论著

人免疫球蛋白内包材相容性研究

  • 陈蓓 张金云
展开
  • 200051 上海生物制品研究所有限责任公司血液制剂室(陈蓓);315033 宁波正力药品包装有限公司工艺研发部(张金云)

网络出版日期: 2025-08-16

基金资助

null

Primary packaging material compatibility study for human immunoglobulin

Expand
  • *Division of Blood Products, Shanghai Institute of Biological Products Co., Ltd., Shanghai 200051, China

Online published: 2025-08-16

摘要

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。

本文引用格式

陈蓓 张金云 . 人免疫球蛋白内包材相容性研究[J]. 国际生物制品学杂志, 2017 , 40(5) : 232 -236 . DOI: 10.3760/cma.j.issn.1673-4211.2017.05.006

Abstract

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.

参考文献

null
文章导航

/