酒石酸伐尼克兰片上市包装材料的考察

Investigation on Package Materials for Varenicline Tartrate Tablet

目的筛选酒石酸伐尼克兰片合适的上市包装材料。方法酒石酸伐尼克兰片分别采用双铝包装、聚氯乙烯(PVC)/聚偏二氯乙烯(PVDC)铝塑泡罩包装、Aclar铝塑泡罩包装3种不同包装,进行加速试验考察6个月,在不同时间点检测样品的性状、水分、溶出度、含量和有关物质。结果加速试验6个月,双铝包装中酒石酸伐尼克兰片杂质C和总杂质分别为0.08%和0.13%;PVC/PVDC铝塑泡罩包装中酒石酸伐尼克兰片杂质C和总杂质分别为0.62%和0.78%;Aclar铝塑泡罩包装中酒石酸伐尼克兰片杂质C和总杂质分别为0.31%和0.38%。结论双铝包装的酒石酸伐尼克兰片质量最佳且包装成本相对较低,双铝包装是酒石酸伐尼克兰片的最佳上市包装。

Objective To screen suitable package materials for Varenicline tartrate tablet.Methods Varenicline tartrate tablet were packaged separately with double aluminum,PVC/PVDC,and Aclar aluminum plastic blister,and stored under accelerated condition for 6 months.The appearence,moisture,dissolution,content,and impurity were tested at different periods.Results At the 6 th month of the accelerated test,the impurity C and total impurity of Varenicline tartrate tablet were 0.08%and 0.13%in the double aluminum package.Conclusion The double aluminum packaging of Varenicline tartrate tablet has the best quality and relatively low cost of packaging.Double aluminum packaging is the best packaging for varenicline tartrate tablets.