SAS和气流粉碎工艺制备的两种微粉化布地奈德及其气雾剂质量的比较研究

Comparative study on the quality of micronized budesonide and its aerosol by SAS and air jet pulverization

目的对超临界流体抗溶剂(SAS)和气流粉碎工艺制备的微粉化布地奈德及其气雾剂的质量进行比较研究。方法分别采用扫描电子显微镜和DSC法对粉体进行分析;激光粒度测定仪对气雾剂的粒径进行分析;HPLC法测定气雾剂的含量、每揿主药含量和雾粒分布。结果 SAS法比气流粉碎工艺制备的微粉粒度更小,分布更均匀,对应的气雾剂每揿主药含量差异小、雾粒药物量更高。结论 SAS法在吸入制剂的应用中具有更好的优越性和更广阔的前景。

Objective The quality of micronized budesonide and its aerosol made by supercritical anti-solvent（SAS） and air jet pulverization were studied comparatively in this article.Methods The power were analyzed by scanning electron microscopy and DSC.The particle size of aerosol was determined by the laser particle size analyzer.The particle size distribution,content of active ingredient and content of budesonide aerosol were measured by HPLC.Results The particle size of budesonide prepared by SAS technology was smaller and uniformly distributed than that prepared by air jet pulverization,and the particle size distribution was more uniformly and content of active ingredient was more of budesonide aerosols prepared by SAS technology.Conclusion SAS technology has more advantage and more extensive application prospect in inhalation preparation.