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Salting-out and solvating-out crystallization method for citicoline

A technology of citicoline and starting citicoline, which is applied in the field of crystallization of citicoline, can solve problems such as low yield and poor product quality, achieve good repeatability, short operation time, Reduces the effect of increased pigment impurities

Active Publication Date: 2009-09-23
NANJING HIGH TECH UNIV BIOLOGICAL TECH RES INST CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The technical problem to be solved by the present invention is to provide a crystallization method of citicoline, which uses the salting-out compound crystallization technology to replace the existing solvent strong analysis technology, so as to overcome the existing crystallization technology of citicoline The disadvantages of poor product quality and low yield

Method used

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Examples

Experimental program
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Effect test

Embodiment 1

[0021] Adjust 10 L of citicoline aqueous solution with a concentration of 10 g / L to pH 5.0 with hydrochloric acid, add 3 g of sodium chloride and 10 L of eluent methanol, and control the stirring speed at 10°C to 100 rpm. After the crystallization is complete, the suspension is suction-filtered, the white crystals obtained are washed with 85% ethanol, and vacuum-dried to obtain 95.1 g of citicoline sodium salt crystals with a crystallization yield of 95.1% and a purity of 99.2%.

Embodiment 2

[0023] Adjust 4 L of citicoline aqueous solution with a concentration of 200 g / L to pH 8.0 with hydrochloric acid, add 40 g of sodium carbonate and 10 L of ethanol as eluting agent, and control the stirring speed at 230 rpm at 35°C. After the crystallization was complete, the suspension was filtered with suction, the resulting white crystals were washed with 85% ethanol, and vacuum-dried to obtain 772 g of citicoline sodium salt crystals with a crystallization yield of 96.5% and a purity of 99.5%.

Embodiment 3

[0025] Adjust 2 L of citicoline aqueous solution with a concentration of 400 g / L to pH 8.0 with hydrochloric acid, add 80 g of sodium acetate and 6 L of acetone as a dissolving agent, and control the stirring speed at 40°C to 80 rpm. After the crystallization was complete, the suspension was filtered with suction, the resulting white crystals were washed with 85% ethanol, and vacuum-dried to obtain 762 g of citicoline sodium salt crystals with a crystallization yield of 95.25% and a purity of 99.1%.

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Abstract

The invention discloses a salting-out and solvating-out crystallization method for citicoline. The method comprises the following steps: adding inorganic sodium salt which accounts for 1 to 20 percent of citicoline and a solvating agent which is 1.0 to 4.0 times the volume of a staring citicoline aqueous solution to a citicoline aqueous solution with a pH value between 5.0 and 8.0 and a concentration between 10 and 400 g / L; stirring the materials at a rotating speed controlled between 20 and 230 rpm at a temperature of between 10 and 40 DEG C; performing pumping filtration after complete crystallization; washing the obtained product with ethanol; drying the obtained product in vacuum; and obtaining the citicoline sodium salt crystals with the purity higher than 99 percent. The method has the advantages that the method obviously improves the quality of final products, raises crystallization yield stability, can control the particle size of the crystals by changing crystallization temperature or the states of a flow field, and is simple to operate, good in repeatability and suitable for the industrial production of the citicoline.

Description

technical field [0001] The invention belongs to the field of biological product processing, and in particular relates to a crystallization method of citicoline. Background technique [0002] Citicoline, also known as cytidine-5'-diphosphate choline (Cytidine-5'-diphosphate choline, CDP-C, CDP-choline), is an important precursor of phospholipid metabolism and is necessary for lecithin biosynthesis The coenzyme is an intermediate in the synthesis of phosphatidylcholine, and has a significant effect on central nervous system damage models and encephalopathy. Its pharmacological effects are: a. Promote the synthesis of lecithin; b. Inhibit the decomposition of lecithin under cerebral ischemia; c. Improve the glucose metabolism during cerebral ischemia; d. Improve the energy metabolism of brain cells and prevent cerebral edema; e. . Reduce hyperlipidemia and platelet viscosity, dilate small arteries, improve microcirculation; f. By affecting the function of transmitters or recep...

Claims

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Application Information

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IPC IPC(8): C07H19/10A61P9/00
Inventor 应汉杰张磊杜振兴熊健李振江柏建新欧阳平凯
Owner NANJING HIGH TECH UNIV BIOLOGICAL TECH RES INST CO LTD
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