Edaravone injection and preparation process thereof

A technology of edaravone and preparation process, applied in the field of edaravone injection preparation and preparation process, can solve the problems of easy oxidation, poor stability and the like

Active Publication Date: 2011-01-05
NANJING SIMCERE DONGYUAN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The purpose of the present invention is to solve the problem of poor stability and easy oxidation of Edaravone in aqueous solution, by adding suitable antioxidants and cosolvents in the solution, adjusting pH, and gett

Method used

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  • Edaravone injection and preparation process thereof
  • Edaravone injection and preparation process thereof
  • Edaravone injection and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] Formula (specification: 5ml: 10mg)

[0055] Raw materials

Dosage

effect

Specification

Edaravone

10g

Main drug

Medicinal

Hydroxypropyl Beta Cyclodextrin

40g

Co-solvent

Medicinal

Bamboo leaf flavonoids

5g

antioxidant

Medicinal

Add water for injection to

5000ml

solvent

Injection

Potting nitrogen filling

Residual oxygen 1.8%

prevent oxidation

High purity nitrogen

[0056] Add the prescribed amount of Edaravone, hydroxypropyl beta cyclodextrin, and bamboo leaf flavonoids into water for injection, stir until completely dissolved, add activated carbon for needles, and oxidize with 0.1mol / L hydrochloric acid and / or hydrogen after removing the carbon Adjust the pH with sodium solution, fill it with nitrogen, seal it in an ampoule, and sterilize it by autoclaving at 115°C for 30 minutes.

[0057] The sample was inspected after 3 years, and the inspections...

Embodiment 2

[0059] Formula (specification: 5ml: 10mg)

[0060] Raw materials

Dosage

effect

Specification

Edaravone

10g

Main drug

Medicinal

Propylene Glycol

400g

Co-solvent

Medicinal

Bamboo leaf flavonoids

4g

antioxidant

Medicinal

[0061] Add water for injection to

5000ml

solvent

Injection

Potting nitrogen filling

Residual oxygen 1.6%

prevent oxidation

High purity nitrogen

[0062] Dissolve the edaravone in the prescribed amount in propylene glycol, stir until it is completely dissolved, add an aqueous solution of vitamin C and stir, add activated carbon for needles, and adjust the pH with 0.1mol / L hydrochloric acid and / or sodium hydroxide solution after carbon removal, Fill it with nitrogen, seal it in an ampoule, and sterilize it by autoclaving at 115°C for 30 minutes.

[0063] The sample was inspected after 3 years, and the inspections of shape, pH, v...

Embodiment 3

[0065] Formula (Specification: 20ml: 30mg)

[0066] Raw materials

Dosage

effect

Specification

Edaravone

30g

Main drug

Medicinal

Hydroxypropyl Beta Cyclodextrin

160g

Co-solvent

Medicinal

Bamboo leaf flavonoids

24g

antioxidant

Medicinal

Add water for injection to

20000ml

solvent

Injection

Potting nitrogen filling

Residual oxygen 1.5%

prevent oxidation

High purity nitrogen

[0067] Add the prescribed amount of Edaravone, hydroxypropyl beta cyclodextrin, and bamboo leaf flavonoids into water for injection, stir until completely dissolved, add activated carbon for needles, and oxidize with 0.1mol / L hydrochloric acid and / or hydrogen after removing the carbon Adjust the pH with sodium solution, fill it with nitrogen, seal it in an ampoule, and sterilize it by autoclaving at 115°C for 30 minutes.

[0068] The sample was inspected after 3 years, and the inspect...

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PUM

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Abstract

The invention discloses edaravone injection and a preparation process thereof. The injection contains an active component edaravone and an antioxidant bamboo flavonoid. The stability of the edaravone injection is improved, the valid period of the injection is prolonged, and the edaravone injection is safe and effective clinically.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a stable Edaravone injection preparation and a preparation process. Background technique [0002] Edaravone Injection (Edaravone Injection) is a cranial neuroprotective agent developed by Mitsubishi Tokyo Pharmaceutical Co., Ltd. for the treatment of patients with acute cerebral infarction. Nanjing Xiansheng Dongyuan Pharmaceutical Co., Ltd. was the first to develop and market in my country in December 2003. The product name is Bicun The drug is a new type of free radical scavenger and neuroprotective drug for the treatment of ischemic cerebrovascular diseases, and has clear clinical efficacy in the treatment of cardiovascular and cerebrovascular diseases, especially acute ischemic stroke. [0003] Edaravone is a powerful free radical scavenger. After cerebral ischemia and hypoxia, it can inhibit the production of a large number of free radicals ...

Claims

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Application Information

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IPC IPC(8): A61K36/899A61K9/08A61P9/10A61P25/00A61P39/06A61K31/4152
Inventor 彭素琴罗兴洪周进东葛宗明赵茜周静
Owner NANJING SIMCERE DONGYUAN PHARM CO LTD
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