均匀设计法优化硝酸咪康唑微球的制备工艺

目的：以均匀设计法筛选优化硝酸咪康唑苹果酸化壳聚糖微球的制备工艺，提供可控性及预测性，并对微球稳定性和药物释放规律进行研究。方法：采用乳化交联法制备微球。采用U5（53）试验表进行试验，分别考察各处方的制备的微球的形态和粒径、载药量和包封率。利用SPSS软件进行多元线性回归拟合，得到方程及优化工艺条件。结果：优化方程的预测值与实验值之间有较好的吻合性。制备出的微球可以在室温（25℃）条件下保存；微球的药物释放动力学可用一级动力学方程来描述。结论：本实验通过均匀设计法优化硝酸咪康唑微球的制备工艺预测性好且制备的微球性能良好。

Process Optimization of Miconazole Nitrate Malic acid-Chitosan Microspheres Preparation Technology by Uniform Design

Objective： To optimize the preparation of miconazole nitrate malic acid-chitosan microsphere with uniform test design, the stability and release of microsphere were studied. Method： The miconazole nitrate malic acid-chitosan microsphere was prepared by emulsion-chemical cross-link method. The uniform design with 5 levels and 3 factors was employed to screen five formulae of miconazole nitrate malic acid-chitosan microsphere. The equation and condition was gained by SPSS soft dealing with the date. Results： The results showed that the determined and predicted values were accordant. The microsphere could be stored at 25℃ ; the release kinetics of microsphere was described by first-order kinetics equation. Conclusions： The preparation of the miconazole nitrate malic acid- micro- spheres could be forecasted and the characteristic of microspheres was excellent.