用均匀设计法优选水溶性药物缓释片的制备工艺

APPLICATION OF UNIFORM DESIGN METHOD TO THE PREPARATION OF SUSTAINED RELEASE TABLET OF WATER SOLUBLE DRUG

目的 :研究水溶性药物缓释片处方筛选与工艺优化的方法。方法 :以氟化钠为模型药物 ,采用均匀设计 ,在综合指标中引入“释放区间”量化释放特性 ,考察不同处方、工艺对此指标的影响程度。结果 :经均匀设计多元回归得到优化条件 ,其方程预测值与试验值结果一致 ,优化所得处方工艺合理 ,产品缓释特性好。结论 :“释放区间”作为缓释片释放特性描述的指标 ,为水溶性药物缓释片的处方筛选与工艺优化提供了可供参考的方法。

OEJECTIVE:To achieve the method of the optimal formulation and technology on sustained release dosage form of water soluble drugs.METHODS:Using uniform designed sodium fluoride as a model drug.The “interval of released amount' was introduced to quantify the release characteristics.RESULTS:The optimized condition was obtained and the predictive results of the uniform design was the same as the actual experiment result.CONCLUSION:The research provided a method for the preparation of sustained release dosage form of water soluble drugs.