以沙丁胺醇和硫酸为反应物,在异丙醇溶液中采用反应结晶法制备超细硫酸沙丁胺醇颗粒。对影响产物粒度和产率的因素,如:硫酸浓度、反应温度、搅拌转速、反应时间等进行了系统研究。实验结果表明:当硫酸浓度为1.0mol.L-1、反应温度为15℃、搅拌转速为900r.min-1、反应时间为10min时,可以得到短轴为50~60nm、长径比为20~35且粒度分布较窄的针状硫酸沙丁胺醇颗粒。产品经IR、XRD等验证,符合中国、英国药典的要求,纯度大于98%。 Using salbutamol and sulfuric acid as reactants, the ultrafine salbutamol sulfate granules were prepared by reaction crystallization in isopropanol solution. The factors affecting the product size and yield, such as: sulfuric acid concentration, reaction temperature, stirring speed, reaction time were studied systematically. The experimental results show that when the concentration of sulfuric acid is 1.0mol.L-1, the reaction temperature is 15 ℃, the stirring speed is 900r.min-1 and the reaction time is 10min, the short axis is 50-60nm and the aspect ratio is 20 ~ 35 and narrower particle size distribution of acicular sulfate salbutamol particles. Products by IR, XRD and other tests, in line with China, the United Kingdom Pharmacopoeia requirements, purity greater than 98%.