重组白细胞抑制因子和水蛭肽嵌合蛋白质量标准研究  

Study on specifications for quality control of recombinant neutrphil inhibitory factor and hirulog hybrid

作　　者：辛中帅[1] 李克坚[1] 杨化新[1] 梁成罡[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《中国新药杂志》2008年第21期1865-1868,共4页Chinese Journal of New Drugs

摘　　要：目的:建立重组白细胞抑制因子和水蛭肽嵌合蛋白(TNHH)的质控方法和质量标准。方法:采用抗凝血酶活性试验和抗白细胞黏附试验测定活性;通过胰蛋白酶消化分析该蛋白还原型肽图;利用RP-HPLC法和SEC-HPLC法分别测定有关物质和高分子蛋白质含量;其余检测项目均按《中华人民共和国药典》2005版三部相关规定进行。结果:用建立的方法分别对一批TNHH原液和成品进行了检定,各项指标均符合《人用重组DNA制品质量控制技术指导原则》和现版《中华人民共和国药典》的要求。结论:建立的质控方法可有效地控制TNHH产品质量,并可用于TNHH原液及成品的常规检定。Objective：To establish methods and specifications for quality control of recombinant neutrphil inhibitory factor and hirulog hybrid（TNHH）.Methods： Biological activity of TNHH was determined by anti-thrombin assay and anti-leucocyte cell adhesion assay.Reduced peptide mapping was analyzed by trypsin digestion and following RP-HPLC.Related compounds and high molecular weight proteins were analyzed by RP-HPLC and SEC-HPLC.Other tests were performed according to the requirements of Chinese Pharmacopoeia.Results：The established methods for the quality control of TNHH were used for both TNHH bulk and final product.The results of all tests complied with Chinese Pharmacopoeia and other national guidelines.Conclusion：The established methods and specifications can be applied to control the quality of TNHH safely and efficiently and can be used for routine quality control of TNHH.

关 键 词：白细胞抑制因子 水蛭肽 质量标准 

分 类 号：R972[医药卫生—药品]