化学对照品引湿性研究路线的探讨

Research routes of hygroscopicity of chemical reference substances

目的探讨化学对照品引湿性研究的应用路线,为药品质量和用药安全奠定基础。方法主要采用动态水分吸附分析法(DVS)开展引湿性研究,DVS设定温度为25℃,载气N_(2)流速200 mL·min^(-1),程序调控相对湿度变化和时间。结果结合溴吡斯的明研究实例,较系统地解析了3步骤的化学对照品引湿性研究路线。结论相关研究路线的探讨有助于加强基于水分吸附的化学对照品引湿性研究。

Objective To investigate the research routes of hygroscopicity of chemical reference substances.Methods Dynamic vapor absorption analysis(DVS)was mainly used to study related hygroscopicity.During the analysis with DVS,the temperature was 25℃,the gas flow rate of N_(2)was 200 mL·min^(-1),and the relative humidity changes and time were program-controlled.Results Based on a case study of pyridostigmine bromide,the three-step research routes of hygroscopicity of chemical reference substances were analyzed in depth.Conclusion Studies on related research routes can contribute to research on hygroscopicity of chemical reference substances based on water adsorption.