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Preparation methods of ibuprofen arginine powder injection for injection

A technology for arginine and injection, which is applied in the field of preparation of arginine ibuprofen powder injection, can solve the problems of complex ibuprofen preparation method, high cost, and difficult quality control, and achieve easy quality control and low cost Low, high product yield effect

Inactive Publication Date: 2012-06-13
哈药集团中药二厂
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The present invention aims to solve the problems that the existing ibuprofen preparation method is complex, high in cost and difficult in quality control, and provides a preparation method of arginine ibuprofen powder for injection

Method used

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  • Preparation methods of ibuprofen arginine powder injection for injection
  • Preparation methods of ibuprofen arginine powder injection for injection
  • Preparation methods of ibuprofen arginine powder injection for injection

Examples

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specific Embodiment approach 1

[0010] Specific embodiment 1: The preparation method of arginine ibuprofen powder injection for injection of this embodiment is carried out according to the following steps: 1. Dissolve: mix ibuprofen and arginine at a molar ratio of 1:0.8 to 1.2, and then Add it to purified water at 20~50℃ and stir until it is completely dissolved to obtain the solution; 2. Ultrafiltration: The solution is subjected to ultrafiltration in a sterile environment, and then sterile packaging is carried out to divide the packaged solution; 3. Freezing Drying: freeze-dry the aliquoted solution for 40 to 45 hours to obtain a white freeze-dried powder, which is the arginine ibuprofen powder injection; the mass ratio of purified water to ibuprofen in step 1 is 10: 1.

specific Embodiment approach 2

[0011] Specific embodiment two: this embodiment is different from specific embodiment one in that in step one, ibuprofen and arginine are mixed at a molar ratio of 1:1. Others are the same as the first embodiment.

specific Embodiment approach 3

[0012] Specific embodiment three: This embodiment is different from specific embodiment one or two in that in step one, it is added to purified water at 30-40° C. and stirred until completely dissolved. Others are the same as the first or second embodiment.

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Abstract

The invention relates to preparation methods of ibuprofen arginine powder injection for injection, relating to preparation methods of ibuprofen arginine powder injection, which are used for solving the problems of being complex, high in cost and high in quality control difficulty in the traditional ibuprofen preparation method. The first method comprises the following steps of: mixing ibuprofen and arginine, and adding the mixture into purified water to be stirred till the mixture is completely dissolved so as to obtain a solution; carrying out ultra-filtration of the solution under a sterile environment, and split charging in a sterile manner; and freezing and drying to obtain white frozen powder, namely the ibuprofen arginine powder injection for injection. The second method comprises the following steps of: after dissolving the arginine into the purified water, adding the ibuprofen to obtain a solution; carrying out ultra-filtration of the solution under a sterile environment, and split charging in a sterile manner; and freezing and drying to obtain white frozen powder, namely the ibuprofen arginine powder injection for injection. Recovery, separation and crystallization of a solvent are not required. The methods disclosed by the invention are simple in process, low in cost, free from solvent residual, high in product yield and easy for quality control, wherein the product yield can be up to 93.1-95.8%.

Description

Technical field [0001] The invention relates to a preparation method of arginine ibuprofen powder injection. Background technique [0002] Ibuprofen is a non-steroidal anti-inflammatory and analgesic of phenylpropionic acid, which has strong antipyretic, analgesic, anti-inflammatory and anti-rheumatic effects. Its curative effect is similar to that of aspirin and phenylbutazone, it is better than acetaminophen, gastrointestinal side effects are lighter, and it is well tolerated. It is currently a widely used antipyretic and analgesic. However, because ibuprofen is insoluble in water, spicy taste, gastrointestinal irritation and other reasons, patients have poor compliance during use and cause unnecessary troubles during medication. [0003] In order to increase the water solubility of ibuprofen, the existing preparation method of ibuprofen uses organic solvents such as ethanol and acetone to dissolve it. The disadvantage of this method is that the solvent is difficult to recycle, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/205A61K31/192A61P29/00
Inventor 刘景国李文军郑玥杨满辉裴福成单钰毓广鸿雁肇静静
Owner 哈药集团中药二厂
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