国家药品标准物质阿卡波糖的引湿性研究  

Study on the hygroscopicity of national reference substance of acarbose

作　　者：刘毅[1] 郭贤辉 覃玲[1] 严菁[1] 陈华[1] LIU Yi;GUO Xian-hui;QIN Lin;YAN Jing;CHEN Hua(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,北京102629

出　　处：《药物分析杂志》2023年第8期1429-1434,共6页Chinese Journal of Pharmaceutical Analysis

基　　金：中国食品药品检定研究院化学药品检定所重点实验室学科建设项目(2023HYZX25)。

摘　　要：目的:考察强引湿性标准物质阿卡波糖研发过程中需要注意的应用性问题。方法:采用动态水分吸附分析法(DVS)开展阿卡波糖标准物质的引湿性研究,DVS设定温度为25℃,载气N_(2)流速200 mL·min^(-1),程序调控相对湿度(RH)变化和时间。结果:目前阿卡波糖国家药品标准物质的原料工艺较早期的引湿性减弱,建议选择本工艺水分含量3.5%的标准物质原料,质控实验室应用时合理控制环境湿度不大于RH45%,称量同步进行并尽量控制在10 min内完成。结论:引湿性受生产工艺、水分含量和环境因素影响,需要加强有明显引湿性标准物质的应用性研究。Objective:To investigate the hygroscopicity related problems that need to be addressed in the research and development of strong hygroscopic acarbose reference substance.Methods:Dynamic vapor absorption analy⁃sis(DVS)was applied to study on the hygroscopicity of acarbose reference substance.During the analysis with DVS,the temperature was set at 25℃,the N_(2)gas flow rate was 200 mL·min^(-1),and the relative humidity chan⁃ges and time were regulated and controlled in program.Results:The hygroscopicity of acarbose reference sub⁃stance in the present material process has been weakened compared to the early batch.Raw materials of acarbose reference substance with 3.5%water content was recommended,and it was recommended to complete the weighing process within 10 minutes in the quality control laboratory with the ambient humidity not to exceed RH45%.Con⁃clusion:The hygroscopicity was affected by material process,water content and other ambient conditions.Further researches and precautions should be taken when dealing with strong hygroscopic reference substances.

关 键 词：阿卡波糖 引湿性 动态水分吸附 

分 类 号：R917[医药卫生—药物分析学]