【摘要】：目的:評價新生物類似藥重組人促卵泡激素(recombinant human follicle-stimulating hormone,rh FSH)的體內(nèi)生物活性和藥效學超排卵作用,并與參照藥即已上市的果納芬(Gonal-F汶)比較其相似性。方法:生物活性測定按《中華人民共和國藥典》(Ch P)雌幼齡大鼠卵巢增重法進行;藥效學研究為以未成年4~5周齡,體重60~80 g的SD雌性大鼠研究rh FSH超排卵作用,實驗結(jié)束后檢測超排卵效果。結(jié)果:rh FSH該批凍干制劑的生物效價為85 IU/瓶,與參照藥果納芬(Gonal-F汶)相似;其超排卵作用比陰性對照組(空白組)卵巢系數(shù)、卵子數(shù)、組織病理學等指標顯著增大(P0.01),與果納芬間的差異無顯著性意義(P0.05)。結(jié)論:新生物類似藥rh FSH批號20140502的制劑,具有較高生物活性和超排卵的作用,與參照藥果納芬(Gonal-F汶)活性和藥效相似。
[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.
【作者單位】： 中國食品藥品檢定研究院;北京雙鷺藥業(yè)股份有限公司;
【基金】：國家“重大新藥創(chuàng)制”科技重大專項(2012ZX09304010)
【分類號】：R965
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本文編號：2363367