摘要
目的制备不含氟利昂的硫酸沙丁胺醇气雾剂,并进行处方优化.方法以性状、雾滴(粒)分布、含量等作为评价指标进行处方筛选,并进行加速稳定性考察.结果经处方优化确定的硫酸沙丁胺醇气雾剂其性状、雾滴(粒)分布、含量等指标均符合规定,加速稳定性试验结果显示,本品质量稳定.结论所选处方工艺稳定可靠,适合生产.
Objective To prepare salbutamol sulfate aerosol not containing freon,and optimize its preparation prescription.Methods Use characters,droplets（particles）distribution,content and other traits as the evaluation index to screen the prescription and investigate the accelerated stability.Results The results of above indexes determined by the prescription optimization of salbutamol sulfate aerosol were consistent with the requirements.The accelerated stability test showed that the quality of the product was stable.Conclusion The selected prescription process was stable and reliable,and it was suitable for production.
出处
《齐鲁药事》
2012年第7期377-378,共2页
qilu pharmaceutical affairs
关键词
硫酸沙丁胺醇
气雾剂
四氟乙烷
制备
Salbutamol sulfate
Aerosol
Tetrafluoroethane
Preparation
