赤芍总苷微孔渗透泵控释片的处方优化研究

Formulation optimization of controlled porosity osmotic-pump tablets of total paeony glycosides

目的:研制赤芍总苷微孔渗透泵控释片,考察衣膜处方与体外释药特性之间的关系。方法:利用均匀设计法获得释药速率与衣膜组分之间的定量关系,通过回归方程预测并优化处方。结果:回归方程的显著性和准确性较好,据此制备的赤芍总苷微孔渗透泵片符合零级释药方式(r=0.990 2)。结论:采用均匀设计法优化微孔渗透泵控释片的处方快捷、高效。

Objective： To prepare controlled porosity osmotic-pump tablets of total paeony glycosides （TPG） and establish the relationship between formulation factors of membrane and drug release rate. Method： Uniform design was used to achieve the quantita- tive relationship between the release rate and formulation factors of membrane. Optimized prescription was calculated from the regres- sion equation. Result： A significant correlation and a fine precision of the regession equation were obtained. Controlled porosity osmotic-pump tablets of TPG were prepared based on the calculations, and the drug release profile was in accord with zero-order kinetics （ r = 0. 990 2）. Conclusion： Uniform design is a convenient and efficient approach for formulation optimization of controlled porosity osmotic-pump tablets.