CHANG Xin-quan, YANG Na, SONG Xiao, et al. Effects of Excipient Change on Productive Technology and Quality of Yansukang Aerosols[J]. Chinese journal of experimental traditional medical formulae, 2013, 19(18): 48-51.
DOI:
CHANG Xin-quan, YANG Na, SONG Xiao, et al. Effects of Excipient Change on Productive Technology and Quality of Yansukang Aerosols[J]. Chinese journal of experimental traditional medical formulae, 2013, 19(18): 48-51. DOI: 10.11653/syfj2013180048.
Effects of Excipient Change on Productive Technology and Quality of Yansukang Aerosols
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.