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
发布时间：2018-11-28 15:53
【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汶)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汶)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(P0.01),与果纳芬间的差异无显著性意义(P0.05)。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汶)活性和药效相似。
[Abstract]:Aim: to evaluate the in vivo bioactivity and pharmacodynamics of recombinant human follicle stimulating hormone (recombinant human follicle-stimulating hormone,rh FSH), a new biological analogue, and to compare its similarity with that of Gonal-F. Methods: the assay of biological activity was carried out according to the method of ovarian weight gain of (Ch P) female and young rats. The pharmacodynamic study was conducted to study the effect of rh FSH superovulation on female SD rats aged 4 ~ 5 weeks and weighing 60 ~ 80g. The effects of superovulation were detected after the experiment. Results the bioactivity of: rh FSH freeze-dried preparations was 85 IU/ bottles, which was similar to that of Gonal-F. Compared with the negative control group, the ovarian coefficient, egg number, histopathology and other indexes of hyperovulation were significantly increased (P0.01), and there was no significant difference between them (P0.05). Conclusion: the preparation of rh FSH batch 20140502 has higher biological activity and superovulation, and is similar to the control drug Gonal-F.
【作者单位】： 中国食品药品检定研究院;北京双鹭药业股份有限公司;
【基金】：国家“重大新药创制”科技重大专项(2012ZX09304010)
【分类号】：R965
，
本文编号：2363367
[Abstract]:Aim: to evaluate the in vivo bioactivity and pharmacodynamics of recombinant human follicle stimulating hormone (recombinant human follicle-stimulating hormone,rh FSH), a new biological analogue, and to compare its similarity with that of Gonal-F. Methods: the assay of biological activity was carried out according to the method of ovarian weight gain of (Ch P) female and young rats. The pharmacodynamic study was conducted to study the effect of rh FSH superovulation on female SD rats aged 4 ~ 5 weeks and weighing 60 ~ 80g. The effects of superovulation were detected after the experiment. Results the bioactivity of: rh FSH freeze-dried preparations was 85 IU/ bottles, which was similar to that of Gonal-F. Compared with the negative control group, the ovarian coefficient, egg number, histopathology and other indexes of hyperovulation were significantly increased (P0.01), and there was no significant difference between them (P0.05). Conclusion: the preparation of rh FSH batch 20140502 has higher biological activity and superovulation, and is similar to the control drug Gonal-F.
【作者单位】： 中国食品药品检定研究院;北京双鹭药业股份有限公司;
【基金】：国家“重大新药创制”科技重大专项(2012ZX09304010)
【分类号】：R965
，
本文编号：2363367
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