目的 运用动态水分吸附分析技术对不同化学对照品的水分吸附特性进行研究分析,以指导化学对照品标定时分装条件、包装用瓶以及使用方式的确定。方法 采用动态水分吸附分析技术对5种不同引湿性类型的化学对照品原料进行分析,测定水分吸附动力学曲线,评价化学对照品在不同湿度条件下吸收水分的趋势和程度。结果 根据水分吸附动力学曲线,判断依替膦酸二钠、对氨基水杨酸钠、盐酸伐昔洛韦、阿司匹林和波生坦等化学对照品的引湿性,确定了这几种化学对照品适宜的分装环境、包装用瓶和使用方式。结论 动态水分吸附分析技术能够实时记录水分吸附数据,直观观察到化学对照品在不同环境湿度条件下与水分相互作用的程度,从而判断化学对照品的引湿性,是化学对照品标定工作中重要的分析方法。
Abstract
OBJECTIVE To investigate the moisture sorption properties of chemical reference substances (CRSs) by using dynamic vapor sorption (DVS) analysis technology in order to establish the distribution conditions, packaging materials, and usages of national chemical reference substances. METHODS DVS analysis was adopted to acquire the moisture sorption dynamic profiles of five chemical reference substances of different moisture sorption types to evaluate their moisture sorption trend and capacities under different humidities.RESULTS According to moisture sorption dynamics, we can found the hygroscopicity of disodium etidronate, sodium aminosalicylate, valaciclovir hydrochloride, aspirin and bosentan, and we have given advices about how to use these CRSs and what kind of bottles they should be packed in. CONCLUSION DVS analysis can be used to record moisture sorption data in real time and visually observe water-CRS interactions under different humidities, which is an important technology for guiding the establishment and distribution of CRSs.
关键词
动态水分吸附 /
水分吸附动力学曲线 /
吸附-解吸附等温线 /
引湿性 /
依替膦酸二钠 /
对氨基水杨酸钠 /
盐酸伐昔洛韦 /
阿司匹林 /
波生坦
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Key words
dynamic vapor sorption /
moisture sorption dynamics /
adsorption-desorption isotherm /
hygroscopicity /
disodium etidronate /
sodium aminosalicylate /
valaciclovir hydrochloride /
aspirin /
bosentan
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中图分类号：
R917
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参考文献
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脚注
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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中青年发展研究基金资助项目(2010A3)
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