超临界抗溶剂造粒技术由于具有操作条件温和、制得的微粒有机溶剂残留少、微粒粒径和形态可控等优点,已广泛地应用于药物运输体系的研究当中。本文简要介绍了超临界抗溶剂造粒技术的基本原理、装置组成和基本分类;从技术发展、喷嘴改进、技术结合、产品收集等方面,详细阐述了GAS、ASES、SEDS、SEDS-PA、SpEDS、SAS-EM、SAS-IJ、连续式RESS以及RESAS等基于超临界流体抗溶剂原理的造粒技术及其装置的改进过程;然后对目前其中存在的颗粒团聚、产品收集难和装置资源没有充分利用等问题提出了可能的解决方案;最后从数学模型的建立和规模化两方面,对超临界抗溶剂造粒技术基础理论的完善及其装置的改进进行了展望。
With the great advantages,such as mild operating condition,less or no residual organic solvent and controllable particle size distribution and morphology of products,supercritical antisolvent(SAS) process for particle formation has been widely employed in drug delivery systems(DDS).The fundamental theory,compositions of apparatus and classification for particle formation technology based on SAS process were briefly introduced in this paper.Then the developments of particle formation technology and its apparatus based on SAS process,including the GAS,ASES,SEDS,SEDS-PA,SpEDS,SAS-EM,SAS-IJ,continuous RESS and RESAS processes,were summarized and addressed in more detail with respect to developments of technologies,improvements of nozzle,combinations of technologies and collections of products.The possible solutions for the existing problems such as the agglomeration of particles,difficulty in products collections,and failure in making full use of apparatus,were proposed.Finally,the prospect of development about basic theory in particle formation technology and improvements in apparatus based on SAS process were also presented from two aspects:development of mathematical model and scale-up of SAS process.