首批醋酸去氨加压素国家对照品的研制  

Standardization of the National Reference Standard of Desmopressin Acetate

作　　者：刘莉莎[1] 郝苏丽[1] 任雪[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》2011年第3期245-247,共3页Chinese Pharmaceutical Affairs

摘　　要：目的建立首批醋酸去氨加压素国家对照品。方法应用红外光谱、液质联用仪等对醋酸去氨加压素进行结构确证,采用HPLC法测定纯度、检测醋酸含量及氨基酸比值,采用3种方法进行含量测定。结果确定首批醋酸去氨加压素对照品的含量为87.0%。结论首批醋酸去氨加压素国家对照品的建立可有效控制产品质量。Objective To establish the national reference standard of desmopressin acetate.Methods IR,LC-MS Spectrometer and polariscope were used to confirm the structure of desmopressin acetate.HPLC was used to determine the purity,the content of acetic acid and the ratio of amino acid.And 3 kinds of methods were used to detect the content of desmopressin acetate.Results The structure of the material has been confirmed and the content was 87.0%.Conclusion The establishment of national reference standard of desmopressin acetate can efficiently control the quality of drugs.

关 键 词：醋酸去氨加压素 去氨加压素 对照品 

分 类 号：R973.1[医药卫生—药品]