节点文献
基于“绿色检验”大环境下的药用辅料“溶液颜色检查法”的未来发展趋势
The future development trend in the color of solution test for pharmaceutical excipients under the Green Test environment
【摘要】 分析“绿色检验”形势下的药用辅料溶液颜色检查法的未来发展趋势。通过筛查有溶液颜色检查项目的药用辅料品种并对比目前国内外溶液检查法所用的标准比色溶液的差异及其在CIELab颜色空间上的分布来阐明色差计法应用于颜色检查法的优势。药用辅料共有131个品种需要对其本身或其溶液进行颜色测定,其中固体辅料有104种,液体辅料有27种,具有非常广阔的应用前景;对比分析了各国的标准比色液,从《中华人民共和国药典》(Chp)中6个色调共66种色号、欧洲药典(EP)中5个色调共37个色号以及美国药典(USP)中的20个色号三者在CIELab空间中的ΔE分布来看,《中华人民共和国药典》设定的色调色号分布较为均匀广泛,线性关系良好,更有利于色差计法的推行。
【Abstract】 To analyze the future development trend in the color of solution test for pharmaceutical excipients under the green test environment. The advantages of colorimeter method was clarified by screening pharmaceutical excipients in pharmacopoeia with color test, comparing the differences and the distribution in CIELab color space of the standard colorimetric solutions at home and abroad. There are 131 kinds of pharmaceutical excipients that need to be tested for color, including 104 kinds of solid excipients and 27 kinds of liquid excipients. The standard colorimetric solutions from various countries were analyzed, according to the ΔE distribution of 66 colors in 6 hues in Chinese Pharmacopoeia(Chp), 37 colors in 5 hues in European Pharmacopoeia(EP), and 20 colors in United States Pharmacopoeia(USP) in CIELab space, the distribution of hues and colors in Chp was more uniform and extensive, had a good linear relationship, which was more conducive to the implementation of the colorimeter method.
【Key words】 pharmaceutical excipients; color test; colorimeter; green test; development trend;
- 【文献出处】 中国新药杂志 ,Chinese Journal of New Drugs , 编辑部邮箱 ,2024年22期
- 【分类号】R927.1
- 【下载频次】39