超临界CO_2抗溶剂法制备头孢呋辛酯微粒的工艺研究  

Preparation of cefuroxime axetil particles by supercritical CO_2 antisolvent technology

作　　者：周敦晖[1] 乐龙[1] 王志祥[1] 党蓓蕾[1] 颜庭轩[1] 黄德春[1] 

机构地区：[1]中国药科大学制药工程教研室,南京210009

出　　处：《中国药科大学学报》2013年第6期596-599,共4页Journal of China Pharmaceutical University

基　　金：江苏省自然科学基金资助项目(No.BK2012763);中央高校基本科研业务费专项资金资助项目(No.JKY2011026)~~

摘　　要：采用超临界CO2抗溶剂法制备头孢呋辛酯微粒,以体积平均粒径为主要评价指标,在单因素实验的基础上设计正交试验优选制备头孢呋辛酯微粒的工艺,并对优选工艺组合进行粒度分布、扫描电镜、红外吸收光谱法(IR)及差示扫描热量法(DSC)的表征。正交试验得到的优选工艺为:结晶压力10 MPa,结晶温度50℃,头孢呋辛酯质量浓度6 mg/mL。在此工艺下制得的微粒体积平均粒径为6.729μm,IR与DSC分析表明头孢呋辛酯微粒的化学结构没有发生变化,热力学性质发生了变化,经过处理的头孢呋辛酯变为无定型。Cefuroxime axetil micro particles were prepared by using supercritical CO2 anti-solvent technology. With volume average particle size as the main evaluation, on the basis of single factor experiments orthogonal experimental design was used to optimize the preparation process of cefuroxime axetil particles. The experiments such as particle size distribution, scanning electro microscope analysis （ SEMA）, infrared spectrum （IR） and dif- ferential scanning calorimetry （DSC） were used to analyze the particles. The orthogonal experimental optimization process conditions were set as follows： crystallization pressure 10 MPa, crystallization temperature 50℃ and mass concentration of cefuroxime axetil 6 mg/mL, Under the optimum conditions, the volume average particle size was 6. 729μm, IR and DSC analysis showed that the chemical structure didn＇t change but the thermodynamic proper- ties of eefuroxime axetil might transfer transform to amorphous.

关 键 词：超临界CO2抗溶剂法 头孢呋辛酯 微粒 体积平均粒径 

分 类 号：TQ465[化学工程—制药化工]