Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

Bivalirudin freeze-dried injection and preparation thereof

A technology of freeze-dried powder injection and bivalirudin, which is applied in the field of medicine, can solve the problems of variability of active ingredients, obvious degradation of bivalirudin, high impurity content, etc., achieve good stability of the preparation, improve stability and clinical application The effect of stability, good resolubility and compatibility stability

Active Publication Date: 2008-08-20
MUDANJIANG YOUBO PHARMA CO LTD
View PDF0 Cites 15 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] ANGIOMAX, a product listed abroad TM It is a sterile freeze-dried powder injection, which uses sodium hydroxide to adjust the pH, and its active ingredients are easily denatured, and the product has the defects of obvious degradation of bivalirudin and high impurity content

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Bivalirudin freeze-dried injection and preparation thereof
  • Bivalirudin freeze-dried injection and preparation thereof
  • Bivalirudin freeze-dried injection and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] The following tests were all prepared according to 20 preparations (20 ml volume).

[0020] (1) Take 1.3641g of bivalirudin crude drug, dissolve it with a small amount of water for injection, add 0.2mol / L sodium hydroxide to adjust the pH to about 5.30, add water to 20ml, freeze-dry, and take a sample to determine the relevant properties of this product. substance and content.

[0021] (2) Take 1.3635 g of bivalirudin raw material, dissolve it with a small amount of water for injection, add 0.5 mol / L sodium hydroxide to adjust the pH to about 5.33, add water to 20 ml, freeze-dry, and take a sample to determine the relevant properties of this product. substance and content.

[0022] (3) Take 1.3644g of bivalirudin crude drug, dissolve it with a small amount of water for injection, add 0.2mol / L sodium carbonate to adjust the pH to about 5.32, add water to 20ml, freeze-dry, and take samples to determine the related substances of this product and content.

[0023] (4) Ta...

Embodiment 2

[0029] Take 60.0 g of bivalirudin and 30.0 g of mannitol, dissolve them in 500 ml of water for injection, adjust the pH to 4.5-6.5 with 0.5 mol / L sodium carbonate solution, dilute to 1000 ml, and stir evenly. Sterile filtration with 0.22μm membrane, subpackaging, semi-stoppering, freeze-drying, stoppering, and capping to obtain the product with a specification of 60mg. Freeze-drying curve such as figure 1 shown.

Embodiment 3

[0031] Take 60.0 g of bivalirudin and 30.0 g of dextran, dissolve them in 500 ml of water for injection, adjust the pH to 4.5-6.5 with 0.5 mol / L sodium carbonate solution, dilute to 1000 ml, and stir evenly. Sterile filtration with 0.22μm membrane, subpackaging, semi-stoppering, freeze-drying, stoppering, and capping to obtain the product with a specification of 60mg.

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

No PUM Login to View More

Abstract

The invention discloses bivalirudin bacteria-free lyophilized injection and the preparation method, which adopts sodium carbonate or sodium bicarbonate to adjust pH. The bivalirudin bacteria-free lyophilized injection and the preparation method has the advantages of overcoming the drawback of poor stability for bivalirudin preparation of prior art, significantly lowering degradation of active components for products, having low impurity content and good stability and improving use safety and effectiveness for clinical application of preparation.

Description

technical field [0001] The invention relates to a sterile freeze-dried powder injection of bivalirudin and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Bivalirudin is a synthetic peptide that is very soluble in water. Because synthetic polypeptide drugs have the characteristics of poor stability, easy to be degraded by proteolytic enzymes in the gastrointestinal tract, short biological half-life in the body, and difficult to pass through biological barriers, they are usually administered by injection. The main dosage forms are freeze-dried powder injection and injection. The results of the study showed that the drug was very unstable in the solution state. [0003] ANGIOMAX, a product listed abroad TM It is a sterile freeze-dried powder injection, which uses sodium hydroxide to adjust the pH, and its active ingredients are easily denatured, and the product has the defects of obvious degradation of bivalirudin and...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
IPC IPC(8): A61K9/19A61K38/10A61K47/02
Inventor 李振国
Owner MUDANJIANG YOUBO PHARMA CO LTD
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com