Determination and Risk Assessment of Heavy Metals and Harmful Elements Residues in Pediatric Oral Liquid Preparations of Traditional Chinese Medicine Based on ICP-MS

OBJECTIVE  To establish a semi-quantitative and a quantitative method for screening determination of heavy metals and harmful elements residues in pediatric oral liquid preparations of traditional Chinese medicine by inductively coupled plasma mass spectrometry(ICP-MS), and to carry out the risk assessment.

METHODS  After microwave digestion treatment of 43 species with 54 samples, the semi-quantitative method was used to scan and estimate the concentration of all elements, and then the quantitative method was established for the simultaneous determination of 13 heavy metals and harmful elements(V, Cr, Co, Ni, Cu, As, Se, Ag, Cd, Ba, Hg, Tl, Pb). Hazard index(HI) was used to carry out the risk assessment of 5 heavy metals and harmful elements(Hg, Pb, As, Cd, Cu).

RESULTS  The Hg residues in 2 samples were exceeded the prescribed limit of Chinese Pharmacopoeia 2020 edition and the Pb residue in 1 sample was exceeded the prescribed limit of ICH Q3D. The HI of 5 heavy metals and harmful elements in all samples were less than 1.

CONCLUSION  The proposed method is accurate and efficient. It can be used for the determination of heavy metals and harmful elements residues in common pediatric oral liquid preparations of traditional Chinese medicine. The evaluation results indicate that there have no significant health risk in the absorption process of children.