草酸艾司西酞普兰片有关物质及其影响因素的研究

目的 考察温湿度、辅料、包装材料以及水活度对草酸艾司西酞普兰片有关物质的影响，为确定制剂生产工艺和储存条件提供参考。方法 采用高效液相色谱（HPLC）和水活度测定仪分别测定样品不同试验条件下的有关物质和水活度。结果 高温高湿条件下样品降解明显加快，微晶纤维素、二氧化硅和硬脂酸镁3种辅料对可加速样品降解，包装材料的优劣直接影响样品稳定性。结论 建议企业控制生产工艺的水分，处方中减少微晶纤维素、硬脂酸镁和二氧化硅的使用量，采用密封性好的包装材料或添加干燥剂，贮存过程中避免高温高湿。

Study on related substances of Escitalopram Oxalate Tablets and its influencing factors

Objective To investigate the effects of temperature,humidity,excipient,packaging materials and water activity on related substances in Escitalopram Oxalate Tablets and provide reference for determining preparation process and storage conditions.Methods The related substances and water activity under different experimental condition of the samples were analyzed by HPLC and water activity tester.Results Degradation of the sample was significantly faster under high temperature and humidity conditions,Microcrystalline cellulose, silica and magnesium stearate could accelerate sample degradation.The quality of the packaging material directly affected the stability of the sample.Conclusion It was recommended that the companies should control water in production process,reduce the use of MCC,silica and magnesium stearate,use good seal packaging material or add desiccant, avoid high temperature and humidity during the storage process.