Chinese Journal of Pharmacovigilance ›› 2024, Vol. 21 ›› Issue (9): 1008-1013.
DOI: 10.19803/j.1672-8629.20240039

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Twenty-eight elements in Coicis Semen and risk assessment by stir-frying with bran by inductively coupled plasma-mass spectrometry

GUO Yuansheng1,2, ZUO Tiantian1△, LIU Li'na1, WEI Feng1, DONG Zhe1, LI Jing1, JIN Hongyu1#, MA Shuangcheng3,*   

  1. 1Institute for Contral of Chinese Traditinal and Ethnic Medicine, National Institutes for Food and Drug Control, Beijing 100050, China;
    2School of Pharmacy, China Pharmaceutical University, Nanjing Jiangsu 211198, China;
    3Chinese Pharmacopoeia Commission, Beijing 100061, China
  • Received:2024-01-19 Online:2024-09-15 Published:2024-09-14

Abstract: Objective To establish a method for determination of 28 elements in Coicis Semen by stir-frying with bran, and evaluate the risks of these toxic elements in order to facilitate quality control of Coicis Semen. Methods After microwave digestion, the samples were analyzed by inductively coupled plasma mass spectrometry (ICP-MS) and the risk of Pb, Cd, As, Hg and Cu was assessed. Results The linearity of each element was good. The precision was less than 3.0% and the recovery ranged from 81.2% to 112.0%. The contents of K, Mg, Ca, Fe, Zn, Mn, Al and Na in Coicis Semen by stir-frying with bran were higher (>50 mg·kg-1), while those of Cu, B, Li, Ni, Ba, Sr, Mo, Cr and Ti were lower (1~5 mg·kg-1). V, Se, Co, As, Pb, Be, Cd, Ag, Tl, Au, Hg, Sb were trace elements (<1 mg·kg-1). According to the limits of heavy metals and harmful elements in botanical medicines stipulated in the current 2020 edition of Chinese Pharmacopoeia (hereinafter referred to as the Chinese Pharmacopoeia) (Part I), the same amounts of lead, cadmium and cadmium were found in the 15 batches of Coicis Semen by stir-frying with bran. The pass rate of lead, cadmium, arsenic, mercury and copper in the 15 batches of Coicis Semen by stir-frying with bran was 100%. Risk assessment showed that the hazard indices (HI) of Pb, Cd, As, Hg and Cu in the 15 batches of Coicis Semen by stir-frying with bran were less than 1, indicating that the risk was acceptable. Conclusion The multi-element analytical method developed in this study has a high sensitivity and good specificity, which, combined with risk assessment techniques, can provide a reference for quality control of Coicis Semen by stir-frying with bran.

Key words: Coicis semen by stir-frying with bran, elements, inductively coupled plasma mass spectrometry (ICP-MS), determination, risk assessment

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