Rudakova O. Development and standardization of a combined medicine for pharmacological correction of alcohol intoxication

The thesis offers theoretical and experimental substantiation of the composition, technology and quality control methods of the combined dosage form in the form of an effervescent powder for oral use with the purpose of alcohol intoxication treatment. The summarizes literature data on biochemical transformations that occur in the human body during alcohol poisoning, and pharmacotherapy to eliminate these unwanted effects. The analysis of the pharmaceutical market of medicines, used for reducing the symptoms of alcohol intoxication, proved that the effectiveness of most medicines depends on the content of active pharmaceutical ingredients (APIs), which most often affect individual components of the pathogenesis of the pathology. The characteristic of APIs and excipients chosen for dosage form production. The methods of pharmacotechnological, physico-chemical, pharmacological and microbiological studies, used during the development of the optimal composition and rational technology of powders for oral use, are given. For the development of quality control techniques, modern methods of analysis were chosen, including absorption spectrophotometry in the visible and ultraviolet regions (spectrophotometry), thin-layer chromatography (TLC), high-performance thin-layer chromatography (HPTLC), high-performance liquid chromatography (HPLC), semi-micro method of water estimation (K. Fisher method), etc. The conducted research made it possible to choose a rational composition of a combined medicines for the pharmacological correction of alcohol intoxication in the form of an effervescent powder for the preparation of an oral solution (with the distribution of the API mixture into two sachets, weighing 4000 mg each) under the conditional name "Aminoacetasc". As a result of carrying out pharmacological studies of the selected composition of the powder it was proved that the suggested medicine shows statistically significant activity on models of alcoholic hepatosis and single alcohol intoxication, which is not worse but even exceeds modern commercial products for pharmacocorrection of hangover syndrome. A project of quality control methods has been developed, containing a description of the methods of identification, testing and quantification of active pharmaceutical ingredients and pharmacotechnological tests. The technological scheme of the production of the medicinal product is proposed and the critical parameters of the technological process are determined. The developed and validated chromatographic methods of identification, quantitative determination of API, methods of determining the content of accompanying impurities for a combined medicinal product can be implemented in the practical activities of domestic pharmaceutical enterprises