甘氨酰-谷氨酰胺双肽中有关物质的影响因素考察  

Study on influencing factors of related substances degraded from glycyl-glutaminedipeptide

作　　者：王珍珍[1] 于小月[1] 李茜[1] 闫碧涵 储婷[1] 马伟从[1] 毛声俊[1] 

机构地区：[1]四川大学华西药学院靶向药物及释药系统教育部重点实验室,四川成都610041

出　　处：《华西药学杂志》2013年第5期482-485,共4页West China Journal of Pharmaceutical Sciences

摘　　要：目的 考察温度、加热时间及pH对甘氨酰-谷氨酰胺（Gly-Gln）双肽有关物质的影响,为确定其合理的制剂生产工艺与储存条件提供参考.方法 配制与市售制剂相同浓度的Gly-Gln溶液,将pH分别为4、5、6、7、8、9的供试品溶液分别置80℃、100℃、115℃、121℃下加热,在预设的时间点取样,采用HPLC法测定其有关物质焦谷氨酸、环甘氨酰-谷氨酰胺的含量.结果 Gly-Gln双肽在弱酸性（pH5 ～6）中较其在弱碱性（pH8 ～9）溶液中更稳定;在各pH条件下,随着温度升高、加热时间延长,有关物质含量均显著增加.结论 温度、加热时间及pH对Gly-Gln双肽的稳定性具有显著影响,最适宜的pH应为5～6.OBJECTIVE To study the effects of temperature,heating time and solution pH value on related substances degraded from glycyl - glutamine dipeptide. METHODS The glycyl - glutamine solutions were prepared to the concentration which is same as in the commercial product. Compound amino acids （ 15 ） and dipeptides （2） adjusted with a series of pH value ranging from 4 to 9 can make prepared solutions,which were undergone acceleration tests at 80 ℃, 100 ℃, 115 ℃ and 121 ℃ ,respectively. Each aliquot sampled atpredetermined time points was assayed for related substances （circle glycyl - glutamine and pyroglutamic acid degraded from glycyl -glutamine dipeptide） by HPLC method. RESULTS The glycyl -glntamine dipeptide in the acidic solution （pH5 -6） were more stable than in the alkaline solution（ pH8 -9 ）. The amounts of related substances in all tested solutions increased with higher heating temperature and longer time, and regardless of their pH differences. CONCLUSION Heating temperature, time and pH value have great effects on stability of the glycyl - glutamine dipeptide and the optimal pH value are recommended to be between 5 and 6.

关 键 词：甘氨酰-谷氨酰胺 环甘氨酰-谷氨酰胺 焦谷氨酸 有关物质 稳定性 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]