Evaluation of exogenous residual contamination in Traditional Chinese Medicine formula granules and the three-dimensional risk assessment using HI-P-CV method.

The residues of heavy metals, pesticides and mycotoxins in 42 types of traditional Chinese medicine formula granules (TCMFGs) were determined by inductively coupled plasma mass spectrometry (ICP-MS), high-performance liquid chromatography tandem mass spectrometry (HPLC-MS) and gas chromatography tandem mass spectrometry (GC-MS). The results showed that the detection rate of seven types of heavy metals was 100%. Among the 143 types of pesticides, 78 were detected, with an average detection rate of 24.72%. Of the 57 types of mycotoxins, 14 were detected, with an average detection rate of 38.30%. Using the hazard index method, a three-dimensional risk assessment framework based on hazard index (HI), prevalence (P), and variability (CV) (HI-P-CV framework) is established. The HI values were 0.73 for heavy metals, 0.03 for pesticides and 0.54 for mycotoxins, individually. The CV values were 59.15%, 59.54% and 42.57%, respectively. The model revealed significant variation in contamination levels among three categories of residues in TCMFGs, indicating hidden risks. Cumulative dietary risk assessment identified 18 varieties with potential health risks, including 10 high-risk varieties. The average cumulative dietary risk was 1.3, indicating a relatively high overall risk of exogenous residue contamination in TCMFGs. Profile analysis indicated that varieties with aerial medicinal parts tend to accumulate heavy metals and should be prioritized for heavy metal contamination monitoring. Varieties with underground medicinal parts, which are rich in polysaccharides, are more susceptible to fungi contamination. The detection of banned pesticides and widespread presence of plant growth regulators highlight the need for stricter regulation of pesticide use.