【摘要】 目的研制重组人骨形态发生蛋白-2(rhBMP-2)膜片并对其稳定性进行研究,最终提供用于临床试验的合格样品。方法1.采用医用胶原蛋白海绵作为辅料,与rhBMP-2悬液复合,制作成膜片,钴60消毒后测活并送检各项指标。2.采用血清钙试剂盒的方法,通过检测不同条件处理后的rhBMP-2样品的活性变化来反映样品的生物稳定性。结果rhBMP-2膜片生物活性良好,经中国药品生物制品检定所检验各项指标符合要求;在4℃放置两年,活性依然保持良好;在室温放置6个月,活性略有降低;而在37℃条件下,放置1个月活性明显降低,但放置半年与放置1个月活性差别不大。结论所研制的rhBMP-2膜片,稳定性良好,符合临床试验的各项指标。更多还原

【Abstract】 Purpose To prepare the befitting form of recombinant human bone morphogenetic protein-2(rhBMP-2)for clinical trial and to observe the stability of the products.Methods 1.The composite film was prepared by dropping suspended liquid of rhBMP-2 samples onto the collagen sponge which is used for assistive supplement in clinic.After sterilization with cobalt 60,the products were tested for biological activity and other medical indexes.2.Using serum calcium test kit,the stability of rhBMP-2 products were investigated by measuring the biological activity of the samples treated under different conditions.Results The rhBMP-2 composite with collagen film showed a satisfying biological activity.And the quality of the composite patch conformed to the clinical demands tested by National Institute for the Control of Pharmaceutical and Biological Products.The results showed that after 2 years storage at 4℃,the biological activity of rhBMP-2 was retained good.The biological activity showed a slight decrease when the sample was placed at room temperature for 6 months,compared to a marked decrease at 37℃ for 1 month.But the difference is inconspicuous between 1 month treatment and 6 month treatment under 37℃ condition.Conclusion The prepared composite film of rhBMP-2 and collagen sponge conforms to the clinical demands and is stable.It can be used in the clinical trial.更多还原