马来酸依那普利片稳定性研究

目的 提高马来酸依那普利片的稳定性。方法 将马来酸依那普利原料和碳酸氢钠以1:3的摩尔比溶解在水中，作为粘合剂使用。结果 通过原辅料相容性试验表明，处理后的API与各辅料相容性较好，杂质没有明显变化；通过制剂的加速6个月试验表明：杂质C由0.15%增长至0.61%，杂质D由未检出增长到0.48%；通过长期12个月的数据表明：杂质C由0.15%增长至0.42%，杂质D由未检出增长至0.1%。结论 通过原辅料相容性和稳定性考察结果显示，该工艺有效解决了马来酸依那普利制剂稳定性不好的问题。

Study on stability of Enalapril Maleate Tablets

Objective To improve the stability of Enalapril Maleate Tablets.Methods The enalapril maleate and sodium bicarbonate were dissolved in water at a molar ratio of 1:3 and used as a binder.Results The compatibility test showed that the compatibility of the API with the excipients was good and the impurities did not change significantly.The 6-month accelerated test showed that the impurity C increased from 0.15% to 0.61% and the impurity D was from none-detection to 0.48%;12 months of long-term data showed that:impurity C increased from 0.15% to 0.42%, impurity D increased from none-detection to 0.1%.Conclusion The results showed that the process can effectively solve the problem that the stability of enalapril maleate was not good.