重组人促卵泡激素体内生物活性和对幼龄大鼠超排卵作用  

In vivo bioactivity of recombinant human follicle-stimulating hormone and its effect on superovulation in immature rats

作　　者：程速远[1] 王俊玲 李心欣[1] 吴彦卓 梁成罡[1] 李湛军[1] 

机构地区：[1]中国食品药品检定研究院,北京100050 [2]北京双鹭药业股份有限公司,北京100049

出　　处：《中国新药杂志》2015年第17期1963-1967,共5页Chinese Journal of New Drugs

基　　金：国家"重大新药创制"科技重大专项(2012ZX09304010)

摘　　要：目的：评价新生物类似药重组人促卵泡激素（recombinant human follicle-stimulating hormone,rh FSH）的体内生物活性和药效学超排卵作用,并与参照药即已上市的果纳芬（Gonal-F（R））比较其相似性。方法：生物活性测定按《中华人民共和国药典》（Ch P）雌幼龄大鼠卵巢增重法进行;药效学研究为以未成年4~5周龄,体重60~80 g的SD雌性大鼠研究rh FSH超排卵作用,实验结束后检测超排卵效果。结果：rh FSH该批冻干制剂的生物效价为85 IU/瓶,与参照药果纳芬（Gonal-F（R））相似;其超排卵作用比阴性对照组（空白组）卵巢系数、卵子数、组织病理学等指标显著增大（P〈0.01）,与果纳芬间的差异无显著性意义（P〉0.05）。结论：新生物类似药rh FSH批号20140502的制剂,具有较高生物活性和超排卵的作用,与参照药果纳芬（Gonal-F（R））活性和药效相似。Objective： To evaluate the in vivo bioactivity and pharmacodynamic of recombinant human follicle-stimulating hormone（ rh FSH） on superovulation in immature rats and compare it with the reference drug GonalF（R）. Methods： The in vivo bioactivity of rh FSH lyophilized formulation（ lot 20140502） was investigated by immature female rat ovary weight gain method according to the Ch P. SD female rats were superovulated with rh FSH preparations. Results： The biopotency of rh FSH lyophilized formulation was 85 IU·vial- 1,similar to Gonal-F（R）. The effect of rh FSH lyophilized formulation on superovulation as determined by ovarian factor,number of ovums and histopathology indicators were significantly increased compared with negative control group（ P 0. 01）,and not significantly different compared with Gonal-F（R）. Conclusion： The investigated batch of new biosimilar drug rh FSH lyophilized formulation（ lot 20140502） has similar bioactivity and superovulation effect with Gonal-F（R）.

关 键 词：重组人促卵泡激素 生物类似药 体内生物活性 超排卵作用 药效学 

分 类 号：R977.1[医药卫生—药品]