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Pharmaceutical composition for treating respiratory system diseases and preparation method thereof

A technique for respiratory diseases and compositions, which is applied in the field of pharmaceutical compositions for treating respiratory diseases and its preparation, and can solve the problems of poor stability of terbutaline sulfate, poor stability of ipratropium bromide, and poor stability of terbutaline sulfate. Stability and other issues, to achieve the effect of improving the safety of medication, facilitating transportation and storage, and meeting the needs of clinical medication

Inactive Publication Date: 2021-06-25
HAINAN STAR PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Terbutaline sulfate has poor stability and needs to be protected from light and kept in airtight storage
Terbutaline sulfate contains resorcinol groups, and the resorcinol groups turn pink when exposed to light, air or contact with iron ions, so terbutaline sulfate is unstable and easily affected by metal ions, Effects of oxygen and light
Ipratropium bromide has poor stability and needs to be stored in the dark below 30°C

Method used

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  • Pharmaceutical composition for treating respiratory system diseases and preparation method thereof
  • Pharmaceutical composition for treating respiratory system diseases and preparation method thereof
  • Pharmaceutical composition for treating respiratory system diseases and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1a

[0037]

[0038]

[0039] According to the prescription in Example 1a, add dispersion medium (water for injection), stabilizer (ascorbic acid), osmotic pressure regulator (sodium chloride), albuterol, acetylcysteine, acidic pH regulator in the liquid preparation tank successively, After stirring evenly, use an alkaline pH regulator to adjust the pH, the temperature of the water for injection is 20°C, and the product is aseptically treated by the sterilization and filtration production process, and the whole process is filled with nitrogen and repacked.

Embodiment 2a

[0048]

[0049] According to the prescription in Example 2a, add dispersion medium (water for injection), stabilizer (ascorbic acid), osmotic pressure regulator (sodium chloride), albuterol, acetylcysteine, acidic pH regulator in the liquid preparation tank successively, After mixing evenly, use an alkaline pH regulator to adjust the pH, the temperature of the water for injection is 30°C, and the product is aseptically treated by the sterile filtration production process, and the whole process is filled with nitrogen for sub-packaging.

Embodiment 3a

[0051]

[0052]

[0053]According to the prescription in Example 3a, add dispersion medium (water for injection), stabilizer (ascorbic acid), osmotic pressure regulator (sodium chloride), albuterol, acetylcysteine, acidic pH regulator in the liquid preparation tank successively, After mixing evenly, use an alkaline pH regulator to adjust the pH, the temperature of the water for injection is 40°C, and the product is aseptically treated by the sterile filtration production process, and the whole process is filled with nitrogen for sub-packaging.

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PUM

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Abstract

The invention discloses a pharmaceutical composition for treating respiratory system diseases and a preparation method thereof. The composition comprises the following components: a bronchiectasis agent, acetylcysteine, a stabilizer, an osmotic pressure regulator, a pH regulator, a dispersion medium and inert gas, wherein the bronchiectasis agent is a beta2 adrenergic receptor agonist or an anti-choline drug. The stability of the pharmaceutical composition is improved by adding the stabilizer and filling the inert gas in the composition of the pharmaceutical composition so that the pharmaceutical composition is convenient to store, transport and use.

Description

technical field [0001] The invention relates to the field of drugs for respiratory diseases, in particular to a pharmaceutical composition for treating respiratory diseases and a preparation method thereof. Background technique [0002] Bronchodilators are a group of drugs commonly used in respiratory diseases, which can resist bronchoconstriction, expand bronchial smooth muscle, reverse airway obstruction, and relieve airway narrowing, mainly to relieve bronchospasm. When the airway is narrowed or narrowed, people will experience hypoxia, and the clinical symptoms are generally manifested as oppression, wheezing, liver disease, and irritability. Bronchodilators can be taken orally, inhaled, intravenously, etc. to dilate the spasm bronchi and improve breathing. [0003] Acetylcysteine ​​(Acetylcysteine) has been widely used clinically as an expectorant since the 1960s, and it is an expectorant with the most comprehensive mechanism of action in clinical practice. Since acet...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K45/06A61K31/198A61K47/18A61K47/22A61K47/04A61K9/08A61K31/137A61K31/46A61P11/00
CPCA61K45/06A61K31/198A61K47/183A61K47/22A61K47/02A61K9/08A61K31/137A61K31/46A61P11/00A61K2300/00
Inventor 徐志斌张颖卓张志强
Owner HAINAN STAR PHARM CO LTD
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