ACUTE TOXICITY STUDY OF ARGOCIDE DRUG WHEN ADMINISTERED INTRAPERITONEALLY

Authors

  • Zh. M. Polova O. O. Bogomolets National Medical University
  • N. M. Seredinskaya Institute of Pharmacology and Toxicology NAMS of Ukraine

DOI:

https://doi.org/10.11603/2312-0967.2018.1.8694

Keywords:

preclinical research, veterinary drug, intraperitoneal administration, acute toxicity, Argocide.

Abstract

The aim of the work. Study of acute toxicity of the veterinary drug Argocide –solution for intracisternal administration with intraperitoneal administration to sexually mature white rats.

Materials and Methods. The object of the study was a series of a combined drug of Argocide containing silver citrate, D-panthenol and L-arginine for the treatment of subclinical mastitis in cattle. The acute toxicity study was carried out in experiments on white non-linear sexually mature rats of both sexes, according to the requirements for potential drugs. The tests were performed with intraperitoneal administration of the drug in various doses – from 2.0 to 6.3 ml / kg. Statistical processing of data was performed using the t-test of the Student. For the statistical processing of data, the MS Excel program was used.

Results and Discussion. As a result of the study of acute toxicity of Argoсide, it was established that integral indices of animal life– weight and body temperature did not undergo significant individual changes during 14 days of observation after single intraperitoneal administration. In studies of doses ranging from 1.58 ml / kg body weight of the animal to 5.0 ml / kg, it is determined that no case of death of domestic animals has been recorded with intraperitoneal administration of the drug at any dose. When using the drug in doses of 2.5 ml / kg and above, the animals showed clinical signs of intoxication immediately after the administration of the drug, which may be due to irritation of the peritoneum. Three days after the intraperitoneal administration of Argocide, no clinical signs of intoxication were observed.

Conclusions. The analysis of the obtained data allows to classify the Argocide drug, the solution for intracisternal injection according to the degree of safety to relatively harmless preparations (VI class), since the average lethal dose exceeds 3.0 ml / kg of body weight of the animal with intraperitoneal administration.

Author Biographies

Zh. M. Polova, O. O. Bogomolets National Medical University

PhD, association of professor , head of the department

department of pharmaceutical and industrial technology of medicines

O. O. Bogomolets National Medical University

N. M. Seredinskaya, Institute of Pharmacology and Toxicology NAMS of Ukraine

Doctor of Medicine Science
Institute of Pharmacology and Toxicology NAMS of Ukraine,
head of the laboratory of pharmacology of effector organs and systems

References

Methodological recommendations on the basic rules of good manufacturing practice and quality control of veterinary drugs. Available at: http://www.vet.gov.ua/node/1819. Ukrainian.

Kosenko YuM, Zaruma LYe, Kalynovska LV, Stefanyshyn HS, Shkilnyk, OS. [Manufacture of veterinary preparations according to the principles of Good Manufacturing Practice (GMP) - a strategy of quality assurance and compliance with international standards]. Scientific and technical bulletin of the Institute of Animal Biology and the State Scientific and Research Control Institute of Veterinary Preparations and Feed Additives. 2014;2-3: 340-5. Ukrainian.

On approval of the Procedure for conducting preclinical study of medicinal products and examination of materials for preclinical study of medicinal products. "Experimental study of the toxic effects of potential medicinal products"]. Nakaz MOZ Ukrainy № 944 vid 14.12.2009. Available at: http://zakon2.rada.gov.ua/laws/show/z0053-10. Ukrainian.

Polova Z., Almakayeva L., Nehoda T. Development of the composition of intramammary combined preparation based on silver citrate for veterinary. Сzech and slovak pharmacy. 2017;66(5): 227–33.

Polova ZhM, Sakhanda IV, Dolaychuk OP. [Study of toxicological properties of silver citrate as an active pharmaceutical ingredient]. Zbirnyk nauk prats spivrob. NMAPO im. P.L. Shupyka. 2016;24(4): 290-5. Ukrainian.

Council Directive 2010/63/EU of 22 September 2010 on the protection of animals used for scientific purposes. J of the Eur Com L 276.2010; 33-79.

The procedure for conducting scientific experiments, experiments on animals. Official Bulletin of Ukraine. - Official edition. The normative document of the Ministry of Education, Science, Youth and Sports of Ukraine. Order from 01.03.2012 № 249. 2012; 24: 82. Ukrainian.

Kotsyumbas IYa, Malyk OH, Patereha IP. Preclinical studies of veterinary medicinal products [Доклінічні дослідження ветеринарних лікарських засобів]. Lviv: Triad plus; 2006. Ukrainian.

O. V. Stefanov. Preclinical research of drugs: method. recommendations [Доклінічні дослідження лікарських засобів: метод. рекомендації] Kyiv: State pharmacolog center; 2001. Ukrainian.

Regulation on the Ethics Committee (bioethics) / (Normative document of the Ministry of Education, Science, Youth and Sports of Ukraine. Order from 11.11.2012 № 1287): Regulatory and legal framework of the Ministry of Education and Science of Ukraine (official website) [Electronic resource]. – k Available at: http://www.mon.gov.ua/ua/activity/63/64/normativno-pravova-baza/.

Experimental study of the toxic effects of potential medicinal products / Preclinical studies of medicinal products: [method. Recom.]. [Експериментальне вивчення токсичної дії потенційних лікарських засобів / Доклінічні дослідження лікарських засобів: [метод. рек.] Kyiv: Avicenna 2001. Ukrainian.

Prozorovskiy VB. [Statistical processing of the results of pharmacological studies]. Psikhofarmak. i boil. 2007;7(3-4): 2090-120. Russian.

Rebrova OYu. Statistical analysis of medical data. Application of the STATISTICA software package [Статистический анализ медицинских данных. Применение пакета прикладных программ STATISTICA]. Moscow: Media Sphere, 2006. Russian.

Trahtenberg IM, SHapovalova VA, Viktorov AP, SHapovalov VV, Kovalenko VN, Halin NM, Abrosimov AS. Principles and criteria for assigning medicinal products to the category of potent and poisonous [Принципы и критерии отнесения лекарственных средств к категории сильнодействующих и ядовитых]. State Pharmacological Center of the Ministry of Health of Ukraine. Kiev: 2002. Russian.

Published

2018-03-24

How to Cite

Polova, Z. M., & Seredinskaya, N. M. (2018). ACUTE TOXICITY STUDY OF ARGOCIDE DRUG WHEN ADMINISTERED INTRAPERITONEALLY. Pharmaceutical Review Farmacevtičnij časopis, (1), 123–129. https://doi.org/10.11603/2312-0967.2018.1.8694

Issue

Section

Pharmacological researches of biologically active substances