为蛋白质药的非注射线路的发展,特别口头的管理,是药的控制版本的主要焦点。到例如酶降级和肠的上皮的穿入障碍未解决的克服的障碍,把微范围用作蛋白质药的搬运人的技术被证明潜在认识到口头的管理。微范围不能仅仅保护蛋白质,这被表明了,而且通过 Peyer 便于穿入和吸收“当尺寸比 10mum 小时, s 修正。因此,这篇论文的目的是与尺寸 【=10 妈妈准备装载蛋白质的微范围。当药模型和钠藻朊作为微范围材料吃了,静电的微滴产生技术与胰岛素和血红素被使用。由减少表面紧张由增加表面活化剂,并且由为冻结答案改变容器和电极的形状改进电场分发喂答案,有平均数的装载蛋白质的微范围缩放更少的 than10 妈妈成功地与 400 妈妈的直径通过针被生产。微范围显示出好球状和狭窄的尺寸分发。尺寸分发 was1.61 的吝啬的标准变化。蛋白质的封装效率是超过 70% 。而且,影响蛋白质的尺寸的因素的意义分析装载了微范围通过直角的实验被执行,它显示出在针尖端之间的那产量电压(U) ,针直径(D) 和距离到显著地影响的冻结答案(三角洲) 的表面微范围的尺寸。最后,统计分析看了那什么时候信心水平,是 alpha=0.05 ,和 alpha=0.1 ,微范围尺寸的信心间隔能是( 6.2545,10.1735 )并且( 6.6022 , 9.8258 )相应地,建议为改进静电的微滴产生技术与尺寸【= 10mum 准备装载蛋白质的微范围有好重覆性和可靠性。
The development of non-injection route for protein drugs, especially oral administration, has been the main focus of controlled release of drugs. To overcome obstacles unsolved such as enzyme degradation and penetration barrier of intestinal epithelium, technologies using microspheres as carrier of protein drugs have been proven potential to realize oral administration. It has been demonstrated that microspheres can not only protect proteins, but also facilitate the penetration and absorption through Peyer's patches when the size is smaller than 10 μm. Therefore, the objective of this paper is to prepare protein-loaded microspheres with size ≤ 10 μm. Electrostatic droplet generation technology was used with insulin and hemoglobin as drug models and sodium alginate as microsphere material. By decreasing the surface tension of feed solution by adding surfactant, and improving electric field distribution by changing the shape of container and electrode for gelation solution, protein-loaded microspheres with mean size less than 10 μm were successfully produced through needle with diameter of 400 μm. The microspheres showed good sphericity and narrow size distribution. The mean standard variance of size distribution was 1.61. The encapsulation efficiency of proteins was over 70%. Moreover, the significance analysis of factors influencing the size of protein loaded microspheres was carried out through orthogonal experiments, which showed that output voltage (U), needle diameter (D) and the distance between needle tips to the surface of gelation solution (8) influenced significantly the size of microspheres. Finally, the statistic analysis showed that when confidence level was α=0.05, and α=0.1, confidence interval of microsphere size can be (6.2545, 10.1735) and (6.6022, 9.8258) correspondingly, suggesting that there is good repeatability and reliability for improving electrostatic droplet generation technology to prepare protein-loaded microspheres with size ≤ 10 μm.