EVELOPMENT OF BETAINE HYDROCHLORIDE AS A PHARMACEUTICAL SUBSTANCE FOR THE PRODUCTION OF A DRUG ANALOG ACIDIN

DOI: https://doi.org/10.29296/25877313-2019-12-05
Issue: 
12
Year: 
2019

N.Sh. Kajsheva Dr.Sc. (Pharm.), Professor, Department of Pharmaceutical and Toxicological Chemistry, Pyatigorsk Medic-Pharmaceutical Institute - Branch FGBOU VO of the «Volgograd State Medical University» Ministries of Health of the Russian Federation (Pyatigorsk) E-mail: caisheva2010@yandex.ru A. Sh. Kajshev Ph.D. (Pharm.), Inter-Regional Rosalkogolregulirovaniya Office for North Caucasian Federal District (Essentuki) V.A. Mikelov Post-graduate Student, Pyatigorsk Medic-Pharmaceutical Institute - Branch FGBOU VO of the «Volgograd State Medical University» Ministries of Health of the Russian Federation (Pyatigorsk) A.V. Mnatsakanyan Lecturer, Pyatigorsk Medic-Pharmaceutical Institute - Branch FGBOU VO of the «Volgograd State Medical University» Ministries of Health of the Russian Federation (Pyatigorsk) E.A. Maslovskaya Senior Lecturer, Pyatigorsk Medic-Pharmaceutical Institute - Branch FGBOU VO of the «Volgograd State Medical University» Ministries of Health of the Russian Federation (Pyatigorsk) E-mail: ekatucha@yandex.ru

The aim of the study was to prove experimentally the possibility of separating betaine hydrochloride (acidin) from post-alcohol corn bard and to study its analytical parameters. The object of the bard corn grain distillery alcohol production enterprise «Suvorov». The technology of betaine hydro-chloride separation consists in: separation of bard into liquid and solid phases, removal of carbohydrates from the liquid phase (in the form of calcium saccharate), its neutralization with ammonium oxalate, concentration, treatment with concentrated hydrochloric acid, activated carbon, crystallization of betaine hydrochloride. The target product is purified with 96% alcohol, concentrated hydrochloric acid, recrystallization. To solve analytical problems, a substance used as a standard sample of acidin was isolated from the tablets «Acidin-pepsin» (Republic of Belarus). The test and standard samples of betaine hydrochloride were compared according to analytical parameters: physical and chemical (description, solubility in water and alcohol, pH of 1% aqueous solutions), authenticity (reaction of thermal decomposition of N-methylated α-aminoacids, complexation with copper (II) ions, deposition with silver ions), quantitative content (alkalimetric titration in the presence of phenolphthalein). As a result of the study, betaine hydrochloride (acidin) was isolated from the liquid phase of post - alcohol corn bard with a technological yield to the liquid phase - 0.8% (crude) and 0.4% (purified), which is 2-4 times more than molasses bard (traditional raw material). In addition to the target product (betaine hydrochloride), purified glutamic acid (0.1% to the liquid phase), calcium saccharate (3.0% to the liquid phase), a mixture of humins and potassium chlorides, sodium (0.4% to the liquid phase) are additionally isolated from the liquid phase of bards. According to physical and chemical parameters, the test and standard samples of betaine hydro-chloride are identical: white crystalline powders, easily soluble in water and alcohol, pH, respectively, 1.05 and 0.93. Both samples gave positive re-sults for the reaction of authenticity: the characteristic smell of trimethylamine in the thermolysis reaction, blue crystalline precipitates in the com-plexation reaction, white curd precipitates in the deposition reaction. The quantitative content of betaine hydrochloride in terms of dry matter in the test sample was 99.2%, in the standard sample - 99.9%. The possibility of obtaining betaine hydrochloride from domestic secondary raw materials with a large technological output, its identity with the standard sample create the prospect of import substitution of drugs based on betaine.

Keywords: 
post-alcohol corn bard
betaine hydrochloride
acidin
analytical characteristics

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