重组人生长激素水针剂与冻干剂对去垂体大鼠的药效和生物活性比对研究

目的: 评价一个新生物类似药重组人生长激素(rhGH)水针剂的体内生物活性和促动物机体生长的功效,并与参照药即已上市的rhGH冻干粉针剂比较其相似性. 方法: 生物活性测定按中国药典2010年版二部附录生长激素生物测定法即去除脑垂体大鼠体重增重法进行;功效试验以去除脑垂体大鼠GH缺乏为动物模型,比对研究rhGH水针剂与rhGH国家标准品和参照药(粉针剂)在促动物生长指标方面的差异. 结果: 试验结果证明rhGH水针剂与参照药rhGH冻干粉针剂生物活性相似.与模型组相比,rhGH水针剂与粉针剂各剂量组体重、尾长、胫骨骨骺板宽度、肝脏重量等生长指标均有显著增加(P <0.05),并有量效关系,2种剂型间差异无显著性意义(P> 0.05). 结论: 经比对试验研究,证明某企业的rhGH水针剂与参照药在药效和生物活性方面具有相似性.

Objective: To evaluate the in vivo bioactivity and efficacy on growth promotion of a new biosimilar liquid formulation of recombinant human growth hormone (rhGH),and compare it with the reference drug for the similarity i.e.,the currently marketed freeze-dried formulation of rhGH in hypophysectomized (Hpx) young rats. Methods: The in vivo bioactivity was evaluated according to the ChP 2010.Vol Ⅱ,namely,the bioassay for growth hormone by body weight gain in Hpx young rats.The differences in growth promotion indexes were compared between the liquid formulation of rhGH,the national standard and the lyophilized formulation of rhGH taking Hpx young rats with GH deficiency as the experimental model. Results: The experiment results demonstrated that the liquid formulation of rhGH and the reference drug-lyophilized formulation of rhGH were similar in in vivo bioactivity.The growth measurements (body weight,tibial epiphysis width,tail length and liver weight) increased for groups of Hpx young rats using liquid and lyophilized formulations of rhGH compared with the model group (P <0.05),and the dose-dependent increase was significant.There was no significant difference between the two formulations (P> 0.05). Conclusion: This comparative experiment demonstrated that the liquid formulation of rhGH from the pharmaceutical biotech company shows similarity with the reference drug-lyophilized formulation of rhGH in efficacy and in vivo bioactivity.