人免疫球蛋白内包装材料相容性研究

Primary packaging material compatibility study for human immunoglobulin

目的 研究人免疫球蛋白制品与直接接接触的硼硅玻璃相容性，为选用合适的内包装材料（内包材）提供依据。方法 分别选用不同厂家提供的中性硼硅玻璃瓶，进行产品相容性试验，比较内包材对产品质量的影响。结果 随着产品与内包材表面接触时间的增长，内包材迁移至产品的各种微量元素和溶出物均未超过国家限值；产品的各项指标均符合标准，其中存储24个月的产品pH值为6.6～6.8，IgG单体与二聚体含量和〉95%。结论 中性硼硅玻璃瓶适用于人免疫球蛋白产品的储存，不会影响产品质量。

Objective To study the compatibility of the immunoglobulin products and borosilicate glass in direct contact with products, providing basis for for appropriate primacy packaging material selection. Methods Neutral borosilicate glass bottles provided by different manufacturers were chosen to carry out product compatibility tests. Results As contact time with products increased, trace elements and substances dissolved from primary packaging materials migrating into products did not exceed regulation limits.Product qualities met requirements. In products stored for 24 months,the pH was 6.6-6.8,and monomer plus dimer IgG was 〉95%. Conclusion The neutral borosilicate glass bottles are suitable for the storage of human immunoglobulin products,and do not affect product quality.