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Edaravone medicinal composition for injection and preparation method thereof

A composition and injection technology, applied in the field of medicine, can solve the problems of difficult dissolution of edaravone and poor stability of the pharmaceutical composition, and achieve the effects of simple and easy production method, stable product quality and optimized prescription quantity

Inactive Publication Date: 2012-02-01
TIANJIN SONGRUI MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0021] The object of the present invention is to provide a kind of edaravone pharmaceutical composition for injection and preparation method thereof, it can overcome the deficiencies in the prior art, effectively solve the difficult problem of edaravone dissolving, by adding special antioxidant, effectively The problem of poor stability of the pharmaceutical composition is solved

Method used

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  • Edaravone medicinal composition for injection and preparation method thereof
  • Edaravone medicinal composition for injection and preparation method thereof
  • Edaravone medicinal composition for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0129] Edaravone injection prepared 1000, wherein:

[0130]

[0131] Preparation Process:

[0132] 1) Preparation: Edaravone is prepared into an amorphous form by spray drying and set aside;

[0133] 2) Take 70% of the prescribed amount of water for injection, at a temperature of 50-70°C, add the prescribed amount of thiobisethyl alcohol, disodium hydrogen phosphate, and sodium chloride, stir until dissolved, and then add the prescribed amount of ida into the solution Lavone, stir until completely dissolved;

[0134] 3) Add 0.05-0.1% medicinal charcoal in the volume of the liquid medicine to item 2), stir well, and place it for 15-30 minutes;

[0135] 4) Filter 3) with a plate and frame filter, add water for injection to the full amount, mix well, measure the initial pH value, adjust the pH value range to 3.0 with 4% sodium hydroxide solution and 10% phosphoric acid solution according to the initial pH value -4.5;

[0136] 5) Central control: conduct intermediate produc...

Embodiment 2

[0143] Edaravone injection prepared 1000, wherein:

[0144]

[0145]

[0146] Preparation process: with embodiment 1.

Embodiment 3

[0148] Edaravone injection prepared 1000, wherein:

[0149]

[0150] Preparation process: with embodiment 1.

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Abstract

The invention provides an edaravone medicinal composition for injection and a preparation method thereof. The medicinal composition consists of amorphous edaravone, sodium chloride and dihydroxyethyl sulfide, wherein 1000 pieces of the medicinal composition are prepared from 10 to 30g of the amorphous edaravone, 50 to 200g of sodium chloride, 1 to 3g of dihydroxyethyl sulfide, 2 to 6g of disodiumhydrogen phosphate, a proper amount of pH regulating agent and 10 to 20L of injection water by virtue of sterilization. The preparation method of the medicinal composition comprises the following steps: preparing the edaravone into an amorphous state for later use; adding the injection water according to the amount of prescription into raw and auxiliary materials according to the amounts of the prescription until the raw and auxiliary materials are dissolved completely; and decarburizing, filtering, supplying the injection water to a full dose, uniformly mixing, regulating the pH value, performing fine filtering, filling, sterilizing, testing by use of a lamp, packaging and sending into a warehouse. The edaravone medicinal composition has simple prescription and excellent stability, and is suitable for long-term storage and industrial large-scale production.

Description

technical field [0001] The invention relates to the field of medicine, in particular to an edaravone pharmaceutical composition for injection and a preparation method thereof. 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 Bi , 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. Edaravone injection is the first free radical scavenger used to treat acute cerebral infarction. It is the metabolite of antipyretic and analgesic drug antipyrine in the body. In t...

Claims

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Application Information

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IPC IPC(8): A61K31/4152A61K47/20A61P9/10A61K9/08
Inventor 张昊
Owner TIANJIN SONGRUI MEDICAL TECH
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