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Preparation method of high-purity glimepiride

A high-purity, ethyl-based technology, applied in organic chemistry methods, organic chemistry and other directions, to achieve the effect of sufficient research on impurities, meeting the needs of use, and high yield

Active Publication Date: 2020-03-17
江苏海悦康医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, there is no glimepiride production process that can produce high purity, high yield, correct crystal form and good preparation product quality.

Method used

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  • Preparation method of high-purity glimepiride
  • Preparation method of high-purity glimepiride
  • Preparation method of high-purity glimepiride

Examples

Experimental program
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Embodiment

[0030] A kind of preparation method of high-purity glimepiride, concrete steps are as follows:

[0031] Step 1, preparation of 3-ethyl-4-methyl-2-oxo-N-phenethyl-2,5-dihydro-1H-pyrrole-1-amide: pre-dehydration of toluene, molecular sieve preservation, the Toluene, 3-ethyl-4-methyl-3-pyrroline-2-one and 2-phenylethyl isocyanate were added to a three-necked flask, and the temperature was raised to reflux under nitrogen replacement, and the reaction was monitored by HPLC for about 4 hours. Slightly lower the temperature of the reaction product, and concentrate under reduced pressure at a water bath temperature of 50°C to remove toluene. After concentration to dryness, add acetone, stir at room temperature for 1 hour, cool down to about 0°C and crystallize for 2-3 hours, filter, and use as a filter cake. Rinse with a small amount of n-heptane and drain it, and dry it in a 45°C oven under reduced pressure to obtain 3-ethyl-4-methyl-2-oxo-N-phenylethyl-2,5-dihydro-1H -Pyrrole-1-ami...

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Abstract

The invention discloses a preparation method of high-purity glimepiride. The preparation method comprises the following specific steps: 1, adding 1-[4-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)-ethyl]-benzenesulfonamide and potassium carbonate into a mixed solvent, and raising the temperature to dissolve the added substances; and 2, carrying out cooling crystallization on a solution obtained in step 1, and filtering the cooled solution to obtain 1-[4-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)-ethyl]-benzenesulfonyl]-3-(trans-4-methylcyclohexyl)-urea. The glimepiride obtained by the preparation method has a purity of above 99.9% and a high yield, impurity research is sufficient and controllable, the crystal form is correct, and the preparation product quality is good,so the use requirements of people are met.

Description

technical field [0001] The invention relates to the field of medicine preparation, in particular to a preparation method of high-purity glimepiride. Background technique [0002] The pharmaceutical industry is an important part of my country's national economy. It is a combination of traditional industries and modern industries. The pharmaceutical industry plays an important role in protecting and improving people's health and improving the quality of life. has a very important role. Medical workers have devoted themselves to research on drugs and developed many drugs to treat human diseases, and glimepiride is one of them. [0003] The chemical name of glimepiride is 1-[4-[2-(3-ethyl-4-methyl-2-oxo-3-pyrroline-1-carboxamido)-ethyl]-benzenesulfonyl ]-3-(trans-4-methylcyclohexyl)-urea, the structural formula is as follows: [0004] [0005] Glimepiride is a sulfonylurea hypoglycemic drug developed by Hoechst in Germany. Glimepiride was launched in Sweden in 1995 under t...

Claims

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Application Information

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IPC IPC(8): C07D207/38
CPCC07D207/38C07B2200/07C07B2200/13
Inventor 姜春阳李惠谢荣光裴欣宇
Owner 江苏海悦康医药科技有限公司
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