化学药品标准物质维生素B12的引湿性研究  

Hygroscopicity Study of Vitamin B12 Chemical Reference Substance

作　　者：刘毅[1] 吴建敏[1] 严菁[1] 林兰[1] LIU Yi;WU Jian-min;YAN Jing;LIN Lan(National Institutes for Food and Drug Control, Beijing 102629, China)

机构地区：[1]中国食品药品检定研究院

出　　处：《中国药学杂志》2019年第10期809-812,共4页Chinese Pharmaceutical Journal

基　　金：国家科技重大专项“重大新药创制”资助项目(2015ZX09303001);中国食品药品检定研究院学科带头人培养基金资助项目(2015X3)

摘　　要：目的探讨维生素B12的强引湿性及其化学药品标准物质应关注的问题。方法 UV方法(溶剂:水,检测波长361 nm)等研究分析紫外吸收系数,动态水分吸附分析法(DVS)研究不同湿度条件下的水分吸收趋势和程度。结果维生素B12的强引湿性,使得称量可能引入的偏差导致其紫外吸收系数分析偏小,特别是样品干燥后或者水分含量较低时表现得尤为明显。结论维生素B12的相关药品质量研究应该关注其原料强引湿性的影响,化学药品标准物质维生素B12的研发和应用特别需要重视引湿性。OBJECTIVE To investigate the hygroscopicity of vitamin B12 and the related problems of its chemical reference substance (CRS) that should be paid attention to. METHODS UV absorption coefficient was determined at 361 nm, using water as solvent. Dynamic vapor absorption analysis (DVS) was applied to evaluate the moisture sorption trend and capacities of vitamin B12 under different humilities. RESULTS Owing to the strong hygroscopicity of vitamin B12, deviation in the process of weighing might result in smaller UV absorption coefficient compared with the actual value, especially for dried and low moisture content raw materials in high-humidity environment. CONCLUSION In the study of drug quality control for vitamin B12, the strong hygroscopicity of the raw material should be paid attention to, particularly in the research and application of vitamin B12 CRS.

关 键 词：维生素B12 引湿性 化学药品标准物质 紫外分光光度法 动态水分吸附分析法 热重分析法 

分 类 号：R917[医药卫生—药物分析学]