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Method for effectively reducing impurity content in oral solution for treating bronchial asthma

A technology for bronchial asthma and oral solution, applied in the field of medicine to achieve the effect of improving product safety

Pending Publication Date: 2022-05-27
辽宁大熊制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The technical effect of this patented technology is that it can reduce harmful substances like nitrogen oxide (NOx) from drinks containing amoxic acid without affect their quality significantly during production processes. This results in improved products' security against contamination caused by these compounds while maintaining good taste characteristics over time.

Problems solved by technology

This patented technical issue addressed in this patents relates to finding ways to prevent unwanted substances from being introduced into pharmaceuticals due to their potential negative effects upon humans who use them over longer periods of time.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] A method for effectively reducing the content of impurities in a certain oral solution for the treatment of bronchial asthma, characterized in that: filling the ketotifen fumarate solution after dilution to a constant volume into a brown glass bottle, and placing the ketotifen fumarate solution in a brown glass bottle. Fill argon above the liquid level of the brown glass bottle, and the residual oxygen above the liquid level of the ketotifen fumarate solution in the brown glass bottle is 5%;

[0016] When the residual oxygen amount above the liquid level of the ketotifen fumarate solution was 5%, the impurity G content after 6 months of acceleration was 0.55%.

Embodiment 2

[0018] A method for effectively reducing the content of impurities in a certain oral solution for the treatment of bronchial asthma, characterized in that: filling the ketotifen fumarate solution after dilution to a constant volume into a brown glass bottle, and placing the ketotifen fumarate solution in a brown glass bottle. Argon gas is filled above the liquid level of the brown glass bottle, and the residual oxygen above the liquid level of the ketotifen fumarate solution in the brown glass bottle is 10%;

[0019] When the residual oxygen amount above the liquid level of the ketotifen fumarate solution was 10%, the impurity G content was 0.82% after 6 months of acceleration.

Embodiment 3

[0021] A method for effectively reducing the content of impurities in a certain oral solution for the treatment of bronchial asthma, characterized in that: filling the ketotifen fumarate solution after dilution to a constant volume into a brown glass bottle, and placing the ketotifen fumarate solution in a brown glass bottle. Fill argon above the liquid level of the brown glass bottle, and the residual oxygen above the liquid level of the ketotifen fumarate solution in the brown glass bottle is 15%;

[0022] When the residual oxygen amount above the liquid level of the ketotifen fumarate solution was 15%, the impurity G content was 0.94% after 6 months of acceleration.

[0023] From this, it can be known that the limit of impurity G is: not more than 1.0%. The experimental results show that when the residual oxygen content is 5%-15%, the content of impurity G after 6 months of acceleration is less than the limit of 1.0%.

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Abstract

The invention relates to a method for effectively reducing the content of impurities in an oral solution for treating bronchial asthma, which is characterized by comprising the following steps of: filling a brown glass bottle with a diluted and constant-volume ketotifen fumarate solution, and filling argon above the liquid level of the ketotifen fumarate solution, the residual oxygen content above the liquid level of the ketotifen fumarate solution in the brown glass bottle is 5%-15%. According to the method for effectively reducing the content of the impurities in the oral solution for treating bronchial asthma, the content of the impurity G in the oral solution is controlled by filling the liquid level of the ketotifen fumarate oral solution with the protective gas until the residual oxygen amount is below a certain limit, the product safety is improved, and the content of the impurity G meets the requirement in the long-term/accelerated placement process.

Description

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Claims

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Application Information

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Owner 辽宁大熊制药有限公司
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