两种不同形状内包装材料生产的人血白蛋白质量可比性研究  

Comparability Study of Human Albumin Produced with Different Shapes of Internal Packaging Materials

作　　者：赵书艺 杨灵通 才辉 任和 张大满 勾洋梅 韩祥东 杨晓东 ZHAO Shuyi;YANG Lingtong;CAI Hui;REN He;ZHANG Daman;GOU Yangmei;HAN Xiangdong;YANG Xiaodong(Sinopharm Group Lanzhou Biopharmaceutical Co.,Ltd.,Lanzhou 730046,China)

机构地区：[1]国药集团兰州生物制药有限公司,兰州730046

出　　处：《包装工程》2024年第7期38-44,共7页Packaging Engineering

基　　金：甘肃省青年科技基金(21JR7RA322)。

摘　　要：目的比较2种不同形状的药包材包装的人血白蛋白质量,为制剂企业选择可满足药品生产和使用要求的药包材提供依据,保证药品质量,满足临床需求和使用安全。方法对2种药包材包装的人血白蛋白在(25±2)℃进行6个月的稳定性考察,观察不同时间点的产品质量指标变化,并对2种药包材包装的人血白蛋白密封性进行分析。结果加速稳定性考察中,2种内包材生产的人血白蛋白在各考察时间点的质量指标均符合《中华人民共和国药典》(2020年版三部),关键质量指标趋势变化一致。同时,小规格药包材生产的人血白蛋白pH值、纯度、铝残留量的稳定性更好。2种药包材生产的人血白蛋白经密封性测定均未发现泄漏。结论2种不同形状的内包装材料生产的人血白蛋白质量均符合要求,且密封性良好,能保障药品的质量安全。同时,小规格药包材包装的人血白蛋白质量指标稳定性更好。The work aims to compare the quality of human albumin in two materials of different shapes,and provide a basis for preparation enterprises to choose pharmaceutical packaging materials that can meet the requirements of drug manufacturing and use,so as to ensure the quality of drugs,and meet clinical needs and use safety.The stability of human albumin in the two packages was investigated at(25±2)℃for 6 months to observe the change of product quality index at different time points,and analyze the sealing of human albumin in the two internal packaging materials.The quality indexes at each time point of the inspection all met the"Pharmacopoeia of the People's Republic of China"(2020 edition),and the trends of key quality indicators were consistent.At the same time,small pharmaceutical packaging material of human albumin had better stability in pH,purity and aluminum residue.No leakage of human albumin was detected in two packages.Two internal packaging materials of different shapes have no significant effect on the quality of human albumin.They have good sealing,which can guarantee the quality and safety of drugs.At the same time,small specification pharmaceutical packaging material of human albumin has better stability.

关 键 词：人血白蛋白 药包材 加速稳定性考察 相容性 密封性 

分 类 号：TB484[一般工业技术—包装工程] TG174.484[金属学及工艺—金属表面处理]