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Salbutamol sulfate solution composition for inhaling and preparation method thereof

A technology of salbutamol sulfate and salbutamol, which is applied in the direction of drug combination, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., and can solve problems such as inability to withstand high-temperature sterilization, bronchoconstriction, and high content of preparation substances

Inactive Publication Date: 2016-08-10
HEBEI RENHE YIKANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] CN1720036A, CN101204386A, CN105326789A, CN102258504A etc. have carried out research on the solution preparation of albuterol sulfate or combined with ambroxol hydrochloride, but there are many prescription components, complex preparation process, high content of related substances in the preparation, low storage stability, etc. shortcoming
For example, the salbutamol sulfate atomized inhalation solution disclosed by CN104224760A is filled with nitrogen in water for injection, not only to strictly control the amount of residual oxygen (it should be pointed out that under industrial production conditions, it is difficult to control the amount of residual oxygen to≤1.3ppm Large), also need to strictly control the water temperature, and can not withstand high temperature sterilization, antimicrobial preservative benzalkonium chloride should be added to the liquid medicine, and repeated use of medicines containing benzalkonium chloride may cause abnormal bronchoconstriction

Method used

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  • Salbutamol sulfate solution composition for inhaling and preparation method thereof
  • Salbutamol sulfate solution composition for inhaling and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Embodiment 1 sucks albuterol sulfate solution of the present invention

[0037] prescription:

[0038] Salbutamol sulfate (calculated as salbutamol) 2.5g,

[0039] Edetate Disodium 0.2g,

[0040] Add water for injection to 2.5L.

[0041] Preparation:

[0042] Fill the water with nitrogen or carbon dioxide, add the raw and auxiliary materials and stir to dissolve, add water to the full amount; filter and sterilize, fill with sterile nitrogen, pack 2.5ml / bottle, pack, and get ready.

Embodiment 2

[0043] Embodiment 2 sucks albuterol sulfate solution of the present invention

[0044] prescription:

[0045] Salbutamol sulfate (calculated as salbutamol) 5g,

[0046] Edetate Disodium 3g,

[0047] Add water for injection to 2.5L.

[0048] Preparation:

[0049] Fill the water with nitrogen or carbon dioxide, add raw and auxiliary materials and stir to dissolve, add water to the full amount; filter and sterilize, 2.5ml / bottle, sterilize at 121°C for 15 minutes after packaging, pack, and get ready.

Embodiment 3

[0050] Embodiment 3 inhalation of the present invention uses albuterol sulfate solution

[0051] prescription:

[0052] Salbutamol sulfate (calculated as salbutamol) 10g,

[0053] Edetate Disodium 5g,

[0054] Add water for injection to 10L.

[0055] Preparation:

[0056] 10ml / support, with embodiment 1.

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Abstract

The invention provides a salbutamol sulfate solution composition for inhalation and a preparation method thereof. The salbutamol sulfate solution for inhalation of the present invention contains salbutamol sulfate, edetate disodium and water for injection, and is filled with nitrogen or carbon dioxide during its preparation. The salbutamol sulfate solution composition for inhalation of the present invention has the advantages of simple prescription, low content of related substances, high storage stability, suitable for industrial production and the like.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a salbutamol sulfate solution composition for inhalation and a preparation method thereof. Background technique [0002] Salbutamol sulfate (Salbutamol sulfate), also known as albuterol, is a highly selective bronchial smooth muscle β2-adrenoceptor agonist. It has clear activity on relaxing bronchial smooth muscle and relieving bronchial smooth muscle spasm. The agonistic effect of the receptor is weak, and it is a safe and effective anti-asthma drug. Clinically, albuterol sulfate solution for inhalation is often used to treat various types of airway obstruction, such as bronchial asthma, chronic obstructive pulmonary disease (COPD), asthmatic bronchitis and bronchospasm in patients with emphysema. The molecular formula of salbutamol sulfate is (C 13 h 21 NO 3 ) 2 ·H 2 SO 4 , the structural formula is as follows: [0003] [0004] At present, salbut...

Claims

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Application Information

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IPC IPC(8): A61K9/72A61K9/08A61K31/137A61P11/06A61P11/00
CPCA61K31/137A61K9/0078A61K9/08A61K47/183
Inventor 牛菁菁
Owner HEBEI RENHE YIKANG PHARMA
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