右佐匹克隆口崩片稳定性研究

Study on stability of eszopiclone orally disintegrating tablets

目的了解右佐匹克隆口崩片与时间相关的药物质量变化规律,为右佐匹克隆口崩片的生产、贮存及有效期的确定提供依据。方法对右佐匹克隆口崩片在不同温度、湿度和光线的条件下进行稳定性研究。结果右佐匹克隆口崩片3批模拟上市包装,经加速试验6个月,各项指标未见显著变化,符合质量标准要求。经24个月长期试验考察,各项指标均未见显著变化,符合质量标准要求。结论右佐匹克隆口崩片中各项指标在观测时间内符合要求,制剂有效期暂定为2年。

Objective To understand the change rule of the quality of eszopiclone orally disintegrating tablets overtime,and provide evidence for its production,storage and period-of-validity determination. Methods The stability ofeszopiclone orally disintegrating tablets under different temperature,humidity and light were investigated. ResultsThe simulated package of the third batch of eszopiclone orally disintegrating tablets was subjected to accelerated test（0month）,and all indexes met the requirements of quality standard compared with those in accelerated test for 6 months,without significant changes. A long-term test for 24 months showed that all indexes met the requirements comparedwith those in accelerated test（0 month）. Conclusion The period of validity is tentatively considered as two years.