首批酪丝亮肽国家对照品的研制  

Development of the First Batch National Reference Substance for Tyroserleutide

作　　者：廖海明[1] 任雪[1] 李勇 郝苏丽[1] 杨化新[1] 范慧红[1] 

机构地区：[1]中国食品药品检定研究院,北京100050 [2]深圳市康哲药业有限公司

出　　处：《中国药事》2013年第10期1077-1079,共3页Chinese Pharmaceutical Affairs

基　　金：创新药物研究开发技术平台建设(编号2012ZX09304010)

摘　　要：目的建立首批酪丝亮肽国家对照品。方法应用紫外分光光度计、液质联用仪等对酪丝亮肽进行结构确证,采用反相高效液相色谱法测定纯度及氨基酸比值,采用3种方法进行含量测定。结果确证了酪丝亮肽原料的结构,并确定首批酪丝亮肽对照品含量为96.8%。结论首批酪丝亮肽国家对照品(批号:140742-200701)的建立可有效控制产品质量。Objective To establish the national reference substance for tyroserleutide. Methods UV spectrometer and LC-MS were used to confirm the structure of the material. RP-HPLC were used to determine the purity and the ratio of amino acid of tyroserleutide, and 3 methods were used to determine the content of the material. Results The structure of the material was confirmed, and the content of tyroserleutide was 96.8%. Conclusion The establishment of national reference substance （lot No： 140742- 200701） for tyroserleutide can efficiently control the quality of products.

关 键 词：酪丝亮肽 国家对照品 标准和标定 质谱 反相高效液相色谱法 

分 类 号：R915[医药卫生—微生物与生化药学]