色差计法测定注射用丹参多酚酸溶液的颜色

Color Difference Meters Measuring the Color of Salvianolate Lyophilized Injection Solution

目的:利用色差计建立注射用丹参多酚酸溶液颜色测定的方法。方法:采用《中华人民共和国药典》2010版附录XIA"溶液颜色检查法"第三法(色差计法)测定溶液的颜色。结果:该方法精密度和重复性良好,3 h内色差值△E*的RSD值为1.28%。测定的6批样品均小于黄色3号标准比色液(Y3)。结论:相比目视法,该方法将溶液颜色进行了量化检测、数据直观准确,可作为注射用丹参多酚酸溶液颜色测定的方法。通过色差法对中药注射剂质量进行控制将成为一种趋势,对提高中药注射剂安全性具有重要意义。

Objective ： To establish a method based on color difference meters for measuring the color of salvianolate lyophilized injection solution. Methods ：The solutions color is determined by the ChP 2010 -Appendix IXA color of solution- the third meth- od（ color difference method）. Results： The method has good precision and repeatability, the stability of 3 h was below 1.28% （RSD）. Six samples＇colors were not deeper than the yellow 3rd standard solution（Y3）. Conclusion ： Compared with the method by visualization,the chromatic aberration method gives a more objective and precision determination result, and can be applied to measure the color of salvianolate lyophilized injection solution. Using the chromatic aberration method to control the quality of tra- ditional Chinese medicine injection will become a trend of great significance to improve the security of traditional Chinese medi- cine injections.