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A kind of production method of high-purity metformin hydrochloride

A technology of metformin hydrochloride and its production method, which is applied in the field of synthesis of pharmaceutical chemicals, can solve problems such as difficult control of production operations, strict equipment material requirements, and large proportion of raw materials, and achieve shortened product refining cycle, fast drying speed, and raw material conversion rate-enhancing effect

Inactive Publication Date: 2016-10-05
TAISHAN MEDICAL UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The synthesis method has a simple process principle and a short production cycle, but still has the following disadvantages: (1) the reaction is incomplete, the raw materials in the early stage of the reaction are solid, and the finished product in the late stage of the reaction is solid, and there is only a short-term homogeneous reaction, and the reaction uniformity is poor. The proportion of raw materials in the reaction is large, which brings difficulties to subsequent refining; (2) The conversion rate of raw materials is low, the product yield is low, and the product benefit is poor; (3) There are potential safety hazards in production
The melting temperature of dicyandiamide and dimethylamine salt exceeds 160°C. When the two materials are higher than the melting point, the reaction speed is fast, which is basically an instantaneous reaction. The temperature rises rapidly in a short period of time, and flushing will occur; The material requirements are harsh, the equipment investment is too large, and the production operation is not easy to control
[0012] The existing technology produces metformin hydrochloride with low purity, low yield, long cycle, high cost, potential safety hazards, environmental pollution and other deficiencies in the production of metformin hydrochloride. In production, the most critical thing is the addition reaction of dicyandiamide and dimethylamine hydrochloride. The domestic and foreign research and application of dimethylamine hydrochloride preparation and finished product drying have become increasingly mature, and its research value is not as good as that of dicyandiamide. Addition reaction with dimethylamine hydrochloride

Method used

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  • A kind of production method of high-purity metformin hydrochloride
  • A kind of production method of high-purity metformin hydrochloride
  • A kind of production method of high-purity metformin hydrochloride

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] 1. Add solvent and solute to the synthesis kettle

[0048]The synthesis kettle used is a 1000L glass-lined kettle. The solvent N-methylpyrrolidone 600Kg is sucked into the synthesis kettle by vacuum, the stirring is started, and the solute dicyandiamide 250Kg and dimethylamine hydrochloride 250Kg are added.

[0049] 2. Stir

[0050] (1) Stirring for the first time

[0051] Open the steam valve, turn on the steam to raise the temperature, and use a frequency converter to adjust the stirring speed to 50-60 rpm.

[0052] (2) Second heating

[0053] Stir for 15-20 minutes to raise the temperature of the synthesis kettle to 62°C.

[0054] (3) Adjust the vacuum degree for the first time

[0055] Turn on the vacuum pump, adjust the vacuum degree in the synthesis kettle to 0.04MPa, and continue stirring for 10-20 minutes after the vacuum degree is stable.

[0056] (4) Three heating times

[0057] Open the large steam valve, continue to heat up, and stir for 15-20 minutes...

Embodiment 2

[0093] The preparation steps of Example 1 are adopted, and the solvent used is the mother liquor produced in the spin-drying step of Example 1, which is put into a centrifuge from the synthesis kettle and then reused to prepare metformin hydrochloride.

Embodiment 3

[0095] Using the preparation steps of Example 1, the solvent used is the mother liquor produced in the spin-drying step of Example 2, which is put into a centrifuge from the synthesis kettle and continued to be reused to prepare metformin hydrochloride.

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Abstract

The invention discloses a high-purity metformin hydrochloride preparation method. N-methyl pyrrolidone is used as a solvent, dicyandiamide and dimethylamine hydrochloride are taken as a solute, the solvent and the solute are added into a synthesis kettle for reaction, and metformin hydrochloride is prepared through steps of stirring, cooling, spin-drying, washing, crystallizing and drying. The metformin hydrochloride prepared through the preparation method provided by the invention has the advantages that the yield is higher than 96.4 percent, and the product purity is higher than 99.93 percent.

Description

technical field [0001] The invention belongs to the technical field of synthesis of medicinal chemicals, and in particular relates to a production method of metformin hydrochloride with high purity, high yield, low cost and environment friendliness. Background technique [0002] Metformin hydrochloride is a hypoglycemic agent for the treatment of non-insulin-dependent diabetes mellitus. It can improve the blood sugar tolerance of patients with type Ⅱ diabetes and reduce basal and postprandial blood sugar. Its characteristic is that it does not promote the secretion of insulin, but promotes the uptake of glucose by tissues. It has no obvious hypoglycemic effect on normal blood sugar, generally does not cause hypoglycemia, and is relatively safe. In the prevention and treatment of diabetes, metformin hydrochloride is used more and more widely and has become an irreplaceable oral hypoglycemic drug. Insulin resistance (IR) is one of the independent risk factors for cardiovascul...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07C277/08C07C279/26
CPCC07C277/08C07C279/26
Inventor 张恭孝孟宪锋任敬一杨荣华陈红余郭学阳杨明晖张秀玲吕俊峰李庆芝郭彦恺李强
Owner TAISHAN MEDICAL UNIV
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