首批重组人血白蛋白蛋白质含量RS2国家标准品的研制  

Development of the First Batch of National Protein Content Standard RS2 for Recombinant Human Albumin

作　　者：王敏力[1] 王弢 李炎 邵泓 李镭 范加金 马力 李宝泉 罗清 徐苗[1] 侯继锋[1] WANG Min-li;WANG Tao;LI Yan;SHAO Hong;LI Lei;FAN Jia-jin;MA Li;LI Bao-quan;LUO Qing;XU Miao;HOU Ji-feng(National Institutes for Food and Drug Control,WHO Collaboration Center for Standardization and Evaluation of Biologicals,Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products,Beijing 100050,China;Lanzhou Institute of Biological Products Co.,Ltd.,Lanzhou 730046,China;Sichuan Institute For Food and Drug Control,Chengdu 611731,China;Shanghai Institute for Food and Drug Control,Shanghai 201203,China;BioRay Pharmaceutical Co.,Ltd.,Taizhou 318000,China;China Biologic Products Holdings,Inc.,Taian 271000,China;Hualan Biological Engineering,Inc.,Xingxiang 453003,China;Innovent Biologics,Inc.,Suzhou 215123,China;Sunshine Guojian Pharmacutical(Shanghai)Co.,Ltd.,Shanghai 201203,China)

机构地区：[1]中国食品药品检定研究院,WHO生物制品标准化和评价合作中心,卫生部生物技术产品检定方法及标准化重点实验室,北京100050 [2]兰州生物制品研究所有限责任公司,兰州730046 [3]四川省食品药品检验检测院,成都611731 [4]上海市食品药品检验研究院,上海201203 [5]浙江博锐生物制药有限公司,浙江台州318000 [6]山东泰邦生物制品有限公司,山东泰安271000 [7]华兰生物工程股份有限公司,河南新乡453003 [8]信达生物制药(苏州)有限公司,江苏苏州215123 [9]三生国健药业(上海)股份有限公司,上海201203

出　　处：《中国药学杂志》2022年第15期1283-1286,共4页Chinese Pharmaceutical Journal

基　　金：国家科技重大专项项目课题资助:创新生物技术药评价及标准化关键技术研究(2018ZX09101001);重组人血白蛋白质量控制关键技术和标准研究(2018ZX09301004)。

摘　　要：目的研制一种重组人血白蛋白蛋白质含量RS2国家标准品,用于重组人血白蛋白等产品的蛋白质含量测定。方法选取重组人血白蛋白产品作为原料,经质量浓度9 g·LNaCl溶液稀释后除菌过滤分装。在8家实验室按经确认和验证的方法进行协作标定并开展稳定性监测。结果8家实验室采用包括高效液相色谱法(HPLC)、福林酚法(Lowry)、紫外测定法(UV)、2,2′-联喹啉-4,4′-二羧酸法(BCA)等测定本批标准品,蛋白质含量实验室间均值为1961(Min 1904,Max 2063)μg·mL^(-1),95%置信区间(1917,2016)μg·mL^(-1);实验室间标定结果均值标准差52.89,标准误18.70,相对标准偏差(RSD)为2.70%。2~8℃持续对该标准品进行稳定性监测19个月,蛋白质含量未发生趋势性变化,建议本品按2~8℃保存和运输。结论重组人血白蛋白蛋白质含量RS2国家标准品符合相关规定,可以发放用于重组人血白蛋白相关的质量控制。OBJECTIVE To develop a national standard for determination of protein content of recombinant human albumin.METHODS The recombinant human albumin product was selected as raw material,then diluted with 9 g·LNaCl solution and sterilized by filtration.Collaborative calibration and stability monitoring were carried out in eight laboratories according to the confirmed and verified methods.RESULTS Eight laboratories used HPLC method,Lowry method,UV method and BCA method to determine the protein content of the national reference standard 2(RS2)for recombinant human albumin.The inter-laboratory mean value was 1961μg·mL^(-1)(range 1904-2063μg·mL^(-1),95%CI 1917-2006μg·mL^(-1)).The mean standard deviation of calibration results between laboratories was 52.89,the standard error was 18.70,and the inter-laboratory relative standard deviation(RSD)was 2.70%.The stability of the standard sample at 2-8℃was monitored continuously for 19 m and there was no trend of change in protein content.It is suggested that the standard would be stored and transported at 2-8℃.CONCLUSION The national protein content standard RS2 for recombinant human albumin meets the relevant standards,which can be used for the quality control of recombinant human albumin.

关 键 词：重组人血白蛋白 蛋白质含量测定 国家标准品 重组生物药物 

分 类 号：R965[医药卫生—药理学]