硫酸沙丁胺醇雾化吸入溶液冻融稳定性研究

Study on Freeze-thaw Stability of Salbutamol Sulfate Inhalation

为了使硫酸沙丁胺醇雾化吸入液在运输以及存储条件下有更好的稳定性,本研究采用反复冻融法考察了硫酸沙丁胺醇雾化吸入液冻融稳定性。将硫酸沙丁胺醇雾化吸入液置于冰箱(-10℃至-20℃)内放置两天,取出后再放入40℃稳定箱内两天,三次循环后取出,放置室温,观察其外观性状并检测其含量及有关物质变化。结果显示其外观性状,pH,含量以及有关物质等检查项均符合标准,溶液稳定性良好。硫酸沙丁胺醇雾化吸入液在运输以及冻融条件下有较好的稳定性。

In this experiment,the freeze-thaw stability of salbutamol sulfate aerosol inhalation solution was investigated by repeated freeze-thaw method.The salbutamol sulfate atomized inhalation solution was placed in a refrigerator (-10℃ to -20 ℃) for two days,taken out and placed in a 40 ℃ stable box for two days, taken out three times,placed at room temperature,and observed for appearance and Detect its content and related substances.The results showed that the appearance traits,pH,content and related substances were all in compliance with the standard,and the solution stability was good.