Process for producing salbutamol sulfate fine powder

[0019] Weigh 0.4g of salbutamol sulfate raw material and dissolve it in 5ml of water, then add 80ml of dimethyl sulfoxide, mix with ultrasonic, and filter to obtain a clear solution; set the system parameters of supercritical recrystallization equipment: temperature 45°C, pressure 150bar, CO 2 The flow rate is 20g / min, the CO 2 After pumping into the heater, enter the crystallization tank until the system is balanced; pump the above-mentioned salbutamol sulfate solution into the crystallization tank at a flow rate of 1ml / min; stop the input of the salbutamol sulfate solution, keep the system state, and continue to feed CO 2 For 30-40 minutes, it is used to dry the crystallization of salbutamol sulfate and remove the residual solvent in the crystallization tank to obtain fine powder of salbutamol sulfate. The obtained above-mentioned fine powder was observed by SEM, and the results showed that the particle size of albuterol sulfate micropowder was round and uniform, with an a

[0021] The pressure, temperature and flow in the preparation method and process parameters are all the same as in Example 1, and only the preparation method of salbutamol sulfate solution is changed, that is, 0.4 g of salbutamol sulfate is directly dissolved in 120 ml of dimethyl sulfoxide. The obtained fine powder was observed by SEM, and the results showed that the appearance of the obtained product was similar to that of Example 1, but the average particle size of the crystals was about 5 μm; as measured by a particle size distribution analyzer, 90% of the particles had a particle size within 8 μm. .

[0023] The pressure, flow rate and solution concentration in the preparation method and process parameters are the same as in Example 1, only the temperature in the crystallization tank is changed to 55°C. The obtained above-mentioned fine powder is observed by SEM, and the result shows that: the appearance of the obtained product is similar to that of Example 1, but the crystal is rod-shaped, and the average particle diameter of the long diameter is about 7 μm; measured by a particle size distribution analyzer, 90% of the particles are The diameter is within 13 μm.