Solution preparation for terbutaline sulphate aerosol inhalation and preparation method of solution preparation

A technology of terbutaline sulfate and atomization inhalation, applied in aerosol delivery, medical preparations containing active ingredients, pharmaceutical formulations, etc., can solve problems such as bone calcium loss, toxic side effects, etc. The effect of medication safety and product quality

Inactive Publication Date: 2020-01-17
BEIJING INCREASE INNOVATIVE DRUG RESEARCH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Chinese patent CN106667974A discloses an atomized inhalation preparation of terbutaline sulfate, which contains components including terbutaline sulfate, stabilizer, isotonic agent, pH regulator and water for injection, but stabilizer is added to the product There is a risk of toxic and side effects, especially the currently used stabilizer sodium ethylenediaminetetraacetate. Excessive intake can lead to hypocalcemia or loss of bone calcium. Therefore, the content of the stabilizer in the product should be used under the premise of ensuring effective anti-oxidation should be reduced as much as possible

Method used

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  • Solution preparation for terbutaline sulphate aerosol inhalation and preparation method of solution preparation
  • Solution preparation for terbutaline sulphate aerosol inhalation and preparation method of solution preparation
  • Solution preparation for terbutaline sulphate aerosol inhalation and preparation method of solution preparation

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Experimental program
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Effect test

Embodiment 1

[0055] prescription:

[0056]

[0057] Process:

[0058] Take 70% water for injection (700ml) into a suitable container, fill it with nitrogen until dissolved oxygen <1mg / L (continue until the end of sample preparation), add terbutaline sulfate and sodium chloride and stir to dissolve, adjust the pH of the solution to 3.5 with hydrochloric acid , with water for injection to constant volume, with 0.45 μm filter membrane for primary filtration, 0.22 μm filter membrane for fine filtration, all sterile filtered, subpackaged in ampoules, filled with nitrogen gas protection, and melt sealed.

Embodiment 2

[0060] prescription:

[0061]

[0062] Process:

[0063] Take 70% water for injection (700ml) into a suitable container, fill it with nitrogen until dissolved oxygen <1mg / L (continue until the end of sample preparation), add terbutaline sulfate and sodium chloride and stir to dissolve, adjust the pH of the solution to 4.0 with hydrochloric acid , with water for injection to constant volume, with 0.45 μm filter membrane for primary filtration, 0.22 μm filter membrane for fine filtration, all sterile filtered, subpackaged in ampoules, filled with nitrogen gas protection, and melt sealed.

Embodiment 3

[0065] prescription:

[0066]

[0067] Process:

[0068] Take 70% water for injection (700ml) into an appropriate container, fill it with nitrogen until dissolved oxygen <1mg / L (continue until the end of sample preparation), add terbutaline sulfate and sodium chloride and stir to dissolve, adjust the pH of the solution to 4.0 with sulfuric acid , with water for injection to constant volume, with 0.45 μm filter membrane for primary filtration, 0.22 μm filter membrane for fine filtration, all sterile filtered, subpackaged in ampoules, filled with nitrogen gas protection, and melt sealed.

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PUM

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Abstract

The invention provides a solution preparation for terbutaline sulphate aerosol inhalation and a preparation method of the solution preparation. The solution preparation for terbutaline sulphate aerosol inhalation comprises terbutaline sulphate and / or a hydrate thereof, an osmotic pressure regulator, a pH regulator and a solvent. The solution preparation for terbutaline sulphate aerosol inhalationdisclosed by the invention has the characteristics of being efficient, low in toxicity, good in stability and high in safety degree.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a solution preparation for terbutaline sulfate atomized inhalation and a preparation method thereof. Background technique [0002] With the continuous improvement of people's living standards, people's awareness of health care has gradually increased, and they have begun to pay more attention to the occurrence of some diseases; however, with the improvement of people's living standards, under the influence of air pollution and environmental deterioration on a global scale, many People still cannot avoid the attack of asthma. In recent years, the morbidity and mortality of asthma have shown a growing trend, and it has become a major chronic disease threatening public health. Asthma not only seriously endangers people's physical and mental health, weakens labor ability, reduces quality of life, but also is difficult to cure. It is prone to recurrent attacks ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/72A61K31/137A61K9/08A61P11/06A61P11/00
CPCA61K31/137A61K9/0073A61K9/08A61P11/06A61P11/00
Inventor 张保献胡杰丁冬陈冬真
Owner BEIJING INCREASE INNOVATIVE DRUG RESEARCH CO LTD
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