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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。
OBJECTIVE: To screen and optimize the preparation process of miconazole nitrate micelles by uniform design to provide controllability and predictability, and to study the stability and drug release of microspheres. Methods: Microspheres were prepared by emulsion cross-linking method. The U5 (53) test table was used to test the morphologies, particle sizes, drug loading and entrapment efficiency of the prepared microspheres. Using SPSS software for multiple linear regression fitting, equations and optimize the process conditions. Results: There is a good agreement between the predicted value of the optimization equation and the experimental value. The prepared microspheres can be stored at room temperature (25 ℃); drug release kinetics of microspheres can be described by the first-order kinetic equation. Conclusion: In this experiment, the preparation method of miconazole nitrate microspheres was optimized and the prepared microspheres had good performance by uniform design.