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Doxofylline-contained liquid injection, preparation method and quality control method thereof

A technology of doxofylline and water injection, applied in the field of water injection containing doxofylline, achieving the effect of flexible specification design

Active Publication Date: 2009-11-04
HEILONGJIANG FUHE HUAXING PHARMA GROUP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there is no control of related substances in this standard, therefore, the quality standard of doxofylline injection also has deficiencies, and the improvement of the quality control standard for doxofylline injection is also expected in the prior art

Method used

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  • Doxofylline-contained liquid injection, preparation method and quality control method thereof
  • Doxofylline-contained liquid injection, preparation method and quality control method thereof
  • Doxofylline-contained liquid injection, preparation method and quality control method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0089] Specification: 10ml:0.2g

[0090] Take 4000ml of water for injection, heat up, add 200g of doxofylline under stirring, wait until the temperature of the liquid rises to about 80°C, add 20g of activated carbon after the powder is completely dissolved, continue stirring for 10 minutes, wait until the temperature drops to 40°C, filter to remove carbon , have a thick dosing solution. Take the concentrated solution and add water for injection to make up to 10000ml, stir evenly, filter through a microporous membrane until the clarity is qualified, then take a sample to check the content and pH value. The content should be 95-105% of the labeled amount, and the pH value should be 5.0-6.5. Put it in a 10ml ampoule in a clean area, seal it, place it in an autoclave, steam sterilize it at 115°C for 30 minutes, and get it after finished product inspection, printing, and packaging.

Embodiment 2

[0092] Specifications: 20ml:0.3g

[0093] Take 6000ml of water for injection, heat up, add 300g of doxofylline under stirring, wait until the temperature of the liquid rises to about 80°C, add 30g of activated carbon after the medicine powder is completely dissolved, continue stirring for 10 minutes, wait until the temperature drops to 40°C, filter to remove carbon , have a thick dosing solution. Take the concentrated solution and add water for injection to make up to 20000ml, stir evenly, filter through a microporous membrane until the clarity is qualified, then take a sample to check the content and pH value. The content should be 95-105% of the labeled amount, and the pH value should be 5.0-6.5. Put it in a 10ml ampoule in a clean area, seal it, place it in an autoclave, steam sterilize it at 115°C for 30 minutes, and get it after finished product inspection, printing, and packaging.

Embodiment 3

[0095] Specifications: 20ml:0.2g

[0096] Take 6000ml of water for injection, heat up, add 200g of doxofylline under stirring, wait until the temperature of the liquid rises to about 80°C, add 30g of activated carbon after the powder is completely dissolved, continue stirring for 10 minutes, wait until the temperature drops to 40°C, filter to remove carbon , have a thick dosing solution. Take the concentrated solution and add water for injection to make up to 20000ml, stir evenly, filter through a microporous membrane until the clarity is qualified, then take a sample to check the content and pH value. The content should be 95-105% of the labeled amount, and the pH value should be 5.0-6.5. Put it in a 10ml ampoule in a clean area, seal it, place it in an autoclave, steam sterilize it at 115°C for 30 minutes, and get it after finished product inspection, printing, and packaging.

[0097] Trial-produce pilot products according to the above process, the theoretical quantity of ...

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Abstract

The invention relates to a doxofylline-containing liquid injection used for treating bronchiectasis, and provides the doxofylline with higher concentration. The injection comprises doxofylline, a water solvent, and a pH value regulating agent. The injection comprises the following components by weight percentage: 1 to 4 percent of the doxofylline, and 0.01 to 5 percent of the pH value regulating agent. The injection enriches specifications of the prior doxofylline injection, and brings convenience to the clinical application. The invention also provides a preparation method and a quality control method for the doxofylline liquid injection. Relevant materials in the doxofylline injection can be determined by an HPLC method to improve the product controllability.

Description

technical field [0001] The invention relates to a water injection containing doxofylline for treating bronchiectasis, a preparation method and a quality control method of the water injection. Background technique [0002] Doxofylline, a derivative of methylxanthine, is a bronchodilator that acts directly on the bronchi to relax bronchial smooth muscle. By inhibiting the action of phosphodiesterase in smooth muscle cells, it relaxes smooth muscle, thereby achieving the effect of inhibiting asthma. [0003] Doxofylline was first listed in 1980 by the Italian ABC company. The marketed dosage forms of doxofylline include syrup, tablet, aqueous injection, infusion and so on. Doxofylline Injection (10ml:0.1g) was the first approved by Heilongjiang Fuhe Huaxing Pharmaceutical Group Co., Ltd. in 2000 to be marketed in China. Since the original specification of this product is 10ml:0.1g, this product is clinically used When doing intravenous injection, each dosage is 0.2g (equival...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/52A61P11/08G01N30/02
Inventor 吴光彦吴玉山于海燕王洪福王景坤
Owner HEILONGJIANG FUHE HUAXING PHARMA GROUP
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