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Production method of high-purity metformin hydrochloride

A high-purity metformin hydrochloride technology, applied in the field of chemistry, can solve the problems of low yield, difficulty in reaching medical standards, and inability to guarantee purity, and achieves the effects of good product quality, low cost, and high product yield

Inactive Publication Date: 2014-10-29
徐晓宁
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] Since dicyandiamide begins to decompose above 80°C, the purity of metformin hydrochloride synthesized above 90°C cannot be guaranteed at all. The determination of the content in the existing metformin hydrochloride standard uses neutralization titration method to cover up impurities In this case, dicyandiamide and ammonium chloride have become legal content fillers, and there is no requirement for the impurity content of dimethylamine and tetracyanamide, and the applicable safety of the product cannot be guaranteed at all.
[0015] Although metformin hydrochloride has been produced by many manufacturers in China, there are still problems such as low yield and difficulty in reaching medical standards in purity.

Method used

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  • Production method of high-purity metformin hydrochloride

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Step 1: Put 1000 kg of cyclohexanol into the first 3000L jacketed enamel kettle 1, and feed steam to 75-90°C under stirring. Add 200 kg of solid dicyandiamide under stirring, keep the temperature and stir until completely dissolved.

[0036] In the second jacketed enamel kettle 2 of 2000L, put 800 kg of cyclohexanol into it, and feed steam to 75-90°C under stirring. Add 200 kg of solid dimethylamine hydrochloride under stirring, keep the temperature and stir until completely dissolved.

[0037] Step 2: Slowly add the materials in the second jacketed enamel kettle 2 to the first jacketed enamel kettle 1 for about 1.5 hours, and keep the temperature in the jacketed enamel kettle at 75-90 ℃. After the dropwise addition was completed, the insulation reaction was continued for 0.5 hour.

[0038] Step 3: Move the reaction material obtained in step 2 to the cleaner 3 with a rubber jacket, pass cooling water into the jacket, and continuously stir and cool down. When the temp...

Embodiment 2

[0042] Step 1: Put 1000 kg of the mother liquor of Example 1 into the first 3000L jacketed enamel kettle 1, and feed steam to 75-90°C under stirring. Add 168 kg of solid dicyandiamide under stirring, keep the temperature and stir until completely dissolved.

[0043] In the second jacketed enamel kettle 2 of 2000L, 800 kg of the mother liquor of Example 1 was dropped into, and steam was introduced to 75-90° C. under stirring. Add 163 kg of solid dimethylamine hydrochloride under stirring, keep the temperature and stir until completely dissolved.

[0044] Step 2: Slowly add the material in the second jacketed enamel kettle 2 to the first jacketed enamel kettle 1 for about 1.5 hours, and keep the temperature in the first jacketed enamel kettle 1 75~90℃. After the dropwise addition was completed, the insulation reaction was continued for 0.5 hour.

[0045] Step 3: Move the reaction material obtained in Step 2 to a crystallizer with a rubber jacket, pour cooling water into the j...

Embodiment 3

[0049] Put the mother liquor of Example 2 into the first jacketed enamel kettle 1, add 10 kg of activated carbon, heat and stir at 90°C, filter, then use it as a solvent, and repeat the operation of Example 2 to obtain metformin hydrochloride Weighing, 303.2 grams, yield 91.6%, sampling analysis, melting point 224.1 ~ 225.2 ° C, in line with medical standards.

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Abstract

The invention discloses a production method of high-purity metformin hydrochloride. The method comprises the following steps: heating a solvent to a temperature of 75 to 90 DEG C, adding solid dicyandiamide under stirring, maintaining the solvent temperature in a range of 75 to 90 DEG C, dropwise adding a dimethylamine hydrochloride solution to carry out reactions at the temperature of 75 to 90 DEG C, wherein during the reaction process, crystals are gradually generated; stopping stirring after the reactions have been carried out for a while, cooling until the temperature reaches 25 to 30 DEG C, filtering, and drying the crystals so as to obtain the metformin hydrochloride product, wherein the mother liquor can be recycled. The technology has the advantages of high purity and low cost.

Description

technical field [0001] The invention belongs to the technical field of chemistry and relates to a method for producing high-purity metformin hydrochloride. Background technique [0002] Metformin hydrochloride is an unsatisfactory type II diabetes drug for the treatment of simple diet control, especially for obese patients with hyperinsulinemia. Its pharmacological mechanism is different from other oral hypoglycemic drugs. Metformin reduces hepatic gluconeogenesis, reduces intestinal glucose absorption, and improves insulin sensitivity by increasing glucose uptake and utilization in peripheral tissues. Unlike sulfonylureas, metformin does not produce hypoglycemia and does not cause hyperinsulinemia in both type 2 diabetic patients and normal subjects. Treatment with metformin may reduce fasting insulin levels and the whole-day plasma insulin response, but usually there is no change in insulin secretion. [0003] A brief description of previous technologies is as follows: ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07C279/26C07C277/08
Inventor 徐晓宁赵岩赵宝超张智孙壮
Owner 徐晓宁
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