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Edaravone-containing injection

A technology for injection and water for injection, which is applied in the directions of medical preparations containing active ingredients, medical preparations without active ingredients, organic active ingredients, etc., and can solve the problems of increasing the cost of medicines, many preparation process steps, and pollution of medicinal liquids.

Inactive Publication Date: 2010-06-16
湖南万健康品生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, when Edaravone powder injection is used clinically, it needs to be injected with sodium chloride injection to dissolve it, which brings troubles and the possibility of errors to the medical staff, and it is easy to cause contamination of the liquid medicine during operation.
[0006] Chinese patent application CN101536979A discloses a kind of edaravone lipid microsphere preparation and preparation method thereof, it uses soybean lecithin and poloxamer 188 mixed emulsifier of specific ratio as emulsifier, uses soybean oil for injection as oil phase solvent, The edaravone lipid microsphere injection preparation, which contains conventional antioxidants in pharmaceuticals, has significantly improved stability, but there are many types of excipients and many steps in the preparation process, which indirectly increases the cost of the drug

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0122] prescription:

[0123] Edaravone 10g

[0124] 1,2-propanediol 50ml

[0125] Ethanol 100ml

[0126] Sodium metabisulfite 0.05g

[0127] Add water for injection to 1000ml

[0128] 1mol / L hydrochloric acid solution to adjust the pH to 5.0

[0129] Preparation Process:

[0130] (1) Add the 1,2-propanediol and ethanol of the prescribed amount to the full amount of 30% water for injection at 50-60°C respectively, stir and mix;

[0131] (2) Add 0.1-0.3% (w / v) activated carbon, heat and stir for 20 minutes, and filter to remove carbon;

[0132] (3) Add the prescribed amount of edaravone and sodium metabisulfite to the above solution, stir evenly, use water for injection to measure to the full amount, adjust the pH value to 5.0 with hydrochloric acid, and then filter with a 0.22 μm microporous membrane ;

[0133] (4) Potting and sealing in glass ampoules (filling 3ml of liquid in glass ampoules of 3ml volume), fusing and sealing;

[0134] (5) Sterilize at 116°C for 40 m...

Embodiment 2

[0136] prescription:

[0137] Edaravone 20g

[0138] 1,2-propanediol 120ml

[0139] Ethanol 100ml

[0140] Sodium metabisulfite 0.1g

[0141] Add water for injection to 1000ml

[0142] 1mol / L hydrochloric acid solution to adjust the pH to 4.5

[0143] The preparation process is the same as in Example 1, and the glass ampoule (5ml liquid is filled in a glass ampoule with a volume of 5ml) is used for sub-packaging.

Embodiment 3

[0145] prescription:

[0146] Edaravone 30g

[0147] 1,2-propanediol 180ml

[0148] Ethanol 60ml

[0149] Sodium metabisulfite 0.1g

[0150] Add water for injection to 1000ml

[0151] 1mol / L hydrochloric acid solution to adjust the pH to 4.8

[0152] Preparation process: the preparation process is the same as in Example 1.

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Abstract

The invention relates to an edaravone-containing injection, which belongs to the field of pharmaceutical preparation. The edaravone-containing high-concentration injection consists of 1 to 5 percent (w / v) of edaravone, 5 to 25 percent (v / v) of 1,2-propanediol, 5 to 15 percent (v / v) of ethanol and water for injection, and has a pH of 4.5 to 5.5. The edaravone-containing injection in clinical use is added to sodium chloride infusion solution for the intravenous drip of patients, increases the population of applicable patients, and is applicable to the patients with acute cerebral infarction.

Description

technical field [0001] The invention relates to a western medicine injection, in particular to a high-concentration injection of edaravone, and belongs to the field of pharmaceutical preparations. Background technique [0002] Edaravone is a brain protectant (free radical scavenger). Clinical studies suggest that N-acetylaspartic acid (NAA) is a specific marker of surviving nerve cells, and its content decreases sharply in the early stage of cerebral infarction. The administration of edaravone to patients in the acute stage of cerebral infarction can inhibit the reduction of local cerebral blood flow around the infarction, and make the NAA content in the brain significantly higher than that of the glycerol control group on the 28th day after the onset. Preclinical studies suggest that intravenous administration of edaravone to rats after ischemia / ischemia-reperfusion can prevent the progression of cerebral edema and cerebral infarction, relieve the accompanying neurological...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/4152A61K47/10A61K47/02A61P9/10
Inventor 邹立兴孟汇卓
Owner 湖南万健康品生物科技有限公司
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