头孢呋辛酯分散片包装材料和药物相容性研究

Compatibility of Cefuroxime Axetil Dispersible Tablets and the Direct Package Materials

目的:研究头孢呋辛酯分散片与包装材料的相容性。方法:采用聚氯乙烯/聚偏二氯乙烯固体药用复合硬片(PVC/PVDC硬片)、聚氯乙烯固体药用硬片(PVC硬片)作为药品的包装材料,高效液相色谱法检测包装前后样品在影响因素条件下有关物质种类和含量的变化情况。结果:PVDC材料包装的头孢呋辛酯分散片在高温条件下有关物质含量远高于PVC硬片包装样品。结论:PVDC材料与头孢呋辛酯在高温条件下有相容性问题。

Objective：To study the compatibility of cefuroxime axetil dispersible tablets and the direct package materials.Method： Aluminum foil on PVC / PVDC hard sheet and PVC hard sheet was respectively used as the direct contact material for the tablets, and an HPLC method was used for the determination of the type and content changes in the related substances under the different influencing factors.Result：The content changes in the related substances with PVC/PVDC hard aluminum composite sheet were much significant than those with PVC hard aluminum composite sheet under the high temperature conditions.Conclusion：PVDC as the direct package material is unsuitable for cefuroxime axetil dispersible tablets.