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Preparation method of edaravone injection

A technology for edaravone and injection, which is applied in the field of preparation of edaravone injection, can solve problems such as potential safety hazards, unsuitability for clinical application and the like, and achieve the effect of improving stability

Active Publication Date: 2018-03-23
YANGZIJIANG PHARMA GROUP SHANGHAI HAINI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, this patent only discloses the use of an appropriate amount of ethanol to dissolve Edaravone, and does not control the amount of ethanol. Therefore, the preparation prepared by this patent method has certain potential safety hazards and is not suitable for clinical application.

Method used

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  • Preparation method of edaravone injection
  • Preparation method of edaravone injection
  • Preparation method of edaravone injection

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preparation example Construction

[0044] The preparation method of the embodiment of the present application at least includes the steps of liquid preparation, potting and sterilization, wherein the processes of liquid preparation and potting are all carried out under nitrogen protection. Since the edaravone raw material is easily oxidized, it is carried out under the protection of nitrogen gas throughout the preparation and filling process.

[0045] Further optionally, the nitrogen pressure is not less than 0.02Mpa during the concentrated preparation process, the nitrogen pressure is not less than 0.01Mpa and not greater than 0.02Mpa during the thin preparation process, and the nitrogen pressure is not less than 0.2Mpa during the potting process. In order to ensure the stability of the equipment, the maximum nitrogen pressure should not exceed 0.5Mpa. The present invention has found through research that differential control of the pressure of nitrogen filling in different processes can more effectively improve...

Embodiment 1

[0066] Edaravone injection was prepared according to the original research prescription of Edaravone injection in Table 1 above. The preparation method is:

[0067] 1. Concentrated

[0068] 1.1 Preparation of oxygen-expelling water for injection: put water for injection at 90°C to 100°C in a container, vacuumize while stirring, and then inject nitrogen gas at a pressure of 0.02Mpa.

[0069] Add oxygen-expelling water for injection at a temperature of 90°C to 100°C in the concentrated preparation tank, and the amount of added oxygen-expelling water for injection is 80% of the prescribed amount; Dissolved sodium chloride; predissolve the prescribed amount of cysteine ​​hydrochloride in a glass container with 60°C oxygen-expelling water for injection, and the concentration of the cysteine ​​hydrochloride solution is 30 mg / ml; then add the prescribed amount of Edala Bong was added to the cysteine ​​hydrochloride solution for wetting to obtain solution I.

[0070] 1.2 Add the so...

Embodiment 2

[0081] Edaravone injection was prepared according to the original research prescription of Edaravone injection in Table 1 above. The preparation method is:

[0082] 1. Concentrated

[0083] 1.1 Preparation of oxygen-expelling water for injection: put water for injection at 90°C to 100°C in a container, vacuumize while stirring, and then inject nitrogen gas at a pressure of 0.02Mpa.

[0084]Add oxygen-expelling water for injection at a temperature of 90°C to 100°C in the concentrated preparation tank, and the amount of added oxygen-expelling water for injection is 70% of the prescription amount; cool down the temperature of oxygen-expelling water for injection to 80°C, Dissolved sodium chloride; pre-dissolve the prescribed amount of cysteine ​​hydrochloride in a glass container with 80°C deoxygenation water for injection, and the concentration of the cysteine ​​hydrochloride solution is 32mg / ml; then add the prescribed amount of Edala Bong was added to the cysteine ​​hydrochl...

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Abstract

The invention relates to the field of medicines, in particular to a preparation method of an edaravone injection. The preparation method at least comprises the steps of liquid preparation, encapsulation and sterilization, wherein the processes of liquid preparation and encapsulation are carried out under the protection of nitrogen. In a preparation process, a cysteine hydrochloride solution is prepared firstly, and then edaravone is added into the cysteine hydrochloride solution. By improving the preparation method of the edaravone injection and accurately controlling conditions, the preparation method provided by the invention not only does not need to change an original research prescription of the edaravone injection, but also can further improve the stability of the edaravone injection.

Description

technical field [0001] The invention relates to the field of medicines, in particular to a preparation method of Edaravone injection. Background technique [0002] Ischemic cerebral stroke is cerebral infarction, which accounts for 70% to 80% of all strokes. symptoms of neurological deficits. In my country, stroke has become the leading cause of death among urban and rural residents nationwide and the second leading cause of death in the world. Stroke has the characteristics of high morbidity, disability, mortality and complications, which seriously endanger human health. Among the surviving patients, only about 10% can fully recover normal functions, and the vast majority of patients have sequelae such as hemiplegia and aphasia, causing serious burdens to society and families. [0003] Edaravone (Edaravone) chemical name: 3-methyl-1-phenyl-2-pyrazolin-5-one, the structural formula is as follows: [0004] [0005] Edaravone is a brain protectant (free radical scavenge...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/4152A61K47/18A61P9/10
CPCA61K9/0019A61K9/08A61K31/4152A61K47/183
Inventor 明从梅李玲玲郑璐姜锋朱华荣高苇
Owner YANGZIJIANG PHARMA GROUP SHANGHAI HAINI PHARMA
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