FIELD: medicine, pharmaceutics.
SUBSTANCE: invention refers to a method for producing 3-(2,2,2-trimethylhydrazinium)propionate dihydrate (Meldonium) complying with purity requirements from a pharmacopoeial point of view and storage-stable. The presented method for producing Meldonium can be implemented industrially at pharmaceutical factories. The method involves alkaline hydrolysis of 3-(2,2,2-trimethylhydrazinium)propionate ester and electrodialysis purification of organic products, wherein the hydrolysis procedure is performed in a heterophased (immiscible) system of an aqueous solution of organic products and an aqueous solution of inorganic salts by a reaction of potassium phosphates, dibasic and tribasic at pH 12-13 and temperature 20-40°C; that is followed by layering and performing the electrodialysis purification of the Meldonium solution to remove residual amounts of inorganic salts; thereafter Meldonium is recovered by known methods.
EFFECT: high-yield recovery of Meldonium complying with purity requirements from a pharmacopoeial point of view.
7 cl, 2 tbl, 16 ex
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Authors
Dates
2015-08-10—Published
2014-07-14—Filed