摘要
目的:选取江苏万邦医药科技有限公司与原研厂家生产的精蛋白锌重组赖脯胰岛素混合注射液(25R),测定其临床稳定性。方法:按照万邦笔使用说明书对笔芯内精蛋白锌重组赖脯胰岛素混合注射液(25R)模拟临床注射操作,对初始、中间、取样后笔芯中剩余药液的含量与可溶性重组赖脯胰岛素进行检测,评价其在临床使用中是否稳定和符合相关规定。结果:三批样品各取样点与剩余药液的含量均在产品标示量的90.0%~105.0%范围内,可溶性重组赖脯胰岛素在20.0%~30.0%范围内,RSD(n=6)均在2.0%以内,符合相关规定。结论:患者在临床使用中严格依据笔式注射器及笔芯使用说明书进行操作,精蛋白锌重组赖脯胰岛素混合注射液(25R)笔芯内重组赖脯胰岛素含量与可溶性重组赖脯胰岛素均未发生显著变化,稳定性良好。
Objective： To evaluate the content of the cartridges at the initial and mid-phase, and the end-point remnant medicine of mixed protamine zinc recombinant human insulin lispro injections（25 R）, both domestic and imported, according to the product instructions of Wanbang pen in a simulated clinical environment for analyzing their stability. Methods： Simulated clinical operation, the samples were tested at the specified time points.Results： The content of all the samples at various time points were within 90.0% ~ 105.0% of the listed valuesand 20.0% ~ 30.0% for the soluble recombinant insulin human lispro. RSD was within 2.0%（n=6）. Conclusion： The content of mixed protamine zinc recombinant human insulin lispro injection（25 R） does not show significant change, thus a desirable glycemic control can be expected if the product instructions are strictly followed during clinical applications.
作者
梅丽
蒋玲
杨桦
栗凤娟
Mei Li;JiangLing;Yang Ye;Lifeng-juan(WanbangPharma Technology Co.,Ltd.Jiangsu Xuzhou 221004)
出处
《生物化工》
2018年第3期78-80,共3页
Biological Chemical Engineering
