重组人促卵泡激素质量控制中理化测定代替生物测定简介  

Physicochemical methods alternative for bioassays for recombinant human follicle-stimulating hormone in quality control

作　　者：李湛军[1] 梁成罡[1] 杨化新[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《药物分析杂志》2014年第9期1524-1529,共6页Chinese Journal of Pharmaceutical Analysis

基　　金：十二五重大新药创制-创新药物研究开发技术平台建设(No.2012ZX09304010)

摘　　要：本文综述重组人促卵泡激素(rhFSH)质量控制中的生物测定的作用与局限性。对长期批次间一致的rhFSH产品,理化测定将代替生物效价的测定,但在研发阶段仍需选择生物测定。Limitations and role of the bioassay for recombinant human folliclestimulating hormone（ rhFSH） were reviewed. It is clarified that the physicochemical determination will substitute the potency determination for rhFSH preparations which have long term batchtobatch consistency while bioassay would still be chosen in the research and development stage.

关 键 词：重组人促卵泡激素 体内生物测定 理化方法 替代 比活性 批次间一致性 

分 类 号：R917[医药卫生—药物分析学]