首批醋酸去氨加压素国家对照品的研制-中国药事.PDF

2011 253 245 刘莉莎, 郝苏丽, 任 雪, 范慧红( , 100050) : 建立首批醋酸去氨加压素国家对照品 应用红外光谱液质联用仪等对醋酸去氨加压 素进行结构 证, 采用HPL 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 定首批醋酸去氨加压素对照品的含量为870% 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 : 醋酸去氨加压素; 去氨加压素; 对照品 : R9731 : A :(2011) Standardization of theNational Reference Standard of Desmopressin Acetate Liu Lisha, Hao Suli, Ren Xue and Fan Huihong(National Institutes for Food and Drug ontrol, Beijing 100050) ABSTRACT: Objective T o establish the national reference standard of desmopressin acetate Methods IR, L MS Spectrometer and polariscope were used to confirm the structure of desmopressin acetate HPL 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 870% Conclusion T he establishment of national reference standard of desmopressin acetate can efficiently control the quality of drugs EYWORDS: desmopressin acetate; desmopressin; reference substance ) ; ( , 1 8D ) ; 18 ( 8L, ) ; [ 14] , , ; , 2 21 , 3, , 32; 32; 4000; Sample gain 10; Mirror 1 velocity 06329; Aperture 10000 Thermo Nicolet NEXUS FTIR ; 22 Thermo Finigan L Q DE A XP Plus ; , ESI 5KV, Perkin Elmer Model 343 Plus; 8arb, 1 (L 20AD , Sil20A , SPD20A 10g mL ) ; Mettler XS205; Metrohm 684KF 23 1 ; SMS DVS2 ; Mettler 1% 2mg mL , Toledo MP230 ; NIRS ( 24 : , , ; : ; T el: ( 010) 67095481