反应结晶法制备超细环丙沙星颗粒

Preparation of micronized ciprofloxacin by reactive precipitation

采用反应结晶法进行了环丙沙星微粉化实验,考察了反应物摩尔比,搅拌转速,氢氧化钠浓度等各个因素对微粉化过程的影响。实验得到适宜的微粉化条件为：盐酸环丙沙星与氢氧化钠的摩尔比为8∶1-10∶1,搅拌转速控制在15000 r/min左右,氢氧化钠浓度约为0.01 mol/L,对微粉化后的粉体分别用扫描电镜,X射线衍射分析和红外进行表征,结果表明制备所得到的环丙沙星干粉粒度约为1-2μm,结构和晶型均没有改变。

A simple method for formation of micronized ciprofloxacin particles by reactive precipitation has been developed. The effects of varying five critical parameters-molar ratio of reactants, concentration of NaOH solution, reaction temperature, stirring speed and drying method-on particle size and morphology are described. The optimum conditions for preparation of micronized ciprofloxacin were found to be： molar ratio of reactants in the range 8 - 10, stirring speed 15000 r/min, and concentration of NaOH 0.01 mol/L. The particle size of ciprofloxacin dry power shown by SEM can reach 1 - 2 μm. IR spectroscopy and X-ray diffraction showed that the molecular structure and crystallinity of ciprofloxacin did not change during the process.