Chinese Journal of Pharmacovigilance ›› 2026, Vol. 23 ›› Issue (8): 852-858.
DOI: 10.19803/j.1672-8629.20260074

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Assessment of pollution and probabilistic carcinogenic risk of Pb, Cd and As in Lonicerae Flos

Liao Chang1,2, Liu Jialin3,Δ, Zuo Tiantian2, Lin Yongqiang2, Cheng Xianlong2, Ren Yating4, Wang Yanyan4, Wang Yannan4#, Kong Dejuan4,*   

  1. 1Key Laboratory of Drug Quality Control and Pharmacovigilance (China Pharmaceutical University), Ministry of Education, Nanjing Jiangsu 210009, China;
    2National Institutes for Food and Drug Control, State Key Laboratory of Drug Regulatory Science, Beijing 102629, China;
    3Tianjin Center for Disease Control and Prevention, Tianjin 300011, China;
    4Tongliao Market Detection and Testing Center, NMPA Key Laboratory of Quality Control of Traditional Chinese Medicine and Mongolian Medicine, Tongliao Inner Mongolia 028000, China
  • Received:2026-01-23 Online:2026-08-15 Published:2026-08-17

Abstract: Objective To establish a framework for assessment of pollution by heavy metals and harmful elements and the probabilistic carcinogenic risk that is consistent with the usage of traditional Chinese medicine (TCM). Methods The contents of lead (Pb), cadmium (Cd), and arsenic (As) in 41 batches of Lonicerae Flos derived from Lonicera macranthoides were determined via inductively coupled plasma mass spectrometry (ICP-MS). Levels of contamination were assessed using the single-factor pollution index and the Nemerow comprehensive pollution index. The probabilistic carcinogenic risk was also studied based on Monte Carlo simulation combined with the carcinogenic risk (CR) model. Results After correction by the transfer rate, the single-factor pollution indices ranged from 0.00 to 0.52 for Pb, 0.01 to 0.63 for Cd, and 0.00 to 0.11 for As, with Cd being the primary contributing pollutant. The Nemerow comprehensive pollution index ranged from 0.01 to 0.34, indicating an overall pollution level from safe to slight contamination. The probabilistic carcinogenic risk assessment suggested that the carcinogenic risks attributable to Cd and As in Lonicerae Flos warranted attention in both general and high-exposure populations. Conclusion An integrated approach to assessment of contamination and probabilistic carcinogenic risk of heavy metals and harmful elements in Lonicerae Flos derived from Lonicera macranthoides has been established, which is expected to provide technical support for safety evaluation of TCM and for the formulation or revision of relevant regulatory limit standards.

Key words: Lonicerae Flos, Lead (Pb), Cadmium (Cd), Arsenic (As), Heavy Metals, Single Factor Pollution Index Method, Nemerow Comprehensive Index Method, Monte Carlo Simulation

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