法莫替丁钙镁咀嚼片有关物质控制工艺研究

Control Process of Related Substances in Famotidine Calcium Carbonate and Magnesium Hydroxide Chewable Tablets

目的:对法莫替丁钙镁咀嚼片制备工艺进行系统研究,确定能够控制该产品有关物质的制备工艺。方法:通过分析法莫替丁钙镁咀嚼片处方的组成,找出影响产品有关物质的因素。应用β-环糊精与羟丙基β-环糊精分别包合研究,找出最佳的包合技术,而后采用分别制粒方法,从而解决法莫替丁钙镁咀嚼片有关物质不合格问题。结果:法莫替丁钙镁咀嚼片有关物质不合格是由法莫替丁与氢氧化镁相结合引起的,采用羟丙基β-环糊精包合技术制成的法莫替丁钙镁咀嚼片的有关物质得到了很好的解决。结论:该有关物质控制工艺稳定,可行,可操作性强,可以运用于法莫替丁钙镁咀嚼片的大生产。

Objective： To study the Preparation Process of Famotidine Calcium Carbonate and Magnesium Hydroxide Chewable Tablets （FCMCT） ,To determine the control process of related substances in FCMCT. Method： By analyzing the FCMCT prescription form, I- dentifying the factors that affect the product-related substances, Studying on the separation inclusion using β-CD and hydro-β-CD, Iden- tifying the best inclusion technique. Then using the separation granulation method to solve the problem of related substances unqualified in FCMCT. Result： Magnesium hydroxide combined with famotidine caused the unqualified related substances in FCMCT, Related sub- stances in FCMCRT has been well resolved by using hydro-β-CD inclusion technique. Conclusion： The related substances control process is stable, feasible, and workable. Fully applied to large production for FCMCT.