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Preparation method of linagliptin intermediate

An intermediate and system technology, which is applied in the field of preparation of the intermediate of hypoglycemic drug linagliptin, can solve the problems of complex production process, difficult subsequent purification process, increased production cost, etc., achieves improved yield and purity, and reduced production Cost and effect of shortening response time

Active Publication Date: 2019-05-03
THE SECOND PEOPLES HOSPITAL OF SHENZHEN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The above-mentioned preparation processes all have problems such as complicated production process, low purity of intermediates and products, difficult follow-up purification process, increased production cost, etc., which limit the industrial production of the drug

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] 8-bromo-7-(2-butynyl)-3,7-dihydro-3-methyl-1H-purine-2,6-dione 100mmol and 2-chloromethyl-4-methylquin Add 120mmol of oxazoline to 300mL of N-methylpyrrolidone, add 200mmol of potassium carbonate and 2.5mL of PEG400, stir and react at 50°C for 5 hours to obtain a reaction mixture, and add (R)-3-tert Butoxycarbonylaminopiperidine 120mmol, stirred and reacted at 60°C for 8 hours, the reaction was completed, 500mL of water was added to the reaction liquid, and the solid was precipitated, filtered, the wet filter cake was dissolved in dichloromethane, washed with water, dried with anhydrous sodium sulfate, filtered , concentrated under reduced pressure, added n-hexane, precipitated solid, filtered, and dried to obtain linagliptin intermediate 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7 -(2-butyn-1-yl)-8-[(R)-3-(tert-butoxycarbonylamino)-piperidin-1-yl]-2,6-dione-2,3,6, 7-tetrahydro-1H-purine, the yield is 93.3%, and the purity is 99.5%.

Embodiment 2

[0023] 8-bromo-7-(2-butynyl)-3,7-dihydro-3-methyl-1H-purine-2,6-dione 100mmol and 2-chloromethyl-4-methylquin Add 120mmol of oxazoline to 200mL of N-methylpyrrolidone and 100mL of acetonitrile, add 200mmol of potassium carbonate and 2.5mL of PEG400, stir and react at 50°C for 6 hours to obtain a reaction mixture, and add (R)- 3-tert-butoxycarbonylaminopiperidine 120mmol, stirred and reacted at 60°C for 8 hours, the reaction was completed, 500mL of water was added to the reaction solution, and the solid precipitated, filtered, and the wet filter cake was dissolved in dichloromethane, washed with water and then washed with anhydrous sodium sulfate Dry, filter, concentrate under reduced pressure, add n-hexane, precipitate a solid, filter, and dry to obtain linagliptin intermediate 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl Base-7-(2-butyn-1-yl)-8-[(R)-3-(tert-butoxycarbonylamino)-piperidin-1-yl]-2,6-dione-2,3 , 6,7-tetrahydro-1H-purine, the yield was 95.1%, and the purity was...

Embodiment 3

[0025] 8-bromo-7-(2-butynyl)-3,7-dihydro-3-methyl-1H-purine-2,6-dione 100mmol and 2-chloromethyl-4-methylquin Add 120mmol of oxazoline to 300mL of N-methylpyrrolidone, add 200mmol of potassium carbonate and 1.5mL of PEG400, stir and react at 60°C for 8 hours to obtain a reaction mixture, and add (R)-3-tert Butoxycarbonylaminopiperidine 120mmol, stirred and reacted at 60°C for 8 hours, the reaction was completed, 500mL of water was added to the reaction liquid, and the solid was precipitated, filtered, the wet filter cake was dissolved in dichloromethane, washed with water, dried with anhydrous sodium sulfate, filtered , concentrated under reduced pressure, added n-hexane, precipitated solid, filtered, and dried to obtain linagliptin intermediate 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7 -(2-butyn-1-yl)-8-[(R)-3-(tert-butoxycarbonylamino)-piperidin-1-yl]-2,6-dione-2,3,6, 7-tetrahydro-1H-purine, the yield is 89.6%, and the purity is 99.2%.

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Abstract

The invention provides a preparation method of linagliptin intermediate (1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-[(R)-3-(tert-butoxycarbonylamino)-piperidino-1-yl]-2,6-dione-2,3,6,7-tetrahydro-1H-purine) for treating type II diabetes. The method comprises the following steps: performing a reaction on 8-bromo-7-(2-butynyl)-3,7-dihydro-3-methyl-1H-purin-2,6-dione and 2-chloromethyl-4-methyl quinazoline in an organic solvent in the presence of potassium carbonate and PEG, adding (R)-3-tert-butoxycarbonylaminopiperidine into the reaction mixture, and performing a reactionto prepare the intermediate compound. According to the method provided by the invention, the yield and purity are improved, the reaction cycle is shortened, the production costs are reduced, and guarantee is provided for finally-obtained high-purity linagliptin.

Description

technical field [0001] The invention belongs to the field of chemical pharmacy, and in particular relates to a preparation process of an intermediate of a hypoglycemic drug linagliptin. technical background [0002] Linagliptin (English name is Linagliptin), chemical name is [(3R)-3-amino-1-piperidinyl]-7-(2-butynyl)-3,7-dihydro-3-methyl Base-1-[(4-methyl-2-quinazolinyl)methyl]-1H-purine-2,6-dione. Linagliptin is an 8-(3-aminopiperidine)-xanthine derivative WO 2004018468 developed by Boehringer Ingelheim, Germany; it is a very active dipeptidyl peptidase-4 (DPP-4 ) inhibitors, which are highly selective, long-acting and orally effective, and have good safety and tolerance. The drug was approved by the US FDA in May 2011 for the treatment of type 2 diabetes. Diet control and physical exercise improve glycemic control in adults with type 2 diabetes mellitus (T2DM). Compared with other gliptins, linagliptin has excellent renal safety. It does not require dose adjustment for...

Claims

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Application Information

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IPC IPC(8): C07D473/04
Inventor 谭回李维平
Owner THE SECOND PEOPLES HOSPITAL OF SHENZHEN