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Preparation of mitiglinide calcium and its quality control method

A technology of mitiglinide calcium and quality is applied in the field of preparation and detection of hypoglycemic drugs, and can solve the problems of complex synthesis route, unsuitability for industrialized production, low yield and the like

Inactive Publication Date: 2006-10-11
天津汉康医药生物技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Drugs of the Future 2000, 25 (10) also introduced a method for preparing mitiglinide calcium. These methods have complicated synthetic routes, low yield, inconvenient operation and harsh conditions, and are not suitable for industrial production

Method used

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  • Preparation of mitiglinide calcium and its quality control method
  • Preparation of mitiglinide calcium and its quality control method
  • Preparation of mitiglinide calcium and its quality control method

Examples

Experimental program
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Embodiment 1

[0084] Step 1, the synthesis of cis-cyclohexyl-1,2-dicarboximide

[0085] Tetrahydroimine (30 g, 199 mmol) was dissolved in methanol (1000 ml), 10% Pd / C (0.3 g) was added, hydrogen was passed through, stirred at room temperature for 28 hours until no hydrogen was absorbed, filtered, and the filtrate was concentrated to obtain white crystals. The mass is: 30.2g; the yield is: 99.3%.

[0086] Step 2, the synthesis of cis-hexahydroisoindole

[0087] Lithium aluminum hydride (18.6g, 490mmol) was added to dry tetrahydrofuran (150ml), and a solution of cis-cyclohexyl-1,2-dicarboximide (30g, 196mmol) in tetrahydrofuran (500ml) was added dropwise with stirring , The rate of addition was to keep the tetrahydrofuran solution slightly refluxed. After all the addition, the reaction solution was refluxed for 30 hours, cooled, and a small amount of water was added to decompose the excess aluminum tetrahydrogen lithium, the resulting precipitate was filtered, the filtrate was concentrated,...

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Abstract

The invention relates to a preparation and quality control method of Mitiglinide Calcium comprising steps: 1,synthesis of cis- cyclohexyl-1,2-dimethylacid imide; 2,synthesis of cis-hexa-hydrogen isoindole; 3,synthesis of alpha-benzyldiethyl malonate; 4,synthesis of benzylsuccinic acid; 5,S- benzylsuccinic acid methylbenzylamine salt; 6,synthesis of s- benzylsuccinic acid; 7,synthesis of (2S)-2- benzyl-3-(cis-hexa-hydrogen isoindole-2- carbonyl) propanoic acid; 8,synthesis of Mitiglinide Calcium; 9,purity of Mitiglinide Calcium. This invention also contains the method for quality control of Mitiglinide Calcium comprising steps: watching deseription, messureing specific rotation, authenticating, checking, content messureing for Mitiglinide Calcium.

Description

technical field [0001] The invention relates to a preparation and detection method of a hypoglycemic drug, in particular to a preparation and quality control method of mitiglinide calcium. Background technique [0002] Diabetes is a common and frequently-occurring disease, and the number of its patients is increasing rapidly with the improvement of people's living standards, population aging, changes in lifestyle, and advances in diagnostic techniques. According to the relevant data of WHO, the prevalence rate, disability rate, mortality rate and degree of harm of diabetes rank the third among non-communicable diseases, and it has become the third serious threat to human health after cardiovascular and cerebrovascular diseases and tumors. The three major diseases not only bring great suffering to patients, greatly affect the quality of life, but also bring a heavy economic burden to the society. [0003] At present, oral hypoglycemic agents clinically used for the treatment...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D209/08A61K31/404A61P3/10G01N21/82G01N21/35G01N33/02G01N21/3563
Inventor 严洁
Owner 天津汉康医药生物技术有限公司
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