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N2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 analysis (DVS) was applied to study on the hygroscopicity of acarbose reference substance. During the analysis with DVS, the temperature was set at 25 ℃, the N2 gas flow rate was 200 mL·min-1, and the relative humidity changes and time were regulated and controlled in program. Results: The hygroscopicity of acarbose reference substance 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%. Conclusion: 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.
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