阿莫西林分散片的稳定性研究

Study on the stability of Amoxicillin Dispersible Tablets

目的考察阿莫西林分散片的稳定性,初步确定其贮藏条件和有效期限。方法对制备的阿莫西林分散片以性状、分散均匀性、标示量及释放度等质量指标为标准,对其稳定性进行研究。通过影响因素试验、加速试验及长期留样试验观察其质量变化情况,并通过经典恒温法推测其有效期。结果阿莫西林分散片在高温和高湿条件下稳定性较差,但对光照稳定;加速试验和长期留样试验中各项质量指标均符合质量要求,有效期可达2年。结论阿莫西林分散片采用双铝包装,并置阴凉干燥处保存,在有效期内质量稳定。

Objective To study the stability of Amoxicillin Dispersible Tablets（ADT） and determine their storage conditions and the expiration date preliminarily.Methods The expiration date was speculated through the study of the stability of prepared ADT based on quality indexes such as character,scattered uniformity,labeling quantity and release and observing its quality changes by the influence factors test,accelerated test and long-term retention sample test and the classic method of constant temperature.Results ADT was less stable with high temperature and high humidity but of light stability.Various quality indexes were met the quality requirements in the accelerated test and long-term sample test and the validity could be up to two years.Conclusion With double aluminum packaging and a cool,dry storing place,the quality of ADT is stable during a validity period.