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
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  • 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, ...

Method used

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  • 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.

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PUM

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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

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Application Information

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IPC IPC(8): A61K9/19A61K38/10A61K47/02
Inventor 李振国
Owner MUDANJIANG YOUBO PHARMA CO LTD
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