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Edaravone sodium chloride injection and preparation technology

A technology of edaravone sodium chloride and preparation technology, applied in the field of injection and preparation technology, can solve problems such as loss of drug efficacy, increase in filtration cost, etc., and achieves reduction of total amount of bacteria, reduced time, good sterilization and sterilization effect of effect

Inactive Publication Date: 2019-11-22
SICHUAN TAIPINGYANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Therefore, in the existing production method of Edaravone Sodium Chloride Injection, it is desired to better control the number of bacteria, but also to worry about the loss of drug efficacy and increase the cost of filtration, which is a problem that is difficult to solve.

Method used

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  • Edaravone sodium chloride injection and preparation technology
  • Edaravone sodium chloride injection and preparation technology

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] Prepare the Edaravone Sodium Chloride Injection of 100ml infusion bag. A total of 16000 bags of liquid medicine were prepared.

[0061] The ratio is as follows:

[0062]

[0063]

Embodiment 2

[0065] 1. Add about 80% of the prescribed amount of water for injection into the liquid preparation tank, set the water temperature to 46°C, fill with nitrogen for 25 minutes, monitor the dissolved oxygen and residual oxygen, so that the dissolved oxygen is less than 2mg / L, and the residual oxygen is less than 3%.

[0066] 2. Add the prescribed amount of cysteine ​​hydrochloride, sodium chloride, and sodium bisulfite in turn, and stir for 10 minutes to dissolve completely.

[0067] 3. Then add 0.01% medicinal activated carbon moistened with water for injection, and keep stirring at 46°C for 15 minutes.

[0068] 4. Pass the solution in the concentrated preparation tank through a titanium rod filter for decarbonization and filtration for 60 minutes, remove the titanium rod filter, connect the pipeline, pre-dissolve the prescribed amount of Edaravone with water for injection, and then add it to the liquid preparation tank , The water temperature in the liquid mixing tank is 46°C,...

Embodiment 3

[0080] 1. Add about 80% of the prescribed amount of water for injection into the liquid preparation tank, set the water temperature to 50°C, fill with nitrogen for 30 minutes, monitor the dissolved oxygen and residual oxygen, so that the dissolved oxygen is less than 2mg / L, and the residual oxygen is less than 3%.

[0081] 2. Add the prescribed amount of cysteine ​​hydrochloride, sodium chloride, and sodium bisulfite in turn, and stir for 10 minutes to dissolve completely.

[0082] 3. Then add medicinal activated carbon with a water content of 8% and a concentrated volume of 0.01% moistened with water for injection, and keep stirring at 50°C for 15 minutes.

[0083] 4. Pass the solution in the concentrated preparation tank through a titanium rod filter for decarbonization and filtration for 60 minutes, remove the titanium rod filter, connect the pipeline, pre-dissolve the prescribed amount of Edaravone with water for injection, and then add it to the liquid preparation tank , ...

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Abstract

The invention provides an edaravone sodium chloride injection and a preparation technology. According to matching, edaravone, sodium bisulfite, cysteine hydrochloride, sodium chloride, sodium hydroxide and phosphoric acid are added to water for injection. The preparation technology comprises the steps that the cysteine hydrochloride, sodium chloride and sodium bisulfite are added into the water for injection, and the mixture is stirred and completely dissolved; medicinal carbon is added for heat preservation and stirring, the solution in a mixing tank is decarburized and filtered, the edaravone with a prescription amount is pre-dissolved with the water for injection, the mixed solution is added into the mixing tank, the water for injection is supplemented to the total amount, the pH is adjusted, the whole solution is conveyed into a dilution tank, and bagging and filling are conducted. The invention provides novel matching components of the edaravone sodium chloride injection. The invention provides the new production preparation technology of the edaravone sodium chloride injection. The production preparation technology has a better bacterium-killing sterilization effect.

Description

technical field [0001] The invention relates to an injection and a preparation process. It belongs to the field of injection medicine production. Background technique [0002] Edaravone Sodium Chloride Injection is used to improve neurological symptoms, activities of daily living and dysfunction caused by acute cerebral infarction. The human preparation ratio of Edaravone and Sodium Chloride Injection has never been better, so that the existing Edaravone and Sodium Chloride Injection has low drug efficacy, and the therapeutic effect needs to be further improved. [0003] In the production process of Edaravone Sodium Chloride Injection, aseptic production has always been the key to the production of injections. During the production of injections, multiple sterilizations should be carried out to control the total number of bacteria within the qualified number. . [0004] The same is true in the production process of Edaravone Sodium Chloride Injection, the total number of ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/02A61K47/18A61K31/4152A61P9/10A61P25/00
CPCA61K9/0019A61K9/08A61K31/4152A61K47/02A61K47/183A61P9/10A61P25/00
Inventor 张加宇许艳春文娟王利华
Owner SICHUAN TAIPINGYANG PHARMA
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