硫酸沙丁胺醇吸入气雾剂稳定性研究

目的考察硫酸沙丁胺醇吸入气雾剂的稳定性。方法根据《原料药物与制剂稳定性试验指导原则》及硫酸沙丁胺醇吸入气雾剂质量标准,以硫酸沙丁胺醇吸入气雾剂的性状、沙丁胺酮、有关物质、递送剂量均一性、微细粒子剂量、含量测定、微生物限度为指标进行考察,分别进行影响因素试验、加速试验和长期试验,通过观察各指标的变化评价制剂的稳定性,同时通过试验建立药品的有效期。结果硫酸沙丁胺醇吸入气雾剂3批模拟上市包装,经影响因素试验、加速试验和长期试验,各项指标未见显著变化,符合质量标准要求。3批硫酸沙丁胺醇吸入气雾剂样品的预测有效期均大于60个月。结论硫酸沙丁胺醇吸入气雾剂各项指标在观测时间内符合要求,有效期暂定为24个月。

Study on the Stability of Salbutamol Sulfate Inhalation Aerosol

Objective To investigate the stability of salbutamol sulfate inhalation aerosol.Methods According to the Guidelines for the Stability Test of Raw Drugs and Preparations and the quality standard of salbutamol sulfate inhalation aerosol,the characteristics,albuterone,related substances,uniformity of delivered dose,fine particle dose,content measurement and microbial limits of salbutamol sulfate inhalation aerosol were used as indicators to conduct evaluations,and influencing factor test,accelerated test,and long-term test were performed.The stability of the preparation was evaluated by observing the changes in each indicator,and the validity period of the drug was established through the test.Results The three batches of salbutamol sulfate inhalation aerosol were simulated and packaged.After the influencing factors test,accelerated test and long-term test,the indicators did not change significantly and met with the quality standards.The three batches of salbutamol sulfate inhalation aerosol samples were all predicted to have a validity period of more than 60 months.Conclusion The indicators of salbutamol sulfate inhalation aerosol meet the requirements within the observation time,and the validity period is tentatively set at 24 months.