反应结晶法制备微粉化萘普生的研究

Micronization of naproxen particles by precipitation

采用反应结晶法对萘普生进行微粉化实验研究。系统考察了温度、搅拌速度、盐酸滴加速度、药物浓度和酸溶液体积用量对反应结晶颗粒的形貌和粒度的影响。实验结果表明,在温度15℃、搅拌速度1500 r/min、盐酸溶液滴加速度0.5 mL/min、药物浓度0.02 mol/L、盐酸溶液体积10 mL的条件下,可制得微粉化六边形片状萘普生药物颗粒,且产物的粒度和形貌可控。产品的XRDI、R分析表明,结晶过程对产物的晶形与化学性质均不产生影响。

This study proposed a simple method to prepare naproxen particles of microsize rage. The experimental parameters such as temperature, stirring speed, acid addition rate, concentration of naproxen solution and the ratio of acid and basic solutions were varied to investigate their effects on the particle size and morphologies. The results show that plate-like naproxen particles with a hexagon profile could be precipitated under the optimal con- ditions： temperature 15 ℃, stirring speed 1500 r/min, acid addition rate 0.5 mL/min, concentration of naproxen solution 0.02 mol/L and the of acid solution volume 10 mL. The particle size and morphology could be well controlled and the temperature lower than 15 ℃ was necessary to obtain monodispersed naproxen particles.