Objective: To achieve a comprehensive understanding, assess health risk and set limits of heavy metals and harmful elements in Naoliqing pills. Methods: Residues of Pb, Cd, As, Hg and Cu in 52 batches of samples from 7 manufacturers were determined by microwave digestion-inductively coupled plasma mass spectrometry (ICP-MS). Radio-frequency power of ICP was 1 300 W, atomizer gas flow rate was 1.0 L·min-1, carrier gas flow rate was 1.2 L·min-1, plasma gas flow rate was 17.0 L·min-1, and sampling depth was 3 mm. Based on the procedures including hazard identification, hazard characterization, exposure assessment and risk characterization, risk assessment was performed and theoretical value of the maximum limit of Pb, Cd, As, Hg and Cu in the drug were calculated. Results: The ratio of samples with health risk was 17.3%, involving 9 batches of samples from 4 manufacturers,which implied health risk of Naoliqing pills. The average of target hazard quotients (THQs) of Pb and As, which were 0.75 and 0.61, were obviously higher than the average of THQs of Cd, Hg and Cu, which were 0.07, 0.13 and 0.09. It implied that the health risk of Pb and As were higher than Cd, Hg and Cu in Naoliqing pills.Residual limits of Pb, Cd, As, Hg and Cu in the drug were formulated as 4.0, 2.5, 10, 2, 150 mg·kg-1, respectively, on the basis of theoretical value of the maximum limit. Conclusion: The method established in this research, which is accurate and efficient,can be used to the determination and risk assessment of Pb, Cd, As, Hg and Cu residues in Naoliqing pills. And it can provide reference for clinical medication safety of Naoliqing pills and safety research of other drugs.
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