采用结晶法制备吉非罗齐超细粉体,考察了表面活性剂种类、复分解反应温度和搅拌转速对药物颗粒形态和粒径的影响。通过光镜、扫描电镜、X射线衍射、热重及差热分析、红外光谱、比表面积分析和溶出试验表征产品性质。所得颗粒形貌规则,粒径分布范围为0.5-2μm,比表面积为9.2263m^2/g,120min时体外溶出速率是原药的4倍。
Ultrafine powder of gemfibrozil was prepared by the crystallization. The effects of surfactants, metathetical reaction temperature and stirring speed on the morphology and size of particles were investigated. The properties of the ultrafine powder were characterized by optical microscope, scanning electron microscope, X-ray diffraction, thermogravimetry and differential scanning calorimetry, infrared spectrum, specific surface area analysis and dissolution test. The particles were spherical and had a size distribution from 0.5 to 2μm with the specific surface area of 9.2263m^2/g. The in vitro dissolution ofultrafine powder at 120min was about 4 times as fast as that of the bulk drug.