Stable edaravone trihydrate and pharmaceutical compositions thereof

A technology of hydrate and edaravone, which is applied in the field of medicine, can solve the problems such as difficult dissolution of edaravone, and achieve the effect of simple method, high yield and good stability
CN103483262AInactive Publication Date: 2014-01-01TIANJIN SONGRUI MEDICAL TECH
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Patent Information

Authority / Receiving Office
CN · China
Current Assignee / Owner
TIANJIN SONGRUI MEDICAL TECH
Publication Date
2014-01-01
Estimated Expiration
Not applicable · inactive patent

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Abstract

The invention belongs to the technical field of medicine, and provides stable edaravone trihydrate, edaravone trihydrate pharmaceutical compositions for injection, a method for preparing the edaravone trihydrate and a method for preparing the edaravone trihydrate pharmaceutical compositions. Crude edaravone trihydrate is stirred and dissolved in an ethyl alcohol-pure water solution, the pH value is adjusted through hydrochloric acid to range from 3 to 5, and then liquor formed by mixing ethers and ketone according to the volume ratio of 1:(1-4) is added to the solution, and stirring and crystallization are carried out; filtering, collecting, washing and vacuum drying are carried out to obtain the edaravone trihydrate which is high in yield and purity and stable in quality. The edaravone trihydrate pharmaceutical compositions, for injection, prepared according to the preparation formulation and the preparation technology are stable in quality and can be easily employed in an industrialized mode.
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Description

technical field

[0001] The invention relates to the field of medicine, in particular to a stable edaravone trihydrate and a pharmaceutical composition thereof. Background technique

[0002] Edaravone

[0003] Chemical name: 3-Methyl-1-phenyl-2-pyrazolin-5-one (3-Methyl-1-phenyl-2-pyrazolin-5-one);

[0004] Molecular formula: C 10 h 10 N 20 ;

[0005] Molecular weight: 174.20;

[0006] Structural formula:

[0007] Since the main ring of Edaravone is a five-membered ring ketone, the carbonyl group is adjacent to N, and the N at position 2 is connected to an unsaturated bond, which is easy to oxidize, so the molecular structure is very unstable, and it will be oxidized to There is no active substance, and it is easy to produce high molecular impurities, which will cause harm to the human body. In addition, because there are no hydrophilic groups such as hydroxyl and carboxyl in the structure, and methyl and phenyl are insoluble in water, the long-term dissolution pro...

Claims

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