Determination of quality indicators of a combined nootropic drug

Abstract

Introduction. The state drug policy of the Republic of Uzbekistan is aimed at the release of new affordable import-substituting drugs of domestic production, which are not inferior in activity to foreign analogues. Taking this into account, and also taking into account the high cost of imported nootropic drugs, the pharmaceutical production of LLC «Тemur med farm», Syrdarya region, Uzbekistan has developed the composition, technology and production of the combined drug "Nootrotem". "Nootrotem" is a combined preparation of piracetam and methylethylhydroxypyridine succinate in an injectable dosage form. Based on preclinical pharmacological studies, the pronounced nootropic and metabolic effects of the studied drug have been proven. Objective: The purpose of these studies is to develop quality assessment methods and establish quality indicators of the combined drug "Nootrotem" solution for infusions. Material and methods. 5 series of laboratory samples of the drug "Nootrotem" solution for infusions obtained at the pharmaceutical production "Temur med farm", Uzbekistan, were used as research objects. Results. The determination of the quality indicators of the studied drug was carried out in accordance with the modern requirements of the National pharmacopoeia of the Republic of Uzbekistan and the European pharmacopoeia, as well as in accordance with the general technical regulations on the safety of medicines. Conclusion. As a result of the conducted research, the main quality indicators of the drug "Nootrotem" solution for infusions were established according to the following indicators: description, authenticity, transparency, chromaticity, pH, package filling volume, mechanical inclusions, impurities, residual sulfur dioxide, osmolality. The limits of their rationing have been established in accordance with the State Budget of the Republic of Uzbekistan.