摘要
目的 :采用喷雾干燥法制备胰岛素吸入粉雾剂 ,建立粉体性质评价指标 ,对吸入粉雾剂进行考察 ,并对各指标间的相关性进行初步研究。方法 :采用中国药典 2 0 0 0版附录XH的装置测定粉末的体外有效部位沉积量 ,扫描电镜观察粉末的粒子形态 ,激光粒度测定仪测定粒度分布。同时测定粉体的固密度和平均粒径从而推算粉末粒子的空气动力学径。测定粉末的休止角 ,水溶性 ,雾化特性以考察粉末的流动性 ,安全性等。结果 :制备各粉体的粉末性质有较大差异 ,其中有效部位沉积量与粉末粒子的空气动力学径成良好的相关性 ,同时也受粉末雾化特性的影响。结论 :所建立的各个评价指标可有效反映粉末的个体及整体特性 。
AIM:To prepare insulin dry powder inhalations by spray-drying. The evaluation methods of powder properties were established and the relationship between these values was studied.METHOD:The vitro aerosol deposition of insulin inhalation was determined according to Chinese Pharmacopoeia 2000. Particles' morphology and size were observed by scanning electronic microphotograph and Malvern Mastersizer.The aerodynamic diameter was calculated in terms of particle diameters and tapped densities. The fluidity and safety of the powders were evaluated by the determination of repose angle and solubility.RESULT:The deposition fraction of all the powders varied and showed strong correlation with aerodynamic diameter of particles .The deposition fraction was also influenced by aerosolization properties of the powders.CONCLUSION:The particle and powder characteristics can be well evaluated by the methods mentioned in the articles in which will be provided some instructions in carrier-screening.
出处
《中国药科大学学报》
CAS
CSCD
北大核心
2004年第5期424-428,共5页
Journal of China Pharmaceutical University
关键词
胰岛素
吸入粉雾剂
粉体性质
处方筛选
Insulin
Dry powder inhalations
Powder properties
Formula design
