氯沙坦钾氢氯噻嗪渗透泵片的制备及星点设计优化处方

Preparation of controlled osmotic pump tablets of losartan potassium and hydrochlorothiazide and the optimization of formulation by central composite design

目的:研究氯沙坦钾氢氯噻嗪渗透泵控释片的制备工艺并优化处方。方法:使用星点设计-效应面优化法对处方进行确定,优化和验证。结果:根据效应图得到最优处方:包衣增重3.96%,致孔剂PEG4000的用量为2.61%,打孔的孔径为0.4 mm。结论:星点设计-效应面法可用于氯沙坦钾氢氯噻嗪渗透泵控释片的处方优化,所建模型具有良好的预测能力。

Objective： To prepare controlled osmotic pump tablets of compound losartan potassium and hydrochlorothiazide, and optimize the formulation. Methods： Central composite design-response surface methodolo- gy was used to determine and optimization the formula. Results： An optimal formulation was obtained based on the optimal experimental conditions. The optimal formulation was as follows： the weight gain in coating was 3.96%, content of PEG 4000 was 2.61% , and the number of the release orifice was 0.4 mm. Conclusion ： The CCDRSM can be applied to optimize the formulation of controlled monolithic osmotic pump tablets of compound losartan potas- sium and hydrochlorothiazide, and the established model is of satisfactory predictive value.