目的: 以“浙八味”为对象,研究建立中药材中丙烯酰胺含量的通用测定方法,并根据测定结果进行初步风险评估。方法: 样品经过优化的QuEChERS技术提取后,采用同位素内标-超高效液相色谱-串联质谱(UHPLC-MS/MS)法测定丙烯酰胺的含量,以Phenomenex Kinetex C18色谱柱(100 mm×2.1 mm,1.7 μm)为固定相,以甲醇-0.1%甲酸水溶液为流动相进行梯度洗脱,以13C3丙烯酰胺为内标,以多反应监测(MRM)模式进行检测丙烯酰胺的残留量。结果: 247批样品中丙烯酰胺的含量范围为0~26 403 μg·kg-1,含量超过部分国家或组织的规定,长期使用存在一定的安全风险。结论: 本研究所建立的方法快速、简单,具有较好的灵敏度与重复性,为“浙八味”等道地中药材中丙烯酰胺的质量控制和安全性评价提供了科学依据。
周颖, 徐哲, 张文婷, 周越美, 徐潇颖, 赵维良, 潘英妮, 郑成
. 同位素内标-UHPLC-MS/MS联用QuEChERS法检测“浙八味”等道地药材中丙烯酰胺含量及初步风险评估*[J]. 药物分析杂志, 2024
, 44(6)
: 1017
-1023
.
DOI: 10.16155/j.0254-1793.2024.06.12
Objective: To determine the content of acrylamide in “8 famous medicines from Zhejiang”, and to carry out the preliminary risk assessment based on the determination results. Methods: After optimization of QuEChERS extraction, the content of acrylamide was determined by the method of isotope-labeled internal standard-ultra high performance liquid chromatography-tandem mass spectrometry (isotope-labeled IS-UHPLC-MS/MS). The determination was carried out with a Phenomenex Kinetex C18 column (100 mm×2.1 mm, 1.7 μm) as the stationary phase, gradient elution was carried out with methanol-0.1% formic acid aqueous solution as the mobile phase, 13C3 acrylamide as the internal standard, and multiple reaction monitoring (MRM) mode was used to detect the residual acrylamide. Results: The content ranges of acrylamide in 247 batches of samples were 0-26 403 μg·kg-1. These contents exceeded the regulations stipulated by some nations or organizations, and posed certain safety risks in long-term use. Conclusion: The method established in this study is rapid, simple, sensitive and reproducible, and will lay a scientific basis for the quality control and safety evaluation of acrylamide in “8 famous medicines from Zhejiang” and other genuine medicinal materials.
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