摘要：利用自制的超临界流体抗溶剂装置,以多肽化合物为模型药物,研究压力、温度、进样速率和样品浓度等工艺参数对微粉粒径的影响,并采用扫描电镜、热重分析仪、X射线衍射仪等对制备的微粉进行表征。结果表明:压力、温度和样品浓度3个工艺参数对微粉的粒径没有显著性影响,微粉微观形貌主要为球形;微粉热稳定性未发生明显变化;微粉主要为无定形结构;制备得到空气动力学粒径约为1. 0μm的微粉,符合吸入式给药对微粉粒径的要求。

关键词：吸入式给药；超临界流体抗溶剂；多肽化合物；微粉

Abstract: In this paper，the polypeptide powder was prepared by an experimental apparatus for supercritical antisolvent process，and the effects of process parameters including pressure，temperature，flow rate and concentration on the particle size were investigated experimentally．The characteristics of the powder were carried out by SEM，TGA and XＲD．The results show that there is no signifigant effect of pressure，temperature and concentration on particle size and the morphology of micro-particles prepared is mainly spherical．There is no significant change in the thermal stability of micro-powder．The powder is mainly amorphous structure．The aerodynamic particle size of the powder is about 1．0 μm，which is suitable for inhalation delivery system． 

Keywords: inhalation drug delivery; supercritical antisolvent process; polypeptide; microparticles