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A kind of metformin hydrochloride, production method technology, applied in the field of pharmaceutical chemical synthesis
Inactive Publication Date: 2015-07-22
TAISHAN MEDICAL UNIV
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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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Embodiment 1
[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 to raise the temperature of the synthesis kettle to 75°C.
[0058] (5) Secondary adjustment of vacuum degree
[0059] Adjust the vacuum degree in the synthesis kettle to be 0.06MPa.
[0060] (6) Secondary stirring
[0061] After the vacuum degree is stable, the stirring speed is adjusted to 80 rpm, and the stirring...
Embodiment 2
[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.
Embodiment 3
[0097] Solvent and solute are added into the synthesis kettle step, the solvent used is the mother liquor produced in the drying step of Example 3, put into the centrifuge from the synthesis kettle, continue to reuse, and add 100Kg of N-methylpyrrolidone and suck it into the synthesis kettle. Metformin hydrochloride was prepared according to the method of Example 1.
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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 cardiovascu...
Claims
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Application Information
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