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Traditional Chinese Medicine (TCM) has gained worldwide popularity due to its natural therapeutic properties. However, China’s export share accounts for only about 1% of the global herbal medicine market, valued at 40 billion USD, primarily due to quality concerns such as pesticide residues, heavy metals, and mycotoxins. This review systematically examines the current contamination status, regulatory frameworks, and detection technologies for chemical hazards in Chinese medicinal materials.For pesticide residues, we analyze the evolution of legal standards from the Chinese Pharmacopoeia (2015–2025 editions) in comparison to international regulations (USP, EP, KP, JP). Despite the implementation of strict maximum residue limits (MRLs) for 33–47 banned pesticides, studies have revealed alarming contamination rates: 94.57% of herbal samples contain pesticide residues, with some exceeding limits by up to 500-fold. We identify three major contamination pathways: direct pesticide application, environmental absorption (from soil, water, or air), and secondary contamination during processing or storage. The review also evaluates the impact of processing methods (washing, peeling, drying, ethanol extraction) on residue levels, as measured by processing factors (PF) ranging from 0.0002 to 0.98.Regarding heavy metals (Pb, Cd, Hg, As, Cu), we compare limit standards across pharmacopoeias and elucidate bioaccumulation mechanisms via root absorption and environmental deposition. Our analysis extends to mycotoxin contamination, detailing the prevalence of aflatoxin B₁ (detection rates exceeding 60% in certain herbs), deoxynivalenol, ochratoxin A, and zearalenone, alongside their toxicological mechanisms and international regulatory limits.This paper comprehensively reviews detection methodologies, from conventional chromatography (GC, HPLC) to advanced techniques (LC-MS/MS, SFC-MS/MS, molecularly imprinted polymers, and immunoassays), emphasizing their sensitivity, selectivity, and suitability for complex herbal matrices. Additionally, we assess the impact of processing techniques on contaminant reduction, noting that washing and peeling significantly reduce residues, whereas drying may concentrate them.Our analysis underscores the urgent need for standardized cultivation practices, harmonized international standards, and advanced quality control measures to ensure the safety of TCM and enhance its competitiveness in the global market.

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Risk Assessment for the Process from Planting to Processing of Rhizoma polygonati, Panax notoginseng, and Portulaca oleracea

  • 章节

  • 发表日期：

    2026年

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  • Lin Yang,
  • Jun Yan,
  • Tian Yang,
  • Jianda Chen,
  • Li Minmin

摘要

Traditional Chinese Medicine (TCM) has gained worldwide popularity due to its natural therapeutic properties. However, China’s export share accounts for only about 1% of the global herbal medicine market, valued at 40 billion USD, primarily due to quality concerns such as pesticide residues, heavy metals, and mycotoxins. This review systematically examines the current contamination status, regulatory frameworks, and detection technologies for chemical hazards in Chinese medicinal materials.For pesticide residues, we analyze the evolution of legal standards from the Chinese Pharmacopoeia (2015–2025 editions) in comparison to international regulations (USP, EP, KP, JP). Despite the implementation of strict maximum residue limits (MRLs) for 33–47 banned pesticides, studies have revealed alarming contamination rates: 94.57% of herbal samples contain pesticide residues, with some exceeding limits by up to 500-fold. We identify three major contamination pathways: direct pesticide application, environmental absorption (from soil, water, or air), and secondary contamination during processing or storage. The review also evaluates the impact of processing methods (washing, peeling, drying, ethanol extraction) on residue levels, as measured by processing factors (PF) ranging from 0.0002 to 0.98.Regarding heavy metals (Pb, Cd, Hg, As, Cu), we compare limit standards across pharmacopoeias and elucidate bioaccumulation mechanisms via root absorption and environmental deposition. Our analysis extends to mycotoxin contamination, detailing the prevalence of aflatoxin B₁ (detection rates exceeding 60% in certain herbs), deoxynivalenol, ochratoxin A, and zearalenone, alongside their toxicological mechanisms and international regulatory limits.This paper comprehensively reviews detection methodologies, from conventional chromatography (GC, HPLC) to advanced techniques (LC-MS/MS, SFC-MS/MS, molecularly imprinted polymers, and immunoassays), emphasizing their sensitivity, selectivity, and suitability for complex herbal matrices. Additionally, we assess the impact of processing techniques on contaminant reduction, noting that washing and peeling significantly reduce residues, whereas drying may concentrate them.Our analysis underscores the urgent need for standardized cultivation practices, harmonized international standards, and advanced quality control measures to ensure the safety of TCM and enhance its competitiveness in the global market.