长效重组人促卵泡激素主要功效的对比研究  

Comparative study on main effects of long-acting recombinant human follicle-stimulating hormone

作　　者：李湛军[1] 王俊玲 李心欣[1] 吴彦卓 梁成罡[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：《药物分析杂志》2016年第3期432-437,共6页Chinese Journal of Pharmaceutical Analysis

基　　金：国家课题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：目的：评价并比较生物类似药候选药长效重组人促卵泡激素（rh FSH-CTP）与参照药Elonva的功能差异,即对幼龄大鼠体内主要药效学作用的相似性。方法：生物活性测定按中国药典方法进行;药效学研究以未成年4-5周龄,体重70-90 g的SD雌性大鼠研究其超排卵作用。结果：rhFSH-CTP注射液的生物效价为453 IU·支-1,与参照药Elonva体内活性相当,两者差异很小;其超排卵作用相比于阴性对照组（空白组）卵巢系数、卵子数、组织病理学总评分等指标显著增大（p〈0.05）,大鼠血清激素水平即雌二醇（E2）、黄体激素（LH）、促卵泡激素（FSH）、孕酮（P）等都有不同程度增加,尤其E2增加显著（p〈0.05）;各指标与Elonva间的差异无显著性意义（p〉0.05）。结论：生物类似药候选药rhFSH-CTP批号20140901的制剂,具有生物活性和促进卵泡发育成熟超排卵的长效作用,与参照品Elonva活性和药效相似。Objective：To evaluate and compare the functional differences and similarity of the candidate biosimilar long-acting recombinant human follicle-stimulating hormone（rh FSH-CTP）and the reference drug Elonva by in vivo pharmacodynamics of young rats.Methods： The in vivo bioactivity was evaluated according to Ch P 2010.The pharmacodynamica was studied by superovulation for rh FSH-CTP injection in SD female rats,aged 4-5 weeks,with weight of 70-90 g.Results： The biopotency of the rh FSH-CTP injection was 453 IU·Vial-1,similar to the in vivo bioactivity of the reference drug Elonva and the difference was very small.The results of superovulation of the rh FSH-CTP injection including the coefficient of ovarian,number of oocytes,histopathology score levels in comparison with the negative control group were significantly increased（p〈0.05）.The serum hormone levels in rats,namely estradiol（E2）,luteinizing hormone（LH）,follicle-stimulating hormone（FSH） and progesterone（P）,all increased to different degrees,especially E2 which significantly increased（p〈0.05）.All indicators showed no significant difference with Elonva（p〈0.05）.Conclusion： The candidate biosimilar rh FSH-CTP injection Lot No.20140901 has bioactivity and long-term promotion effect on superovulation,both of which are similar to those of Elonva.

关 键 词：生物类似药 候选药 长效重组人促卵泡激素 人绒毛膜促性腺激素 β亚基C-末端肽融合蛋白 体内生物活性 超排卵作用 药效学 

分 类 号：R917[医药卫生—药物分析学]