超滤膜静态吸附蛋白方法的不确定度分析  

Uncertainty analysis of the method of static adsorption of protein by ultrafiltration membrane

作　　者：郭秋兰 陈顺权 王建明 谢绍业 GUO Qiulan;CHEN Shunquan;WANG Jianming;XIE Shaoye(Guangzhou Institute of Advanced Technology,Guanghzou 510000,China)

机构地区：[1]广州先进技术研究所,广东广州510000

出　　处：《中国测试》2024年第S2期94-98,共5页China Measurement & Test

基　　金：广东省基础与应用基础研究计划(202201011763);广东省重点领域研发计划(2023A1111030001)

摘　　要：超滤膜的蛋白吸附是生物制药中产生膜污染的重要原因,其检测结果可以反映超滤膜抗污染的性能。通过测试浸泡蛋白的浓度、料液比、浸泡时间和温度等不同检测条件下膜蛋白吸附量,建立了超滤膜静态吸附蛋白测试方法,分析最优的测试条件为浸泡温度35℃,浸泡牛血清白蛋白浓度为500 mg/L,浸泡时间8 h,料液比为1:2,并对该方法进行不确定评估。结果表明:该方法的各项指标较好,检出限5.28μg/cm^(2),定量限为17.6μg/cm^(2),蛋白检测标准曲线相关系数r^(2)大于0.999;对该方法进行不确定评估,当包含因子k=2时,置信水平为95%,扩展不确定度为6.4μg/cm^(2);浸泡前后BSA浓度的测试是测试结果主要的不确定度来源。The protein adsorption of ultrafiltration membrane is an important cause of membrane fouling in biopharmaceuticals,and its detection results can reflect the anti-fouling performance of ultrafiltration membrane.A test method for static adsorption protein of ultrafiltration membrane was established,and the adsorption capacity of membrane protein under different detection conditions such as soaking protein concentration,solid-liquid ratio,soaking time and temperature was tested.The optimal test conditions for analysis were soaking temperature of 35℃,soaking bovine serum albumin concentration of 500 mg/L,soaking time of 8h,and solid-liquid ratio of 1:2,and the method was evaluated with uncertainty.The results showed that the detection limit was 5.28μg/cm^(2),the quantitation limit was 17.6μg/cm^(2),and the correlation coefficient r^(2) of the standard curve of protein detection was greater than 0.999.When the factor k=2 is included,the confidence level is 95%and the extended uncertainty is 6.4μg/cm^(2).The measurement of BSA concentration before and after immersion is the main source of uncertainty in the test results.

关 键 词：超滤膜 蛋白吸附 牛血清白蛋白 不确定度 

分 类 号：TQ464[化学工程—制药化工] TQ028.8