贝诺酯分散片的制备及质量控制

Preparation and Quality Control of Benorylate Dispersible Tablets

目的探讨贝诺酯分散片的制备工艺及质量控制方法。方法以崩解时间为指标筛选辅料的种类;采用紫外分光光度法测定贝诺酯分散片在5 min内的累积溶出量,通过正交试验筛选出最优处方。结果优化最佳处方为微晶纤维素42%,羧甲淀粉钠13%,淀粉2%,硬脂酸镁0.5%。结论所制备的贝诺酯分散片具有良好的溶出度,15 min内即可溶出90%,2.5 min内完全崩解,且符合分散片的其他要求。

Objective To study the preparation technology and the quality control method of Benorylate Dispersible Tablets.Methods The variety of auxiliary materials was selected by the disintegration time as index and the 5 min accumulation of dissolution was determined by UV spectrophotometry.The optimal prescription was screened by the orthogonal design method.Results The optimal formulation contained 42%microcrystalline cellulose,13%sodium carboxy methyl starch,2%starch and 0.5%magnesium stearate.Conclusion Benorylate Dispersible Tablets prepared by the optimal prescription has better dissolution,90%is dissoluble in 15 min and complete disintegration is within 2.5 min,which accords with the other indexes of the dispersible tablets.