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Study on stability of Enalapril Maleate Tablets
Author(s): 
Pages: 335-337
Year: Issue:  6
Journal: Qilu Pharmaceutical Affairs

Keyword:  马来酸依那普利稳定性有关物质;
Abstract: 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,处理后的原料药(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.
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