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Process for preparing micropowdered salbutamol sulfate

A salbutamol sulfate crystallization technology, which is applied in the field of micronized salbutamol sulfate crystals, can solve the problems that there is no rotary packed bed salbutamol sulfate, it is difficult to realize industrialization, and the operation equipment is complicated, etc., and achieve micro-mixing and mass transfer process enhancement, particle size Effect of distribution narrowing and controllable nucleation process

Inactive Publication Date: 2005-09-14
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 1

[0027] Adopt commercially available salbutamol sulfate raw material medicine, such as Figure 4 As shown in the electron microscope photo, the salbutamol sulfate raw material drug is rod-shaped particles with a short diameter of 5-20 μm and uneven particle size. Salbutamol sulfate raw material medicine is dissolved in water, is mixed with the salbutamol sulfate raw material solution A that concentration is 0.25g / ml (being about 95% of saturation concentration of salbutamol sulfate in water under this temperature condition). Adopt liquid-liquid rotary packed bed, by adjusting the frequency regulator to 30 Hz, determine that the rotation speed of the rotary packed bed is about 1800rpm, adopt a round hole liquid distributor, enter the small liquid spray hole of salbutamol sulfate crystallization raw material liquid a to be Φ0.5 ×9; the large-volume injection hole entering the anti-solvent b (acetone) is Φ1.44×9. Adopting the ratio of the flow rate of antisolvent b and salbutamol...

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.

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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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Patent Type & Authority Patents(China)
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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