正交设计法优化复方氢溴酸右美沙芬糖浆的处方工艺

Studies on the Preparation of Compound Dextromethorphan Syrup by Orthogonal Design

探讨使用正交设计方法对多组分口服溶液的处方工艺进行优化。方法:以复方氢溴酸右美沙芬糖浆为模型药物,采用正交设计,在评价指标中引入综合评分来量化稳定性和口感,考察不同处方、工艺对此指标的影响程度。结果:经正交设计回归得到优化条件,其预测值与试验结果一致,优化所得处方工艺合理,产品稳定性及口感好。结论:使用正交设计,以综合评分为指标,可用于含多种主辅料成分的糖浆处方筛选与工艺优化。

Objective:To achieve the method of the optimal formulation and technology on syrup form of complicated materials.Methods:Using orthogonal designed compound dextromethorphan syrup as a model drug.The grade point synthesized was introduced to quantify the stability characteristics.Results:The optimal condition was obtained and the predictive results of the orthogonal design was the same as the actual experiment results.Conclusion:The research provided a method for the preparation of syrup form of complicated materials.The results of the test showed it can be reasonable that using orthogonal design to optimize the formulation of syrup with complicate composition.