利用Nb2-11细胞建立PEG化重组人生长激素生物学活性测定方法  

A novel bioassay to assess bioactivity of PEG-rhGH using Nb2-11 cells

作　　者：张孝明 黄盈 王绿音 李懿 李晶[1] 梁成罡[1] ZHANG Xiao-ming;HUANG Ying;WANG Lü-yin;LI Yi;LI Jing;LIANG Cheng-gang(National Institutes for Food and Drug Control,NHC Key Laboratory of Research on Quality and Standardization of Biotech Products,Beijing 102629,China;China Pharmaceutical University,Nanjing 211198,China)

机构地区：[1]中国食品药品检定研究院,国家卫生健康委员会生物技术产品检定方法及其标准化重点实验室,北京102629 [2]中国药科大学,江苏南京211198

出　　处：《药学学报》2023年第3期773-778,共6页Acta Pharmaceutica Sinica

基　　金：中国食品药品检定研究院中青年发展研究基金(2022A1)。

摘　　要：本研究利用Nb2-11细胞,通过实验条件参数优化和方法学验证,成功建立了测定聚乙二醇化重组人生长激素(PEG-rhGH)体外生物学活性分析方法,并用该方法开展了PEG-rhGH注射液相对效价检测。研究表明,PEGrhGH与Nb2-11细胞增殖存在量效关系且符合四参数模型,用该方法检测PEG-rhGH的生物学活性准确度高、精密度好。以PEG-rhGH参比品为对照,对6批PEG-rhGH注射液进行相对效价测定,所得曲线线性、回归性和平行性均通过统计学检验,相对效价在95%~105%。本研究建立的PEG-rhGH生物学活性检测方法,可用于PEG-rhGH产品的质量控制。In this study,we established a novel bioassay to determine the activity of polyethylene glycolated recombinant human growth hormone(PEG-rhGH)using Nb2-11 cells.We performed experimental condition optimization and methodological verification,and then detected the relative potency of PEG-rhGH products using this method.We demonstrated that the bioactivity of PEG-rhGH in promoting Nb2-11 cell proliferation displays a doseresponse relationship,which conformed to the four-parameter model.Using PEG-rhGH reference as a control,we analyzed the relative potency of six batches of PEG-rhGH products,as well as linearity,regression and parallelism of the obtained curves.The relative potency of six batches of PEG-rhGH products was 95%to 105%.These results implied that the new bioassay established may be employed in quality control of PEG-rhGH products.

关 键 词：聚乙二醇化重组人生长激素 生物学活性 质量控制 方法学验证 细胞增殖法 

分 类 号：R917[医药卫生—药物分析学]