沙丁胺醇包合物缓释片的稳定性研究

Study on Stability of Salbutamol-Ethylated β-Cyclodextrins Complexes Sustained Release Tablets

目的 确定沙丁胺醇包合物缓释片的有效期和贮存条件。方法 采用高温、高湿、光照、加速试验和室温留样考察。结果 沙丁胺醇包合物缓释片在高湿和光照下含量和释放度变化不大,高温下释放度变化较大。结论 沙丁胺醇包合物缓释片的有效期可暂定为3年,贮藏条件为密闭、阴凉处保存。

Aim To determine the expiry date and the storage co nd itions of salbutamol-ethylated β-cyclodextrins complexes sustained release tab lets.Methods Accelerated testing at high temperature,high humid ity and under strong light and long term testing at indoor temperature were carr ied out.Results The content and the release rate of salbutamol- ethylated β-cyclodextrins complexes sustained release tablets changed little a t high humidity and under strong light,the release rate at high temperature chan ged much.Conclusion The expiry date of salbutamol-ethylated β -cyclodextrins complexes sustained release tablets can be determined by 3 years temporarily.The storage conditions are keeping away from light,airtight and sto ring at cool places.