Production method for producing metformin hydrochloride

A technology of metformin hydrochloride and a production method, which is applied in the directions of organic chemistry methods, chemical instruments and methods, preparation of organic compounds, etc., can solve the problems of low yield, increased production cost, low purity of metformin hydrochloride impurities, and impact on the quality of metformin hydrochloride finished products, etc. problems, to achieve the effect of improving quality and yield, reducing impurities and improving quality

Inactive Publication Date: 2020-11-10
SHIJIAZHUANG POLEE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The production route that this medicine usually adopts is, synthesize dimethylamine hydrochloride by dimethylamine, hydrochloric acid, then synthesize metformin hydrochloride crude product by dimethylamine hydrochloride and dicyandiamide, although this production process can meet the production of metformin hydrochloride, but The metformin hydrochloride impurity purity that production obtains is not high, thereby has influenced the finished product quality of metformin hydrochloride, and the low yield has increased production cost

Method used

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  • Production method for producing metformin hydrochloride

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Embodiment 1

[0031] refer to figure 1 , a production method for producing metformin hydrochloride, comprising the synthesis, crystallization and refining of metformin hydrochloride crude product.

[0032] The synthesis of metformin hydrochloride crude product comprises the following steps: pump the dimethylamine hydrochloride solution in the salt forming tank into the synthesis tank through vacuum, evaporate the material to dryness at 120°C, then add 600kg of dicyandiamide, control the steam at ≥0.4Mpa, and the reaction temperature 140°C, react for 4 hours, pass circulating water to cool down to 105°C, add 2500kg of purified water, heat to 50°C, keep stirring for 1 hour, and let stand for 30 minutes.

[0033] The preparation of dimethylamine hydrochloride solution comprises the following steps: add 920 kg of dimethylamine into the dimethylamine hydrochloride salt forming tank through the dimethylamine metering tank, cool the temperature of the tank interlayer with cold brine, start stirrin...

Embodiment 2

[0049] refer to figure 1 , a production method for producing metformin hydrochloride, comprising the synthesis, crystallization and refining of metformin hydrochloride crude product.

[0050] The synthesis of metformin hydrochloride crude product comprises the following steps: pump the dimethylamine hydrochloride solution in the salt forming tank into the synthesis tank through vacuum, evaporate the material to dryness at 120°C, then add 600kg of dicyandiamide, control the steam at ≥0.4Mpa, and the reaction temperature 140°C, react for 4 hours, pass circulating water to cool down to 105°C, add 2500kg of purified water, heat to 50°C, keep stirring for 1 hour, and let stand for 30 minutes.

[0051]The preparation of dimethylamine hydrochloride solution comprises the following steps: add 920 kg of dimethylamine into the dimethylamine hydrochloride salt forming tank through the dimethylamine metering tank, cool the temperature of the tank interlayer with cold brine, start stirring...

Embodiment 3

[0067] refer to figure 1 , a production method for producing metformin hydrochloride, comprising the synthesis, crystallization and refining of metformin hydrochloride crude product.

[0068] The synthesis of metformin hydrochloride crude product comprises the following steps: pump the dimethylamine hydrochloride solution in the salt forming tank into the synthesis tank through vacuum, evaporate the material to dryness at 120°C, then add 600kg of dicyandiamide, control the steam at ≥0.4Mpa, and the reaction temperature 140°C, react for 4 hours, pass circulating water to cool down to 105°C, add 2500kg of purified water, heat to 50°C, keep stirring for 1 hour, and let stand for 30 minutes.

[0069] The preparation of dimethylamine hydrochloride solution comprises the following steps: add 920 kg of dimethylamine into the dimethylamine hydrochloride salt forming tank through the dimethylamine metering tank, cool the temperature of the tank interlayer with cold brine, start stirrin...

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Abstract

The invention relates to the technical field of chemical synthesis, in particular to a method for producing metformin hydrochloride, and the method comprises the steps of synthesizing, crystallizing and refining a metformin hydrochloride crude product, and comprises the following steps: S1, transferring a solution containing the metformin hydrochloride crude product into a crystallizing tank for crystallizing; S2, in the crystallization process, heating the solution containing the metformin hydrochloride crude product to evaporate moisture, and then adding 86% ethanol for refining; S3, performing natural cooling for 2.5-3.5 hours, opening an interlayer circulating water valve of the crystallizing tank, introducing circulating water into the interlayer, and performing cooling to be less than or equal to 25 DEG C at a cooling rate of 2-5 DEG C / hour; S4, replacing with chilled water, and continuously performing cooling to be less than or equal to 10 DEG C at the cooling rate of 1-2 DEG C / h; S5, stopping stirring, standing for 4 hours, starting stirring for 8-15 minutes per hour during standing, starting stirring after standing is finished, opening a tank bottom valve, and preparing for centrifugal separation. According to the method, the purity and yield of the metformin hydrochloride finished product can be remarkably improved.

Description

technical field [0001] The invention relates to the technical field of chemical synthesis, in particular to a production method for producing metformin hydrochloride. Background technique [0002] Metformin hydrochloride is a drug for treating type Ⅱ diabetes. In addition to effectively lowering blood sugar, metformin hydrochloride can also reduce weight, protect cardiovascular system, and comprehensively control various metabolic abnormalities, making it different from other hypoglycemic drugs and becoming the first choice for diabetes treatment. Recognized by the medical field and patients all over the world. The market prospect is broad. The production route that this medicine usually adopts is, synthesize dimethylamine hydrochloride by dimethylamine, hydrochloric acid, then synthesize metformin hydrochloride crude product by dimethylamine hydrochloride and dicyandiamide, although this production process can meet the production of metformin hydrochloride, but The metfor...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07C277/08C07C279/26C07C277/06
CPCC07C277/08C07C277/06C07B2200/13
Inventor 刘胜昔秦晓辉秦建辉王晓东杨旭翠校军梅秦晓朋李品
Owner SHIJIAZHUANG POLEE PHARMA CO LTD
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