超临界CO2抗溶剂法制备微粉化阿西美辛
Chinese Journal of Pharmaceuticals(2017)
Abstract
以粒径为主要评价指标,采用单因素试验和正交设计,优化了超临界CO2抗溶剂法制备微粉化阿西美辛的工艺条件.所得优化参数为:溶剂为丙酮∶二氯甲烷(1∶1),结晶压力16 MPa,结晶温度40℃,阿西美辛浓度9 mg/ml.优化得到的微粉化阿西美辛粒径降至6.02 μm;扫描电镜、红外、差示量热扫描等分析结果表明,微粉化阿西美辛的理化性质与原料药相比没有发生明显变化.并且,微粉化阿西美辛在水中10 min的溶出率超过20%,80 min时接近80%,溶出性能相较于原料药得到明显改善.
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