ИССЛЕДОВАНИЕ ОСТРОЙ ТОКСИЧНОСТИ КОМБИНИРОВАННОЙ ТАБЛЕТИРОВАННОЙ ЛЕКАРСТВЕННОЙ ФОРМЫ ЦИТИКОЛИНА И МЕМАНТИНА

Abstract

The development and study of the fixed dose combination tablets of citicoline and memantine is the relevant problem. The purpose of this study was the assessment of acute toxicity and local irritating effect of the new combined drug, the modified release tablets (citicoline 500 mg + memantine 10 mg). Material of research: fixed dose combination of modified release tablets (citicoline 500 mg + memantine 10 mg) (NovaMedica Innotech, Russia). The tested drug was administered intragastrically to males and females of half-plant outbred rats at a dose of 2000 mg/kg in the amount of active substances. According the research results, the death of animals was not noted. As it was found the value of LD50 for the test drug in the intragastric administration is>5000 mg/kg in accordance with OECD Test No.423. The tested drug can be attributed to the 5th grade of toxicity on the international classification of GHS, because LD50> 5000 mg/kg (V/g) and to 4 class of low-toxic compounds as per Hodge and Sterner classification: 500 <d50 ≤ 5000 mg/kg (V/g). No clinical signs of intoxication in males and females of autumn rats against the background of a single intragastric administration of the test drug was detected visually, There were no changes in animals behavior in the direction of oppression or excitement. The test drug in a single intragastric introduction in a dose of 2000 mg/kg in the amount of active ingredients did not cause a local irritant action. Thus, the drug does not have a toxic and local irritating action in one-time introduction.