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目的对前列地尔注射液与所使用玻璃包材进行研究,评价包材是否适用于本品包装。方法通过电镜检查所用包材在稳定性考察过程中是否有脱片现象,通过电感耦合及原子吸收方法检测稳定性样品溶液中离子变化情况,评价是否有离子迁移。结果 6个月的稳定性考察(加速及长期)结果表明玻璃包材没有脱片现象、玻璃中的离子没有向药液中迁移。结论本品包材相容性良好,可用于本品包装。
OBJECTIVE To study the alprostadil injection and the glass packaging material used to evaluate whether the packaging material is suitable for packaging this product. Methods Electron microscopy was used to examine whether the packing material used during the investigation of stability was delaminated. The change of ions in the sample solution was detected by inductive coupling and atomic absorption to evaluate whether there was ion migration. RESULTS The 6-month stability study (accelerated and long-term) results showed that the glass-coated material did not delaminate and the ions in the glass did not migrate into the liquid. Conclusion This package material good compatibility, can be used for packaging this product.