Study of compatibility of components of a new combined drug for treatment of alcoholic intoxication and its hepatoprotective effect on a model of alcoholic liver injury




alcoholic hepatitis, effervescent powder, compatibility, physical and chemical properties, hepatoprotective effect


The aim of the work is the development of a combined drug for use in alcohol intoxication based on the physicochemical properties and chemical compatibility of active pharmaceutical ingredients and excipients, and the study of the hepatoprotective effect in alcoholic hepatitis in rats.

Materials and methods. During the studies, physical and physicochemical methods were used, a Specord 200 spectrophotometer (Germany), analytical scales Sartorius (SARTORIUS, Germany), class A volumetric glassware and reagents that meet the requirements of the State Pharmacopoeia of Ukraine (SPhU). Alcoholic hepatitis in rats was reproduced by intragastric administration of an aqueous 40% ethanol solution at a dose of 7 ml/kg for 1 week.

Results. A new combined agent is proposed for use in alcohol intoxication in the form of an effervescent powder for the preparation of an oral solution, which contains glycine, L-glutamic acid, acetylsalicylic acid, ascorbic acid, fructose / sorbitol and sodium bicarbonate and citric acid to accelerate the dissolution of medicinal substances. To study the compatibility of the components, experimental studies of hygroscopicity, chemical interaction / chemical stability and an assessment of the redox potential of the proposed active pharmaceutical ingredients were carried out. To study the stability of the API, studies were carried out on sugaramine condensation due to the choice of amino acids and ascorbic acid in the composition of drugs. Based on the research results, it was decided to divide the API into 2 packages, separating sodium bicarbonate and glycine, which can interact with ascorbic acid / acetylsalicylic acid and ascorbic acid, respectively. In an in vivo experiment, it was found that the use of the new drug is accompanied by the normalization of the antioxidant-prooxidant status of the liver due to a likely decrease in the TBA-AP level and an increase in the RG index in the liver homogenate relative to the control group.

Conclusions. Evaluation of the physicochemical properties of API allowed us to propose a new combined drug (TS-PP) for use in alcohol intoxication in the form of an effervescent powder for the preparation of oral solution. In alcoholic hepatitis in rats, it was found that the use of the studied drug largely prevents the formation of the effects of the toxic effects of ethanol on the rat organism, which is manifested by inhibition of destruction of hepatocyte membranes, a decrease in the level of LPO products, restoration of the RG index and improvement of the protein synthesizing function of the liver due to the complex effect of amino acids and ascorbic acid contained in the product

Author Biographies

Olha Rudakova, National University of Pharmacy

Postgraduate Student,

Department of Pharmaceutical Chemistry


Cyclic Committee of Pharmaceutical Chemistry and Pharmacognosis

Svitlana Gubar, National University of Pharmacy

PhD, Associate Professor,

Department of Pharmaceutical Chemistry

Nataliia Smielova, National University of Pharmacy

PhD, Assistant

Department of Pharmaceutical Chemistry

Dmytro Lytkin, National University of Pharmacy

PhD, Vice-director

Educational and Scientific Institute of Applied Pharmacy

Tatiana Briukhanova, National University of Pharmacy

PhD, Assistant

Department of Biochemistry

Elena Bezchasnyuk, National University of Pharmacy

PhD, Head of Laboratory

State Research Laboratory for Quality Control of Medicines

Nataliia Bevz, National University of Pharmacy

PhD, Associate Professor

Department of Pharmaceutical Chemistry

Victoriya Georgiyants , National University of Pharmacy

Doctor of Pharmaceutical Sciences, Professor, Head of Department

Department of Pharmaceutical Chemistry


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How to Cite

Rudakova, O., Gubar, S., Smielova, N., Lytkin, D., Briukhanova, T., Bezchasnyuk, E., Bevz, N., & Georgiyants , V. (2021). Study of compatibility of components of a new combined drug for treatment of alcoholic intoxication and its hepatoprotective effect on a model of alcoholic liver injury. ScienceRise: Pharmaceutical Science, (6 (34), 91–100.



Pharmaceutical Science