长效重组人促卵泡激素主要功效的对比研究

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(rhFSH-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(rhFSH-CTP) and the reference drug Elonva^® by in vivo pharmacodynamics of young rats.Methods: The in vivo bioactivity was evaluated according to ChP 2010.The pharmacodynamica was studied by superovulation for rhFSH-CTP injection in SD female rats, aged 4-5 weeks, with weight of 70-90 g.Results: The biopotency of the rhFSH-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 rhFSH-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 rhFSH-CTP injection Lot No.20140901 has bioactivity and long-term promotion effect on superovulation, both of which are similar to those of Elonva^®.