咽速康气雾剂变更辅料对生产工艺及质量的影响  

Effects of Excipient Change on Productive Technology and Quality of Yansukang Aerosols

作　　者：常新全 杨娜[2] 宋潇[2] 刘玉川[2] 李飒[2] 李昌福[2] 

机构地区：[1]中国药材公司,北京102600 [2]华颐药业有限公司,北京102600

出　　处：《中国实验方剂学杂志》2013年第18期48-51,共4页Chinese Journal of Experimental Traditional Medical Formulae

摘　　要：目的:考察抛射剂变更对咽速康气雾剂生产工艺及质量的影响。方法:通过观察药液与抛射剂混合液的均一性筛选咽速康气雾剂处方,以总揿次数为指标优选四氟乙烷灌装量,以泄漏率、残留量、外观等为指标,对比咽速康气雾剂变更抛射剂前后的质量。结果:药液与抛射剂混合液无分层现象,均一性良好。四氟乙烷灌装量4.5 g时,总揿次数与变更前基本一致。泄漏率、残留量、体外喷雾雾滴粒度分布、模拟体内微细粒子分布、外观等与变更前均无显著性差异。结论:变更抛射剂和定量阀门后,产品处方无需调整。生产工艺需将四氟乙烷的灌装量由2.5 g调至4.5 g。生产工艺稳定可控,药品质量具有一致性。Objective： To investigate productive technology and quality of Yansukang aerosols after changed excipient.Method： Through observing uniformity of mixture of liquid and propellant,Yansukang aerosol prescription was screened,with total press times as index to optimize tetrafluoroethane filling volume,leakage rate,residual,appearance were taken as qualitative and quantitative indicators to make comparative study on Yansukang aerosols before and after propellant changed.Result： Mixture of liquid and propellant was homogeneous without stratification phenomenon;When tetrafluoroethane filling volume was 4.5 g,total press times was almost the same with that before propellant changed;Leakage rate,residual,droplet size distribution of in vitro spray and simulated distribution of in vivo micro-particles distribution,appearance and so on all had no significant difference.Conclusion： Product prescription was not necessary to be adjusted after change of propellant and quantitative valve.Filling volume of tetrafluoroethane should be adjusted from 2.5 g to 4.5 g.Productive technology was controllable and stable,quality of Yansukang aerosols was consistent before and after propellant changed.

关 键 词：咽速康气雾剂 二氯二氟甲烷 四氟乙烷 生产工艺 

分 类 号：R283.6[医药卫生—中药学] R943[医药卫生—中医学]