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Method for producing metformin hydrochloride large particle crystal

A technology of metformin hydrochloride and a production method, applied in chemical instruments and methods, preparation of organic compounds, organic chemistry and other directions, can solve the problems of small particle size, affecting product yield and cost, material loss, etc., and achieves large crystals and saves ethanol. Effect

Active Publication Date: 2009-06-10
JIANGSU DEYUAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The production route usually adopted by the drug is to synthesize dimethylamine hydrochloride from dimethylamine and hydrochloric acid, then synthesize metformin hydrochloride crude product from dimethylamine hydrochloride and dicyandiamide, and refine metformin hydrochloride crude product with 95% ethanol to obtain metformin hydrochloride product The particle size of the product is relatively small, and 95% of the products have a particle size of less than 100 mesh, which is relatively fluffy and cannot meet the requirements of relevant customers. It is not easy to filter and separate, which increases the operation time and difficulty, and easily causes material loss, affecting product yield and cost.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0009] Prepare 235Kg of industrial hydrochloric acid in the high-level tank, add 200Kg of dimethylamine into the reaction tank, start stirring, turn on the ice brine to cool down, close the vacuum, open the vent valve, start adding hydrochloric acid dropwise to PH=3, close and press back to the cooling brine, Turn on the vacuum, turn on the steam to heat and remove the water, until no moisture comes out. Then suck in 260Kg of isoamyl alcohol, turn off the vacuum, open the mouth of the reaction tank and add 150Kg of dicyandiamide, and cover the feeding port tightly. Turn on the steam to heat and reflux for 12 hours, turn off the steam valve, cool the condensed water to below 50°C, shake off the material, reclaim the mother liquor, wash the material with 43Kg of absolute ethanol, and obtain 280Kg of metformin hydrochloride crude product. Put the obtained metformin hydrochloride crude product and 840Kg of purified water 3 times its weight into a reaction tank, heat it to 65°C and...

Embodiment 2

[0011] Prepare 235Kg of industrial hydrochloric acid in the high-level tank, add 200Kg of dimethylamine into the reaction tank, start stirring, turn on the ice brine to cool down, close the vacuum, open the vent valve, start adding hydrochloric acid dropwise to PH=3, close and press back to the cooling brine, Turn on the vacuum, turn on the steam to heat and remove the water, until no moisture comes out. Then suck in 260Kg of isoamyl alcohol, turn off the vacuum, open the mouth of the reaction tank and add 150Kg of dicyandiamide, and cover the feeding port tightly. Turn on the steam to heat and reflux for 12 hours, turn off the steam valve, cool the condensed water to below 50°C, shake off the material, reclaim the mother liquor, wash the material with 45Kg of absolute ethanol, and obtain 279Kg of metformin hydrochloride crude product. Put the obtained metformin hydrochloride crude product and 837Kg of purified water 3 times its weight into a reaction tank, heat it to 75°C and...

Embodiment 3

[0013] Prepare 235Kg of industrial hydrochloric acid in the high-level tank, add 200Kg of dimethylamine into the reaction tank, start stirring, turn on the ice brine to cool down, close the vacuum, open the vent valve, start adding hydrochloric acid dropwise to PH=3, close and press back to the cooling brine, Turn on the vacuum, turn on the steam to heat and remove the water, until no moisture comes out. Then suck in 260Kg of isoamyl alcohol, turn off the vacuum, open the mouth of the reaction tank and add 150Kg of dicyandiamide, and cover the feeding port tightly. Turn on the steam to heat and reflux for 12 hours, turn off the steam valve, cool the condensed water to below 50°C, shake off the material, reclaim the mother liquor, wash the material with 46Kg of absolute ethanol, and obtain 285Kg of metformin hydrochloride crude product. Put the obtained metformin hydrochloride crude product and 855Kg of purified water 3 times its weight into a reaction tank, heat it to 70°C and...

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PUM

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Abstract

The invention provides a method for producing large-grained crystals of metformin hydrochloride in the technical field of chemical synthesis. The invention adopts a technical proposal that: a crude product of metformin hydrochloride obtained through synthesis of dimethylammonium chloride and dicyandiamide is firstly washed with absolute ethanol; after a parent liquid washed by ethanol is separated, the obtained crude product of metformin hydrochloride is put into a purified water of which the weight is three times of the weight of the crude product of metformin hydrochloride, heated to 65 to 75 DEG C for circumfluence, stirred to be cooled to 40 to 50 DEG C, and stood to be cooled to 20 DEG C, then the parent liquid is separated, and thus large-grained crystals of metformin hydrochloride is obtained. The granularity of 95 percent of the large-grained crystals of metformin hydrochloride exceeds 40 meshes, the large-grained crystals of metformin hydrochloride has a taste of edible monosodium glutamate, can meet the requirements of customers, and contributes to the reduction of production cost.

Description

technical field [0001] The invention belongs to the field of chemical synthesis, in particular to a production method of metformin hydrochloride large particle crystals. Background technique [0002] Metformin Hydrochloride (Metformin Hydrochloride) has strong physiological activity, and it is a hypoglycemic drug with definite curative effect for clinical use. It mainly acts on tissues outside the pancreas, inhibits the intestinal absorption of glucose, increases the utilization of glucose by peripheral tissues, and reduces hepatic gluconeogenesis, thereby achieving the effect of lowering blood sugar. Not only has a unique therapeutic effect on Type 2 diabetes, but pharmacological studies have proved that it can also significantly lower blood pressure and reduce glutathione in the blood and Mg in the liver. 2+ Concentration, has the function of protecting the liver. Therefore, metformin hydrochloride is a chemosynthetic substance with broad-spectrum therapeutic effects. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07C279/26C07C277/06C07C277/02
Inventor 马方兴仝翔
Owner JIANGSU DEYUAN PHARMA
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