首批脱氧核糖核酸国家对照品的研制  

Standardization of the National Standard of Deoxyribonucleic Acid

作　　者：刘莉莎[1] 任雪[1] 邓利娟[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》2015年第9期917-920,共4页Chinese Pharmaceutical Affairs

摘　　要：目的:建立首批脱氧核糖核酸国家对照品。方法:对脱氧核糖核酸原料进行了鉴别、元素分析、纯度及理化特性分析,并采用质量平衡法、定磷法及吸光度法对其含量进行计算。结果:建立了以脱氧核糖核酸计含量为75.2%的首批脱氧核糖核酸国家对照品。结论:首批脱氧核糖核酸国家对照品的研制成功规范了相关药品质量,保证了用药安全。Objective： To establish the fi rst batch of the national reference standard for deoxyribonucleic acid（DNA）. Methods： The identifi cation and metal element analysis were performed, and the purity test of the DNA material was analyzed. Three different methods were used to calculate the content of DNA. Results： The content of the DNA was 75.2 %. Conclusion： The established national reference standard of DNA can be applied to the quality control of drugs.

关 键 词：脱氧核糖核酸 质量分析 首批 国家对照品 

分 类 号：R917[医药卫生—药物分析学]