Preparation method of salbutamol sulfate aerosol inhalation solution

A salbutamol sulfate, atomized inhalation technology, applied in the field of salbutamol sulfate atomized inhalation solution, can solve the problems of low production quality and achieve the effect of improving production quality

Inactive Publication Date: 2014-12-24
SHANGHAI XINYI JINZHU PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The current production of salbutamol sulfate nebulized inhalation solution is of low quality

Method used

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Effect test

Embodiment Construction

[0013] The manufacture method of salbutamol sulfate atomized inhalation solution of the present invention comprises the following steps:

[0014] Step 1: Add 700,000 ml of water for injection into the spare closed preparation tank, and pass through nitrogen for 60 minutes to detect that the residual oxygen rate of the water for injection is ≤1.3mg / L, and the water temperature is controlled at 25-30°C; add to the preparation tank Add 280,000 ml of the above-mentioned water for injection, add salbutamol sulfate and sodium chloride, and stir to dissolve. Since salbutamol is easy to oxidize, nitrogen protection should be passed first, and the related substances of this product will affect the temperature, so the water temperature should be strictly controlled.

[0015] Step 2, dissolving benzalkonium chloride with hot water for injection in advance; adding the benzalkonium chloride solution into the above-mentioned preparation barrel, and stirring evenly;

[0016] Step 3, add nit...

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Abstract

The invention discloses a preparation method of a salbutamol sulfate aerosol inhalation solution. The preparation method comprises the following steps: S1, adding 700 thousand ml of water for injection in a hermetic preparation tank for later use; S2, dissolving benzalkonium chloride with hot water for injection in advance, adding a benzalkonium chloride solution into a preparation barrel, and uniformly stirring; S3, adding water for nitrogen filling injection to 320 thousand ml and stirring for 15 minutes to be uniformly stirred; S4, adding water for nitrogen filling injection to full dose, and stirring for 15 minutes to be uniformly stirred; S5, filtering with a 0.35 mu m polyether sulfone microporous filtration membrane until the solution is clarified; S6, sampling and testing the content and pH value of an intermediate, covering the preparation barrel, and introducing nitrogen into the liquid medicine to protect; and S7, filtering the liquid medicine in a liquid storage barrel by a 0.22 mu m polyether sulfone microporous filtration membrane, sampling and examining visible foreign matters, and inputting the qualified visible foreign matters into a liquid storage container for encapsulation. The production quality of the salbutamol sulfate aerosol inhalation solution is effectively improved.

Description

technical field [0001] The invention relates to a salbutamol sulfate atomized inhalation solution, in particular to a preparation method of the salbutamol sulfate atomized inhalation solution. Background technique [0002] According to the new standards in the first supplement of the 2010 edition of the "Chinese Pharmacopoeia" (implemented from October 1, 2012), the analysis of related substances was carried out on the salbutamol sulfate nebulized inhalation solution. During the placement process, it was found that the related substances would increase with the prolongation of time (both the single largest impurity and the total impurity would increase). After the small sample test, a series of investigations were carried out on the sample, such as nitrogen filling, light protection, partial acidity and partial alkalinity. Compared with the normal process, except that the total impurities of related substances in the sample were found to increase significantly under alkali...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/72A61K31/137
Inventor 徐欣
Owner SHANGHAI XINYI JINZHU PHARMA
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