70mg阿仑膦酸钠片生产工艺的筛选及优化

Confirm and optimize the manufacturing process of Alendronate sodium tablets

目的:确定阿仑膦酸钠片的生产工艺并对其进行优化。方法:对该产品的处方和工艺进行筛选及优化。结果:筛选的处方操作过程极为简单,操作和工艺条件易于掌握和实施,质量易于控制,产品收率高,产品质量符合药典规定。结论:筛选后的处方和工艺切实可行,适用于工业化的大生产。

Objective：To confirm and optimize the manufacturing process of Alendronate sodium tablets. Methods：To screen and optimize the formula and process of Alendronate sodium tablets. Results：The screened formula and process were very easy to operating; the process and critical conditions were apt to grasp and implement; the quality was easy to control; the yield was high and the quality of the product meeted the CP requirements. Conclusion：The screened formula and process are feasibility and applicable to commercial manufacturing.