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Process for preparing micropowdered salbutamol sulfate

A technology of salbutamol sulfate and micronization, which is applied in chemical instruments and methods, preparation of organic compounds, preparation of aminohydroxy compounds, etc., can solve the problems of albuterol sulfate in a rotating packed bed, difficult to realize industrialization, complicated operation process, etc., Achieve the effects of micro-mixing and mass transfer process enhancement, particle size distribution narrowing, and nucleation process controllable

Inactive Publication Date: 2003-10-29
BEIJING UNIV OF CHEM TECH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although this method can control the particle size very well, the size of the obtained particles is between 1-5μm, but the operating equipment is relatively complicated, and a booster system and an expander are required
After solution expansion and particle precipitation, the separation of solvent and solid can be achieved by microporous plate filtration or direct extraction of solvent. The process often adopts intermittent operation or semi-continuous operation. The operation process is relatively complicated and it is difficult to realize industrialization.
There is no report that the anti-solvent recrystallization method is used to prepare salbutamol sulfate at present
But there is no report that rotating packed bed is used for preparing salbutamol sulfate at present

Method used

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  • Process for preparing micropowdered salbutamol sulfate
  • Process for preparing micropowdered salbutamol sulfate
  • Process for preparing micropowdered salbutamol sulfate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 2

[0029] The operating parameters are the same as in Example 1, except that the crystallization temperature is changed to 22°C. Observation by SEM shows that the appearance of the product is similar to that of Example 1, but the average particle size of the short diameter of the crystal is about 2 μm. At least 80% of the particles have a particle size of 1.0-4.0 μm.

Embodiment 3

[0031] The operating parameters are the same as in Example 1, except that the rotation speed of the rotating bed is changed to 1140rpm. Observation by SEM shows that the appearance of the product is similar to that of Example 1, but the average particle size of the short diameter of the crystal is about 4 μm. Among them, at least 90% of the particles have a particle size of 3.0-5.0 μm.

Embodiment 4

[0033] The operating parameters are the same as in Example 1, except that the volume flow ratio of the anti-solvent and salbutamol sulfate crystallization raw material solution is changed to be 8: 1. Observation by SEM shows that the product morphology is similar to that of Example 1, but the short diameter of the crystal is on average The particle size is about 2.5 μm. Among them, at least 90% of the particles have a particle size of 1.0-3.0 μm. Example 5

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Abstract

A process for preparing the micropowdered salbutamol sulfate includes mixing the solution of raw material containing salbutamol sulfate and acetone in filler layer of rotating filler bed, recrystallizing, filtering, washing and drying. Its advantages are high granularity uniformity, and controllable average granularity.

Description

technical field [0001] The invention relates to a method for preparing crystalline salbutamol sulfate from a raw material solution containing salbutamol sulfate, in particular using a rotating packed bed to prepare micronized salbutamol sulfate crystals with narrow particle size distribution and controllable average particle diameter. Background technique [0002] Salbutamol sulfate [1-(4-hydroxy-3-hydroxymethylphenyl)-2-(tert-butylamino)ethanol sulfate] is a potent and selective β 2 - receptor agonists. At present, due to its definite curative effect and convenient administration, salbutamol sulfate has become one of the main drugs clinically used for the treatment of respiratory diseases such as bronchospasm in patients with asthmatic bronchitis, bronchial asthma and emphysema. Salbutamol sulfate medicine is usually used in the market in the form of aerosol, capsule, sustained-release dispersible tablets, and sustained-release pellets. [0003] The conventional preparati...

Claims

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Application Information

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IPC IPC(8): C07C213/00C07C215/56
Inventor 陈建峰王玉红马静吉米·云
Owner BEIJING UNIV OF CHEM TECH
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