RESEARCH OF ACUTE TOXICITY OF FIXED DOSE COMBINATION TABLETS OF CITICOLINE AND MEMANTINE

"Medical & pharmaceutical journal "Pulse" Pub Date : 2021-07-30 DOI:10.26787/nydha-2686-6838-2021-23-7-49-54

Salakhetdinov D.K., Sysuev B.B.

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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

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胞胆碱与美金刚固定剂量联用片的急性毒性研究

胞胆碱与美金刚固定剂量联合片的开发与研究是相关问题。本研究的目的是评价新的联合药物-胞胆碱改性缓释片(胞胆碱500 mg +美金刚10 mg)的急性毒性和局部刺激作用。研究材料:改良缓释片(胞胆碱500 mg +美金刚10 mg)固定剂量组合(NovaMedica Innotech，俄罗斯)。以活性物质量2000 mg/kg的剂量，给公、母半植物近交系大鼠灌胃。根据研究结果，没有注意到动物的死亡。根据OECD试验No.423的规定，试验药物灌胃的LD50值> 5000mg /kg。被试药物在国际GHS分类中属于第5级毒性，因为LD50> 5000mg /kg (V/g)，根据Hodge和Sterner分类，属于4级低毒化合物:500

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"Medical & pharmaceutical journal "Pulse"

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