首批N(2)-L-丙氨酰-L-谷氨酰胺国家对照品的研制  

Development of First Batch of National Reference Standard of N(2)-L-alanyl-L-glutamine

作　　者：廖海明[1] 任雪[1] 杨红淼[1] 郝苏丽[1] 范慧红[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国药事》2013年第9期959-962,共4页Chinese Pharmaceutical Affairs

摘　　要：目的建立首批N(2)-L-丙氨酰-L-谷氨酰胺国家对照品。方法应用红外光谱、液质联用仪等对N(2)-L-丙氨酰-L-谷氨酰胺进行结构确证,采用HPLC法测定纯度及氨基酸比值,采用3种方法进行含量测定。结果确定首批N(2)-L-丙氨酰-L-谷氨酰胺对照品的含量为99.8%。结论首批N(2)-L-丙氨酰-L-谷氨酰胺国家对照品可用于N(2)-L-丙氨酰-L-谷氨酰铵及其制剂的定性和定量控制。Objective To establish the first batch of the national reference standard of N （2）- L-glutamine. Methods The IR spectrometer and LC-MS were used to confirm the structure of N alanyl-L-glutamine. HPLC was used to determine the purity and the ratio of amino acid. Three methods were used to detect the content of N （2） -L-alanyl-L-glutamine. Results The structu first batch of the national reference standard of N （2） -L-alanyl-L-glutamine was confirmed content was 99.8%. Conclusion The first batch of the national reference standard of N （2） -L- glutamine can be used for quality and quantity controls of N （2）-L-alanyl-L-glutamine preparatmns. L-alanyl- （2） -L- kinds of re of the and the alanyl-L- and its

关 键 词：N(2)-L-丙氨酰-L-谷氨酰胺 对照品 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]