卡式瓶多剂量重组人干扰素α2b注射液模拟使用的稳定性  

Stability of multi-dose recombinant human interferon α2b injection filled in cassette bottle in simulated application

作　　者：王莹 俞露 杨红育 孙瑞欣 刘玉林 王江林 富锐丽 刘莹 刘琳琳 刘景会 邹勇 WANG Ying;YU Lu;YANG Hong-yu;SUN Rui-xin;LIU Yu-lin;WANG Jiang-lin;FU Ruili;LIU Ying;LIU Lin-lin;LIU Jing-hui;ZOU Yong(Changchun Institue of Biological Products Co.,Ltd.,Changchun 130012,Jilin Province,China)

机构地区：[1]长春生物制品研究所有限责任公司,吉林长春130012

出　　处：《中国生物制品学杂志》2020年第4期410-414,419,共6页Chinese Journal of Biologicals

摘　　要：目的评价卡式瓶多剂量包装重组人干扰素α2b注射液使用过程中的稳定性。方法将3批重组人干扰素α2b注射液装入配套使用的多剂量可重复使用注射笔中,安装胰岛素针头,每天模拟注射过程后分别存放于2~8、(25±2)和(37±2)℃条件下,并分别于0、7、21、35 d,0、3、5、7 d,0、2、4 d取样,依据《中国药典》四部(2015版)和《重组人干扰素α2b注射液制造和检定规程(暂定)》规定,进行外观、可见异物、pH、生物学活性、渗透压、细菌内毒素、间甲酚、无菌检测。结果 3批重组人干扰素α2b注射液模拟使用过程中,于2~8、(25±2)和(37±2)℃分别放置35、7和4 d,外观、可见异物、pH、生物学活性、渗透压、细菌内毒素、间甲酚、无菌检测结果均符合本品相关质量标准规定,且各项检测指标的检测结果均与初始检测结果接近,几乎无变化。结论本品模拟使用过程中即使破坏包装,于2~8、(25±2)和(37±2)℃条件下仍可分别稳定存放至少35、7和4 d。本研究为本品使用过程中的存放条件及相应存放条件下的存放时限确定提供了数据支持。Objective To evaluate the stability of recombinant human interferon(rhIFN) α2 b injection in multi-dose package in cassette bottle during application. Methods Three batches of recombinant human interferon α2 b injection filled in cassette bottles were injected into the multi-dose reusable injection pens,and insulin needles were installed.After the simulated injection process every day,the rhIFNα2 b were stored at 2 ~ 8,(25 ± 2) and(37 ± 2) ℃ respectively. Samples were taken from the IFNα2 b 0,7,21 and 35 d after storage at 2 ~ 8 ℃,0,3,5 and 7 d after storage at(25 ± 2)℃ and 0,2 and 4 d after storage at(37 ± 2)℃,and tested for appearance,visual foreign matters,pH value,biological activity,osmotic pressure,bacterial endotoxin,m-cresol and sterility according to the requirements in Chinese Pharmacopoeia(Vol Ⅳ,2015 edition)and the Requirements for Recombinant Human Interferon(rhIFN)α2 b Injection(draft). Results During the simulated injection,the test results of appearance,visible foreign matter,pH,biological activity,osmotic pressure,bacterial endotoxin,m-cresol and sterility met the relevant requirements after storage at 2 ~8,(25 ± 2)and(37 ± 2)℃ for 35,7 and 4 d respectively,which showed no significant difference with those before storage. Conclusion Even the package is broken during the simulated injection,the rhIFNα2 b may be stably stored for at least 35,7 and 4 d at 2 ~ 8,(25 ± 2)and(37 ± 2)℃ respectively. This study provides a data basis for determining the storage condition during application of rhIFNα2 b and the storage time under the corresponding storage conditions.

关 键 词：重组人干扰素α2b注射液 卡式瓶 多剂量 模拟使用 稳定性 

分 类 号：Q511[生物学—生物化学]