of laboratory animals, a slight decrease in the weight coefficient of the liver was found in both mice and in rats. The "Bendamin" drug when administered to white mice and rats in the stomach in the maximum amount does not cause symptoms of poisoning and behavioral abnormalities. According to GOST 12.1.007-76, Bendamin, for intragastric administration, according to the degree of hazard belongs to grade 4 toxicity -low toxicity substances (DL50 more than 10000 mg/kg body weight). In the future, it is planned to investigate the chronic toxicity and cumulative properties of the drug in laboratory animals.

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Preclinical searches of the preparation Thireomagnile

Cited by 16 publications

References 0 publications

Acute and subacute toxicity of the drug based on tylosin tartrate

Acute and subacute toxicity of the drug based on tylosin tartrate

The research of tolerance of solution for intrauterus application “Yodozol”

Determination of acute toxicity of “Bendamin” drug in laboratory animals

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