Abstract: The 0.3 g of xiao'er ganmao granule sample was taken, and 5 mL of nitric acid and 2 mL of 30% (mass fraction) hydrogen peroxide solution were added. After mixing evenly and soaking overnight, the mixture was digested by microwave at 195 ℃ for 45 min through the heating program. The solution was heated at 100 ℃ until about 1-2 mL of the digestion solution remained. The residue was transferred to a 50 mL-volumetric flask with 5% (volume fraction, the same below) nitric acid solution, and 200 μL of 1 mg·L⁻¹ Au standard solution was added. The mixed solution was diluted to the mark with 5% nitric acid solution for determination of 22 elemental impurities, including B, Al, V, Cr, Mn, Fe, Co, Ni, Cu, Zn, As, Se, Sr, Mo, Cd, Sn, Sb, Ba, Pt, Hg, Tl, Pb by inductively coupled plasma mass spectrometry (ICP-MS). Mixed internal standards were added online for calibration of elemental signal response values. The health risks posed by 22 elemental impurities to the human body were evaluated using the maximum limit theoretical value, the daily allowable exposure for oral administration given by the ICH Q3D guideline for elemental impurities published by the International Council on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), hazard coefficient, and comprehensive hazard index. It was shown that linear relationships between values of the mass concentrations of elemental impurities and signal response values corrected by internal standard were kept in definite ranges, with detection limits (3s/k) in the range of 0.001-0.401 mg·kg⁻¹. Test for recovery was made according to the standard addition method, giving recoveries in the range of 85.1%-104%, and RSDs of the determined values were not greater than 5.5%. The proposed method was used for the analysis of 31 batches of samples, and there were some differences in the content of 22 elements in samples from different manafacturers, but the changing trends were basically the same. The detected amounts of the 22 elemental impurities were all below the maximum limit theoretical value, and the ICH Q3D guideline for elemental impurities allows for daily exposure for oral use. The hazard coefficient and comprehensive hazard index were all less than 1, indicating that there was no significant health risk for the 22 elemental impurities. However, 16 out of 31 batches of samples had a comprehensive hazard index higher than 0.7, indicating that there might be a potential risk of elemental impurity contamination in xiao'er ganmao granules, which should be continuously monitored.