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目的设计制备一种可用于胰岛素口服给药的新型纳米骨架系统,并进行可行性评价。方法以微粉硅胶为骨架吸附胰岛素,再用聚丙烯酸树脂(EUD)进行包衣,制备了具有纳米骨架结构的胰岛素口服固体给药系统,并对处方比例进行了优化;测定了给药系统的粒径和分布;通过体外酶降解实验考察了给药系统对胰岛素的保护作用;通过正常大鼠腹腔糖耐量实验(IPGTT)观察了给药系统的降血糖作用。结果胰岛素口服纳米骨架给药系统的平均粒径为(466±111)μm;该给药系统能有效减缓胰岛素被肠道消化酶降解的速度;IPGTT实验证实,此给药系统具有明显的降血糖效果(P<0.01)。结论本实验设计和制备的纳米骨架给药系统具有增加胰岛素等多肽类药物口服吸收的作用。
Objective To design and prepare a novel nanostructure system which can be used for the oral administration of insulin and to evaluate its feasibility. Methods Microporous silica gel was used to absorb insulin and then coated with polyacrylic acid resin (EUD). An insulin oral solid delivery system with nanostructure was prepared and the prescription ratio was optimized. Diameter and distribution. The protective effect of the drug delivery system on insulin was investigated by enzymatic degradation in vitro. The hypoglycemic effect of the drug delivery system was observed by normal rat abdominal glucose tolerance test (IPGTT). Results The average particle size of insulin delivery system was (466 ± 111) μm. The drug delivery system could effectively slow down the degradation of insulin by intestinal digestive enzymes. IPGTT assay showed that the administration system had obvious hypoglycemic Effect (P <0.01). Conclusion The nano-scaffold delivery system designed and prepared in this experiment has the effect of increasing oral absorption of polypeptide drugs such as insulin.