超临界抗溶剂法制备吲哚美辛微粒的工艺研究  

Preparation Process of Indometacin Particles by Supercritical CO_2 Anti-solvent Method

作　　者：高赵华 储菲菲 王聪聪 陶钰婷 占晶晶 黄建 王志祥[1] Gao Zhaohua;Chu Feifei;Wang Congcong;Tao Yuting;Zhan Jingjing;Huang Jian;Wang Zhixiang(Department of Pharmaceutical Engineering,China Pharmaceutical University,Jiangsu Nanjing 210009;Hangzhou Zhongmei Huadong Pharmaceutical Co.,Ltd,Zhejiang Hangzhou 31000)

机构地区：[1]中国药科大学制药工程教研室,江苏南京210009 [2]杭州中美华东制药有限公司,浙江杭州310000

出　　处：《化工时刊》2018年第5期6-10,共5页Chemical Industry Times

基　　金：国家基础科学人才培养基金国家级大学生创新创业训练计划项目(J1030830)

摘　　要：采用超临界CO_2抗溶剂法制备吲哚美辛微粒,以微粒的体积平均粒径为评价指标,在单因素试验的基础上设计正交试验优选吲哚美辛微粒的制备工艺,并考察其体外溶出速率及溶出度。结果表明在最优条件下可制备得到粒径明显小于原料的吲哚美辛微粒,SEM显示吲哚美辛微粒呈纤维状;FTIR、DSC及XRD观察结果表明吲哚美辛微粒未发生化学结构的改变;体外溶出测试显示吲哚美辛优选工艺微粒的溶出速率明和溶出度显高于原料药的溶出速率和溶出度。The indometacin particles were prepared by supercritical CO2 anti-solvent technology. The preparation process of indometacin particles was optimized on the basis of single factor experiments using the average volume particle size as evaluation index through orthogonal test design. The in vitro dissolution rate was investigated. Under the optimum conditions,the volume average particle size was obviously smaller than that of ingredient. And the shapes of indometacin were fiber. FTIR,DSC and XRD analyses showed that the chemical structure did not change and the in vitro dissolution rate of indometacin particles of the optimum process was significantly larger than that of the ingredient.

关 键 词：超临界抗溶剂法 吲哚美辛 微粒 溶出速率 

分 类 号：TQ460.1[化学工程—制药化工]