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Edaravone-containing injection

A technology for injection and water for injection, which is applied to medical preparations containing active ingredients, medical preparations with non-active ingredients, organic active ingredients, etc. It can solve problems such as errors, contamination of medicinal liquid, and many steps in the preparation process.

Inactive Publication Date: 2012-04-25
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

specific Embodiment 1

[0047] To specific embodiment 1,2,3,4,5,6 prepared Edaravone injection sample (remove outer packaging) and reference substance (the Edaravone injection that has been listed: trade name " must deposit ", Produced by Nanjing Xiansheng Dongyuan Pharmaceutical Co., Ltd., batch number 20080920) were subjected to high temperature (60°C ± 2°C) influence factor test for 10 days and high temperature light (4500Lx ± 500Lx) influence factor test for 10 days. On the 5th day and the 10th day, samples were taken for testing. The results of the high temperature test are shown in Table 1, and the results of the light test are shown in Table 2.

[0048] Table 1 High temperature test results

[0049] place a study project

[0050] Time Sample Appearance color pH Visible foreign matter Content Related substances

Embodiment 1

[0051] Example 1 Colorless and clear 5.0 Complies with regulations 100.1 0.08

Embodiment 2

[0052] Example 2 Colorless and clear 4.5 Complies with regulations 100.2 0.05

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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 Patents(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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