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GMDTC drug impurity and preparation method thereof

An impurity and drug technology, applied in the field of GMDTC drug impurities and its preparation, can solve the problems of toxic and side effects, affecting drug efficacy, affecting the purity of GMDTC drugs, etc. Effect

Pending Publication Date: 2021-12-28
健尔圣(珠海)医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the impurities introduced or produced during the production and storage of GMDTC not only affect the purity of GMDTC drugs, but also affect the efficacy of drugs and may lead to toxic and side effects
However, there are no reports of GMDTC drug impurities

Method used

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  • GMDTC drug impurity and preparation method thereof
  • GMDTC drug impurity and preparation method thereof
  • GMDTC drug impurity and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0062] The preparation method of the GMDTC drug impurity of the present embodiment, comprises the following steps:

[0063] (1) Add 200mL of methanol into a 500mL three-necked flask, and add 20g of sodium hydroxide with stirring, and stir until the solid is basically dissolved completely;

[0064] (2) Add 74.5g of L-methionine, stir until the solid is basically dissolved completely; add 90g of D-(+)-glucose at one time, and react at 25°C for 6h;

[0065] (3) Cool down to 0°C, add 100mL of water dropwise; add 37g of sodium borohydride in batches, control the temperature at 30°C for 10-20h;

[0066] (4) Cool down to 0°C, add hydrochloric acid to adjust the pH of the system to 1; crystallize at room temperature, filter, and wash the filter cake; dry, recrystallize, dry, and collect 71.04 g of white solid;

[0067] (5) Add 300 mL of purified water and 31.3 g of the white solid obtained in step (4), stir, add 62.6 g of sodium carbonate at room temperature, and stir until the solid...

Embodiment 2

[0071] The preparation method of the GMDTC drug impurity of the present embodiment, comprises the following steps:

[0072] (1) Add 250mL of methanol into a 500mL three-neck flask, and add 20g of sodium hydroxide with stirring, and stir until the solid is basically dissolved completely;

[0073] (2) Add 74.5g of L-methionine, stir until the solid is basically dissolved completely; add 100g of D-(+)-glucose at one time, and react at 30°C for 15h;

[0074] (3) Cool down to 5°C, add 100mL of water dropwise; add 50g of sodium borohydride in batches, and react at 35°C for 15h;

[0075] (4) Cool down to 2°C, add hydrochloric acid to adjust the pH of the system to 2; crystallize at room temperature, filter, and wash the filter cake; dry, recrystallize, dry, and collect 82.15 g of white solid;

[0076] (5) Add 300 mL of purified water and 31.3 g of the white solid obtained in step (4), stir, add 70 g of sodium carbonate at room temperature, and stir until the solid dissolves complete...

Embodiment 3

[0080] The preparation method of the GMDTC drug impurity of the present embodiment, comprises the following steps:

[0081] (1) Add 300mL of methanol into a 500mL three-neck flask, and add 20g of sodium hydroxide with stirring, and stir until the solid is basically dissolved completely;

[0082] (2) Add 74.5g of L-methionine, stir until the solid is basically dissolved completely; add 120g of D-(+)-glucose at one time, and react at 35°C for 24h;

[0083] (3) Cool down to 10°C, add 100mL of water dropwise; add 74g of sodium borohydride in batches, and react at 40°C for 20h;

[0084] (4) Cool down to 5° C., add hydrochloric acid to adjust the pH of the system to 3; crystallize at room temperature, filter, and wash the filter cake; dry, recrystallize, and dry to obtain 80.19 g of white solid;

[0085] (5) Add 300 mL of purified water and 31.3 g of the white solid obtained in step (4), stir, add 75 g of sodium carbonate at room temperature, and stir until the solid dissolves comp...

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Abstract

The invention discloses a GMDTC drug impurity. The structure of the GMDTC drug impurity is shown as a formula (I). The invention further provides a preparation method of the GMDTC medicine impurity; the impurity can be used as an impurity standard substance or reference substance in GMDTC raw material medicine or preparation detection, and the quality of a GMDTC preparation is improved, so that the use safety and effectiveness of the GMDTC preparation are ensured.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical impurities, in particular to a GMDTC pharmaceutical impurity and a preparation method thereof. Background technique [0002] N-(2,3,4,5,6-pentahydroxyhexyl) N-(sodium dithioformate)-sodium methionine, referred to as GMDTC, is based on dithiocarbamate (DTC), using A new compound synthesized by replacing DTC with glucosamine-methylthioamino group, replacing R1 with methionine, and replacing R2 with D-glucosamine group. Studies have shown that GMDTC has a good effect of driving cadmium, and can effectively penetrate the cell membrane and enter the cell. GMDTC has a good cadmium repelling effect on acute cadmium poisoning, can greatly reduce renal cadmium, and has a good protective effect on cadmium nephrotoxicity. However, the impurities introduced or produced during the production and storage of GMDTC not only affect the purity of GMDTC drugs, but also affect the efficacy of drugs and may l...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D263/16G01N30/02G01N30/34G01N30/86
CPCC07D263/16G01N30/02G01N30/34G01N30/8679
Inventor 唐小江胡伟唐季歆钟志勇
Owner 健尔圣(珠海)医药科技有限公司
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