均匀设计法优化秋水仙碱渗透泵控释片的衣膜处方

Membrane formulation optimization of osmotically controlled release tablets of colchicine with uniform design

目的:研制秋水仙碱渗透泵控释片,建立衣膜参数与释药速率之间的相关性。方法:利用均匀设计法获得释药速率与控释衣膜厚度(醋酸纤维素)和增塑剂用量(PEG6000)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,据此制备的秋水仙碱渗透泵控释片符合零级释药方式(r=0.9902)。结论:采用均匀设计法优化初级渗透泵控释片的处方简便、有效。

To prepare controlled release tablets of colchicine and establish the relationship among formula factors of membrane and drug release rate. METHODS ： Uniform design was used to achieve the quantitative relationship among the release rate of colchicine, acetyl cellulose and PEG 6000. Optimized prescriptions were calcu- lated from the regression equation. RESULTS： A significant correlation and a fine precision were obtained. Osmotically controlled release tablets of colchicine were prepared based on the calculations, and the drug release pattern was in accordance with zero-order kinetics （ r = 0.990 2 ）. CONCLUSION ： Uniform design is a convenient and efficient approach to the formulation optimization of elementary osmotic-pump tablets.