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 CO2Anti－solvent Method
高赵华 1储菲菲 2王聪聪 1陶钰婷 1占晶晶 1黄建 1王志祥1
作者信息
- 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
- 折叠
摘要
采用超临界CO2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.
Abstract
The indometacin particles were prepared by supercritical CO2anti－solvent technology. The prepara-tion 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Key words
supercritical anti－solvent mothod/Indometacin/particle/dissolution rate引用本文复制引用
基金项目
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)
出版年
2018
NETL
NSTL
维普
万方数据