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目的:研制神经生长因子(nerve growth factor,NGF)复合缓释制剂,探讨其作为补充外源性NGF制剂的可行性。方法:采用NGF微球,与生物纤维蛋白胶混合形成NGF复合缓释制剂,分别进行体外、体内实验。体外实验包括药物释放曲线和释放药物的活性鉴定;体内实验为18只雄性W istar大鼠,根据修改缺损材料不同,随机分成3组(n=6):去细胞异体神经移植+NGF复合缓释制剂组(A组);化学去细胞异体神经移植组(B组):去细胞异体神经移植+纤维蛋白胶组(C组),术后2周测量神经轴突生长距离。结果:体外实验证明,NGF复合缓释制剂可持续释放NGF达60d以上,释出的NGF可促进鸡胚背根神经节神经纤维突起生长,具有较强的生物学活性。术后2周,测量再生神经生长距离分别为:A组(7.46±1.75)mm,B组(4.62±1.06)mm,C组为(4.36±1.20)mm,A组明显高于B、C组(P<0.05)。结论:制备的NGF复合缓释制剂,可长期释放NGF,并具有生物活性,可作为NGF良好的外源性补充制剂。
OBJECTIVE: To develop a composite sustained-release preparation of nerve growth factor (NGF) and explore its feasibility as a supplement of exogenous NGF. Methods: NGF microspheres were mixed with bio-fibrin glue to form NGF composite sustained-release preparations, respectively, in vitro and in vivo experiments. In vitro experiments including the drug release curve and the release of drug activity identification; In vivo experiments were 18 male Wistar rats, according to modify the different defect materials were randomly divided into three groups (n = 6): acellular nerve allograft + NGF composite sustained release (Group A), chemical acellular nerve allograft (group B): acellular nerve allograft + fibrin glue group (group C). The axon growth distance was measured 2 weeks after operation. Results: In vitro experiments showed that NGF sustained release NGF for more than 60 days, the release of NGF can promote chick embryo dorsal root ganglion neurite outgrowth growth, with strong biological activity. The distance of regenerative nerve growth was measured at 2 weeks after operation in group A (7.46 ± 1.75) mm, in group B (4.62 ± 1.06) mm and in group C (4.36 ± 1.20) mm respectively, significantly higher in group A than in group B and C (P <0.05). CONCLUSION: The prepared NGF sustained-release preparation can release NGF for a long time and has biological activity, and can be used as a good exogenous supplement preparation of NGF.