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Process treatment method for improving stability of terbutaline sulphate solution for nebulization

A technology of terbutaline sulfate and treatment method, which is applied in the field of medicine, can solve the problems of high production operation requirements and high production costs, and achieve the effects of low requirements, ensuring stability and saving production costs

Active Publication Date: 2021-01-29
南京华盖制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] At present, nitrogen filling is mainly used in the process to ensure the stability of the product. Nitrogen filling has high requirements for the production line, high production operation requirements, and high production costs. In order to solve the above problems, the present invention provides a non- An aseptic production process that requires nitrogen filling and can ensure the stability of terbutaline sulfate atomized liquid

Method used

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  • Process treatment method for improving stability of terbutaline sulphate solution for nebulization
  • Process treatment method for improving stability of terbutaline sulphate solution for nebulization
  • Process treatment method for improving stability of terbutaline sulphate solution for nebulization

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Effect test

Embodiment 1

[0044] prescription:

[0045]

[0046] A process for improving the stability of terbutaline sulfate atomized liquid is as follows:

[0047] 1. Clean the equipment until the pH of the cleaning water is 6.0-8.0

[0048] 2. Weigh edetate disodium, add water for injection at 25°C to prepare 0.02% edetate disodium solution, use this solution to passivate the production equipment on the production line, passivation time 1h, passivation temperature 25°C .

[0049] 3. Take 30% of the prescribed amount of water for injection and add it to the passivated liquid mixing tank at 40°C, put in edetate disodium and stir to dissolve, then put in terbutaline sulfate and sodium chloride, and add water for injection to the batch size 80%, after stirring and dissolving, add 0.1mol / L hydrochloric acid solution to adjust the pH to 3.0-4.5, and add water for injection to the full batch.

[0050] 4. The liquid medicine is filtered through a 0.45μm filter and a 0.22μm bacteria-reducing filter.

...

Embodiment 2

[0053] prescription:

[0054]

[0055] A process for improving the stability of terbutaline sulfate atomized liquid is as follows:

[0056]1. Weigh edetate disodium, add 70°C for injection to prepare 0.04% edetate disodium solution, use this solution to passivate the production equipment on the production line, the passivation time is 2h, and the passivation temperature is 70°C . After passivation, clean the equipment until the pH of the cleaning water is 6.0-8.0.

[0057] 2. Take 30% of the prescribed amount of water for injection and add it to the passivated liquid mixing tank at 40°C, put in edetate disodium and stir to dissolve, then put in terbutaline sulfate and sodium chloride, and add water for injection to the batch size 80%, after stirring and dissolving, add 0.1mol / L hydrochloric acid solution to adjust the pH to 3.0-4.5, and add water for injection to the full batch.

[0058] 3. The liquid medicine is filtered through a 0.45μm filter and a 0.22μm bacteria-red...

Embodiment 3

[0061] prescription:

[0062]

[0063] A process for improving the stability of terbutaline sulfate atomized liquid is as follows:

[0064] 1. Wash the production equipment with 4% sodium hydroxide solution for 1 hour, and wash with water for injection until the pH of the cleaning water is 6.0-8.0; then wash the equipment with 11% citric acid solution for 2 hours, and wash with water for injection until the pH of the cleaning water is 6.0-8.0.

[0065] 2. Weigh edetate disodium, add 70°C for injection to prepare 0.02% edetate disodium solution, use this solution to passivate the production equipment on the production line, passivation time 1h, passivation temperature 70°C . After passivation, clean the equipment until the pH of the cleaning water is 6.0-8.0.

[0066] 3. Take 30% of the prescribed amount of water for injection and add it to the passivated liquid mixing tank at 40°C, put in edetate disodium and stir to dissolve, then put in terbutaline sulfate and sodium ch...

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Abstract

The invention belongs to the technical field of medicine, and particularly relates to a process treatment method for improving the stability of a terbutaline sulphate solution for nebulization. According to the invention, a metal chelating agent is adopted to passivate production equipment of a production line of the terbutaline sulphate solution for nebulization, and the passivated production equipment is employed to prepare liquid medicine. According to the process treatment method, metal ions on the surface of the production equipment are effectively removed through passivation of the equipment of the production line, and the stability of a product is guaranteed; and meanwhile, through an optimized packaging material, it is synchronously guaranteed that a final packaging material does not affect the product, nitrogen charging protection is not needed in the production process, a requirement on a production line is low, and production cost is saved.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a process treatment method for improving the stability of terbutaline sulfate atomized liquid and terbutaline sulfate atomized liquid obtained by adopting the treatment method. Background technique [0002] Terbutaline Sulfate Aerosol, developed by AstraZeneca and launched in Sweden in 1981, is a β2 adrenoceptor agonist that selectively excites β2 receptors to dilate the bronchi, which can increase the Pulmonary disease reduces the mucociliary cleaning function, thereby accelerating the clearance of mucus secretions. It not only has the effects of relieving asthma and eliminating phlegm, but also has the effect of relaxing bronchi. Clinically, it is mainly used to relieve bronchospasm associated with bronchial asthma, chronic bronchitis, emphysema and other lung diseases. Mainly administered through atomization, it has the advantages of fast onset of action, good a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/12A61K9/08A61K47/18A61K47/02A61K31/137A61P11/00A61P11/06
CPCA61K9/0078A61K9/08A61K31/137A61K47/02A61K47/183A61P11/00A61P11/06
Inventor 周鑫韩云张明月孙向阳
Owner 南京华盖制药有限公司
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