中心复合设计法优化盐酸氨溴索缓释片处方

Optimization of ambroxol hydrochloride sustained release tablets by Central Composite Design

目的 :采用山榆酸甘油酯作为基本骨架材料 ,制备了日服一次的盐酸氨溴索缓释片。方法 :通过单因素实验考察药物释放的影响因素 ,确立处方组成 ;采用中心复合设计试验对处方进行优化。结果 :山榆酸甘油酯和乳糖的量为药物释放的主要影响因素 ,以综合评分值为考察指标拟合所得多元二次方程为Y =10 5 .9390 - 1.1116X1- 0 .2 6 86X2 +0 .0 0 81X12 -0 .0 0 4 9X1X2 +0 .0 0 2 1X2 2 ,复相关系数r =0 .8387。结论 :中心复合设计优化处方预测性良好 ,制得盐酸氨溴索缓释片符合实验设计要求。

OBJECTIVE A sustained release tablet of ambroxol hydrochloride was designed and prepared by using Compritol ○R888 ATO as basic matrix material. METHODS The formulation was developed, based on single-factor tests, which were carried out to screen the critical factors influncing the drug release. The optimal formulations was obtained by Central Composite Design. RESULTS Compritol ○R 888 ATO and lactose were the main factors , and the grading values of synthesizing were selected as the response variable. Second-order polynomial and linear equation was Y= 105.9390- 1.1116X 1 - 0.2686X 2+ 0.0081X 12- 0.0049X 1X 2+ 0.0021X 22,and th e regression coefficient was 0.8387. CONCLUSION Central Composite Design was successfully used to op timize the preparation of sustained release tablet of ambroxol hydrochloride. Th e tablets comply with the requirements of the experiment design.