胞磷胆碱钠胶囊稳定性研究  

Study on the Stability of Citicoline Sodium Capsules

作　　者：李涛[1] 胡青大 刘红丽[1] 吕明明[1] 任冬雪[1] 王春晖[1] 赵海南[1] 

机构地区：[1]北京中医药大学东方学院中药系化学研究组,河北廊坊065000 [2]富士康精密电子工业有限公司冲模开发,河北廊坊065000

出　　处：《广东化工》2015年第10期43-44,共2页Guangdong Chemical Industry

摘　　要：文章主要考察了胞磷胆碱钠胶囊在贮存过程中药物稳定性,采用高效液相色谱法测定胞磷胆碱钠胶囊中胞磷胆碱的含量,通过光照试验、高温试验、高湿试验、长期试验、加速试验,考察样品稳定性。结果,本品连续三批经过影响因素试验和加速试验6个月和长期试验6个月的考察,其各项指标均在质量标准规定的范围内,得到胞磷胆碱钠胶囊的性质比较稳定。The paper mainly investigates the stability of drug during storage Citicoline Sodium Capsules, the content of citicoline is determined by high performance liquid chromatography, through the light test, high temperature test, high humidity test, long-term test, accelerated test, and investigated the sample stability. The results of investigation, three consecutive batches of products are detected by the test of influencing factors and accelerated test for 6 months and long-term test for 6 months, the Citicoline Sodium Capsules indicators are in the range of quality standards within the prescribed, experimental results show that the Citicoline Sodium Capsules relatively stable.

关 键 词：胞磷胆碱钠胶囊 加速试验 长期试验 稳定性 

分 类 号：TQ[化学工程]