CIESC Journal

• 综述与专论 •    下一篇

超临界辅助雾化制备适于气溶胶给药的药物微粒

朱自强;关怡新;姚善泾   

  1. 浙江大学化学工程与生物工程学系,浙江 杭州 310027

  • 出版日期:2005-02-25 发布日期:2005-02-25

Micronization of drugs suitable for aerosol delivery by supercritical fluid assisted atomization

ZHU Ziqiang;GUAN Yixin;YAO Shanjing

  

  • Online:2005-02-25 Published:2005-02-25

摘要: 超临界流体辅助雾化法(SAA)是一种新型的以超临界流体为基础的固体微粒制备工艺,既能用于水溶性,也可用于脂溶性的溶质.该工艺能制备出适用于气溶胶给药要求的微粒,预期可在药物行业内得到应用.综述了SAA过程的形成和特色、工艺流程和操作条件以及相应的造粒结果.评述了6种药物微粒的粒度、粒度分布及其形貌.经SAA加工后的药物质量未见变化,目前该工艺已进入中试阶段,展示出较快的发展速度.比较了SAA和现有的主要以超临界流体为基础的微粒制造工艺.展望了加强应用基础研究的必要性,进一步分析了SAA的机理和过程实质.

Abstract: Supercritical fluid assisted atomization (SAA) is a promising process in producing micronic particles of controlled diameter that uses supercritical fluids to assist atomization processes.This technique allows drug micronization by using water as liquid solvent,but can work by using organic solvents too.Very sharp particle size distribution (PSD) can be obtained, that lies in the particle size range of aerosolizable drugs.The characteristics and schematic representation of the SAA process were described in detail.Results on six kinds of pharmaceutical compounds were illustrated,including particle size (PS), PSD and morphology while varying process parameters in the process respectively.No chemical modifications occurred during the SAA process.The process was developed on the pilot scale, showing great potential in pharmaceutical industry. SAA and several supercritical fluids based techniques (RESS, SAS, PGSS) for the production of micronic and nanometric particles of pharmaceutical compounds were compared. Finally the necessity to emphasize fundamental research was prospected and the mechanism and process nature in SAA were analyzed.