促红细胞生成素双层微条的处方筛选与工艺优化研究

Study on Optimization of Formulation and Preparation of Collagen Double Layer Minipellet of Erythropoietin

目的对促红细胞生成素(EPO)胶原蛋白双层微条的处方及工艺进行筛选优化。方法采用正交试验,以偏离度为评价指标,得到胶原蛋白与EPO含量比、硫酸软骨素钠(CS)含量、喷嘴外管内径和微条长度4个因素的最佳取值。结果筛选得到胶原蛋白与EPO含量比为1000∶1,CS含量为1%,喷嘴外管内径为1．4mm,微条长度为15mm。结论根据得到的最优处方制备的双层微条释放缓慢、平稳。

Objective To investigate optimization of formulation and preparation of collagen double layer minipellet of erythropoietin. Methods The orthogonal experimental design was chosen to optimize the condition of formulation with the main variables： collagen/erythropoietin ratios, contents of sodium chondroitin sulfate, diameters of extrusion nozzles and lengths of double layer minipellet. The results were evaluated by the numeric value of deviation. Results The optimal values of collagen/erythropoietin ratios, contents of sodium chondroitin sulfate, diameters of extrusion nozzles and lengths of minipellets were 1 000 ： 1, 1%, 1.4 mm and 15 mm, respectively. Conclusion The results showed that the release of erythropoietin from double layer minipellet prepared by the optimal formulation proved sustained and steady.