Objective: To non-targeted rapid screen and realize the risk assessment of heavy metals and toxic elements in Xinnaojian capsules by inductively coupled plasma mass spectrometry (ICP-MS). Methods: After microwave digestion, ICP-MS was used for non-targeted determination of heavy metals and toxic elements. The determination conditions were as follows: the plasma gas flow rate was 15.0 L · min-1, the peristaltic pump speed was 0.20 r · s-1, the temperature of the nebulization chamber was 2 ℃, the auxiliary gas flow rate was 0.8 L · min-1,the carrier gas flow rate was 0.8 L · min-1, the RF power was 1 550 W, the number of measurement points was 6, the number of scans was 100, the number of repetitions was 1, the collision mode was He mode, and the analysis mode was semi-quantitative. According to the basic steps of risk assessment, while the risks of Ni, Pb, Al, Mn and Cu were evaluated. Results: The residues of Pb, Cd, Hg and Cu in Xinnaojian capsules were lower than the limits of the current 2020 Chinese Pharmacopoeia.The results of multi-element determination show that, the contents of Fe,Mn,Zn,Mg which were necessary for human body were abundant, with content ranges of 77.75-100.82 mg · kg-1, 5.71-10.05 mg · kg-1, 12.38-33.38 mg · kg-1, 65.02-537.65 mg · kg-1. The results of risk assessment showed that the daily exposure of heavy metals and toxic elements in Xinnaojian capsules was in the order: Al>Ni>Cu>Mn>Pb. The non-carcinogenic risk of Ni, Pb, Al, Mn and Cu could be accepted. Conclusion: The combination of non-targeted rapid screen analysis method and risk assessment technology can quickly determine the concentration range and risk status of harmful target elements in Xinnaojian capsules, and provide scientific and technical support for effective response to accidents caused by traditional Chinese medcines.
KONG De-juan
,
JIN Hong-yu
,
BAO Ming-lan
,
WANG Yan-yan
,
ZUO Tian-tian
,
Zhu Yan-hong
. Study on rapid screening and risk assessment of multi elements in Xinnaojian capsules*[J]. Chinese Journal of Pharmaceutical Analysis, 2025
, 45(4)
: 696
-701
.
DOI: 10.16155/j.0254-1793.2024-1374
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