女金丸中合成染料的检测及其染色部位分析-中国药事.pdf

中国药事 2019年3月 第33卷 第3期 263 ·质量评价· 女金丸中合成染料的检测及其染色部位分析 * * 何轶，张聿梅，鲁静，于建东，戴忠 ，马双成 （中国食品药品检定研究院，北京 100050） 摘要 目的： 方法： 对女金丸中的合成染料进行检测，分析其染色部位，并推断可能的染色原因。 采用 液相色谱和质谱联用法，对女金丸样品中的合成染料进行测定，并采用液相色谱分别对丸剂外层和内层 的合成染料进行测定，以判断其染色部位。结果：样品中可检出苋菜红、亮蓝和日落黄 3 种合成染料； 上述染料主要集中于丸剂外层，丸剂内层未检出或仅可检出微量上述染料。结论：在制剂过程中使用了 苋菜红、亮蓝和日落黄对丸剂外层进行染色，以改善制剂外观性状，应规范制剂工艺流程。 关键词：女金丸；合成染料；染色部位；液相色谱质谱联用 R917 A 1002-7777(2019)03-0263-07 中图分类号： 文献标识码： 文章编号： doi:10.16153/j.1002-7777.2019.03.005 Detection of Synthetic Dyes in Nujin Pills and Analysis of the Staining Position * * He Yi, Zhang Yumei, Lu Jing, Yu Jiandong, Dai Zhong , Ma Shuangcheng (National Institutes for Food and Drug Control, Beijing 100050, China) Abstract Objective: To detect synthetic dyes in Nujin pills, analyze the dyeing position and the possible causes of dyeing. Methods: The synthetic dyes in Nujin pills were detected by HPLC-MS. The synthetic dyes in the inner and outer layers of the pills were detected by HPLC-DAD to determine the dyeing position. Results: The synthetic dyes, such as amaranth, brilliant blue and sunset yellow could be detected in Nujin pills; those synthetic dyes were mainly concentrated in the outer layer of the pills, and were undetectable or only present in trace amounts in the inner layer of the pills. Conclusion: Amaranth, brilliant blue and sunset yellow were used to dye the outer layer of the pills during the process to improve the appearance of the preparations. The process procedure of the preparations should be standardized. Keywords: Nujin pills; synthetic dye; staining position; HPLC-MS 中药依靠其独特的疗效、