关于第十三批磷酸组织胺国家对照品的协作标定  

Collaborative Calibration of the 13th National Reference Standard for Histamine Phosphate

作　　者：刘倩[1] 吴彦霖[1] 张媛[1] 贺庆[1] 高华[1] 胡宇驰[2] 芮菁[3] 祝清芬[4] 

机构地区：[1]中国食品药品检定研究院,北京100050 [2]北京市药品检验所 [3]天津市药品检验所 [4]山东省食品药品检验所

出　　处：《中国药事》2014年第12期1335-1338,共4页Chinese Pharmaceutical Affairs

摘　　要：目的制备、标定第十三批磷酸组织胺国家对照品（批号150510-201313）。方法用第十二批磷酸组织胺国家对照品（批号150510-200412）为标准,采用猫血压法标定。结果此批待标品经4个实验室的标定结果合并计算效价为99.1%。结论此批产品可以作为第十三批磷酸组织胺国家对照品使用。此批国家对照品相对效价定为100%,即1mg的磷酸组织胺相当于0.342mg的组织胺。Objective To prepare and to standardize national reference standard for histamine phosphate（150510-201313）.Methods The potencies of the national reference standard for histamine phosphate were assayed by the 12 th national reference standard for histamine phosphate（150510-200412）with the cat blood pressure method.Results The potency of histamine phosphate was calculated as 99.1% based on consolidation of the calibration results from four laboratories.Conclusion The 13 th national reference standard for histamine phosphate was established to replace the 12 th reference standard.The determined relative potency of histamine phosphate is100%,that is,1mg histamine phosphate is equivalent to 0.342 mg histamine.

关 键 词：磷酸组织胺 对照品 效价 

分 类 号：R927.3[医药卫生—药学] R96