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Stable crystal form of avibactam sodium and preparation method thereof

A crystal form and stable technology, applied in the field of drug-stabilized crystal form of Avibatana and its preparation, can solve problems such as being unsuitable for industrial production, and achieve the effect of high yield

Pending Publication Date: 2020-09-22
HAINAN HAILING CHEMIPHARMA CORP
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  • Abstract
  • Description
  • Claims
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AI Technical Summary

Problems solved by technology

[0004] This method uses a lot of column separation and is not suitable for industrial production

Method used

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  • Stable crystal form of avibactam sodium and preparation method thereof
  • Stable crystal form of avibactam sodium and preparation method thereof
  • Stable crystal form of avibactam sodium and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Example 1 Preparation of (1R,2S,5R)-7-oxo-6-sulfonyloxy-1,6-diazabicyclo[3,2,1﹞octane-2-carboxamide sodium salt

[0022] Add 2.25L absolute ethanol and 300g (1R,2S,5R)-7-oxo-6-sulfonyloxy-1,6-diazabicyclo﹝3,2,1﹞octane to a 5L reaction flask -Tributylbenzyl ammonium salt of 2-carboxamide, stir to dissolve, filter, heat the filtrate to 35-40°C, add 1.68L absolute ethanol, 120ml purified water, 184.4g ethylhexyl dropwise at 35-40°C Sodium acid solution. After the dropwise addition, a solid was precipitated, then the temperature was lowered to 15-25° C., stirring and crystallization was continued for 4 h, and a white solid was obtained by filtration and drying, with a yield of 70-80%.

[0023] Record the X-ray diffraction pattern in the attached figure 1 middle.

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Abstract

The invention discloses an effective stable crystal form of avibactam sodium ((1R, 2S, 5R)-7-oxo-6-sulfonyloxy-1, 6-diazabicyclo(3, 2, 1)octane-2-formamide sodium salt) and a preparation method. The crystal form compound is a drug stable crystal form and has a wide application prospect.

Description

technical field [0001] The invention relates to a drug stable crystal form of avibactaner and a preparation method thereof. Background technique [0002] Ceftazidime Avibactam for injection was the first Actavis listed on the FDA in February 2015, under the trade name Avycaz. Compound patents CN1289500C, CN103649051B, and CN105294690B disclose a method for preparing Avibatana. The basic route of the method is as follows: [0003] [0004] This method has used a lot of column separation, is not suitable for industrialized production. Contents of the invention [0005] The purpose of the present invention is to provide a stable crystal form of avibactam sodium medicine and a preparation method thereof, which is widely used, and the main contents of the invention are as follows:. [0006] A drug stable crystal form of Avibactaner, characterized in that its X-ray diffraction pattern has 5 characteristic peaks at 2θ13.0±0.5, 16.5±0.5, 17.3±0.5, 17.5±0.5, and 22.4±0.5, And...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D471/08
CPCC07D471/08C07B2200/13
Inventor 蔡亲路国荣韩勇王远景
Owner HAINAN HAILING CHEMIPHARMA CORP
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