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Edaravone injection without antioxidant and preparation method thereof

A technology for edaravone and injection, which is applied in the field of edaravone injection and its preparation, and can solve the problems of yellowing of the liquid, harm to human body, influence on product quality and the like

Active Publication Date: 2014-11-05
CHENGDU BAIYU PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Antioxidants such as cysteine ​​hydrochloride and sodium bisulfite are added to the products listed in Japan and many domestic products. The oxidants can effectively prevent the oxidation of Edaravone, but after being oxidized, certain impurities will be produced to affect the quality of the product. quality, and the oxidized cysteine ​​hydrochloride will make the liquid yellow, and sulfites are harmful to the human body

Method used

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  • Edaravone injection without antioxidant and preparation method thereof
  • Edaravone injection without antioxidant and preparation method thereof
  • Edaravone injection without antioxidant and preparation method thereof

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preparation example Construction

[0029] The steps of the preparation method of the injection of the present invention are: A, dosing; B, filtration; C, filling; D, sterilization; in the first 3 steps, nitrogen protection is uniformly filled, and the residual oxygen content in the injection is controlled≤2mg / L.

[0030] The method of the present invention has two kinds of modes when dosing liquid, and one of them adopts heating water for injection, so that dissolve Edaravone. The second is to add acid to adjust the pH value of the aqueous solution to be adjusted to between 1.0-2.0 so as to dissolve the edaravone.

Embodiment 1

[0031] Embodiment 1 adopts heating water for injection to dissolve Edaravone

[0032] prescription:

[0033] Edaravone 30g

[0034] Disodium hydrogen phosphate 10g

[0035] Add water for injection to 20L

[0036] Preparation:

[0037] A. Take 80% water for injection, heat to 80°C, fill with nitrogen, add edaravone, stir until completely dissolved;

[0038] B. Use disodium hydrogen phosphate to adjust the pH value of the solution to 3.0-4.5, and replenish water to the specified scale;

[0039] C. Add activated carbon, stir and absorb for 10 minutes, and filter through a microporous membrane until clarified;

[0040] D. According to 20ml / bottle, fill with nitrogen and sterilize at 121°C for 15 minutes.

[0041] Comparative Example 1 Japan's commercially available Edaravone injection product instructions are as follows: figure 1 . according to figure 1 The proposed prescription shown is as follows:

[0042]

[0043] Preparation:

[0044] A. Take water for injection ...

preparation example 1

[0109] prescription:

[0110]

[0111] Preparation Process:

[0112] Add 80% water for injection, fill with nitrogen, control the amount of residual oxygen ≤ 2mg / L, keep the water temperature at room temperature (about 25°C), take an appropriate amount of hydrochloric acid solution to adjust the pH value to about 1.5, add edaravone and stir until completely dissolved, and transfer To the water for injection after nitrogen filling, add disodium hydrogen phosphate to adjust the pH value to 3.5-4.5, replenish water to the specified value, add activated carbon, stir and absorb, filter with 0.22um, 0.45um microporous membrane until clear, and empty the bottle Nitrogen-filled, filled in glass ampoules at 20ml / bottle, filled with nitrogen and then melt-sealed, and sterilized at 121°C for 15 minutes to obtain the product.

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Abstract

The invention belongs to the field of medicine preparation, and particularly relates to edaravone injection without an antioxidant and a preparation method thereof. The invention aims at providing the edaravone injection which contains few impurities, is short in preparation time and is free of addition of the antioxidant. The edaravone injection comprises edaravone, a pH value conditioning agent and water for injection; and the preparation method comprises the steps of: A. preparing liquid; B filtering; C. filling; and D. sterilizing, wherein nitrogen is fed for protection in the previous three steps, and the remaining oxygen in the water and the impurity content of the product are strictly controlled so as to ensure the safety and effectiveness of the edaravone injection in clinical application.

Description

technical field [0001] The invention belongs to the field of pharmacy, and in particular relates to an edaravone injection without an antioxidant and a preparation method thereof. Background technique [0002] Cerebral infarction, also known as ischemic stroke, refers to softening and necrosis of local brain tissue due to blood circulation disturbance, ischemia, and hypoxia. Evidence-seeking medicine has proved that thrombolytic therapy is the most effective method in the treatment of acute cerebral infarction after the stroke unit. However, thrombolytic therapy has secondary bleeding, fatal reperfusion injury, brain tissue edema, and vascular reocclusion. It also needs to effectively select the indications, and there are many contraindications. The most important thing is the strict time window of treatment. Even in the United States, a developed country, only less than 3% of stroke patients receive thrombolytic therapy. Therefore, brain protection therapy is currently th...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/4152A61K47/04A61K47/12A61P25/00A61P9/10
Inventor 孙毅田阿娟秦观红
Owner CHENGDU BAIYU PHARMA CO LTD
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