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Sci Rep. 2015 Dec 10;5:17475. doi: 10.1038/srep17475.

Combined DNA, toxicological and heavy metal analyses provides an auditing toolkit to improve pharmacovigilance of traditional Chinese medicine (TCM).

Author information

Trace and Environmental DNA laboratory, Department of Environment and Agriculture, Curtin University, Kent St, Bentley, WA, 6102, Australia.
Separation Science and Metabolomics Laboratory and the Advanced Mass Spectrometry Facility, Murdoch University, South St, Murdoch, WA, 6150, Australia.
School of Veterinary and Life Sciences, Murdoch University, South St, Murdoch, WA, 6150, Australia.
School of Medical Sciences, The University of Adelaide, Frome Rd, Adelaide, SA, 5005, Australia.
Forensic Science SA, Adelaide, SA, 5000, Australia.
Centre for Comparative Genomics, Murdoch University, South St, Murdoch, WA, 6150, Australia.
LotteryWest State Biomedical Facility Genomics, School of Pathology and Laboratory Medicine, University of Western Australia, 35 Stirling Hwy, Crawley, WA, 6009, Australia.
Department of Diagnostic Genomics, Pathwest Laboratory Medicine WA, QEII Medical Centre, Hospital Ave, Nedlands, WA, 6009, Australia.
Trace Research Advanced Clean Environment (TRACE) Facility, Department of Physics, Astronomy and Medical Radiation Sciences, Curtin University, Kent St, Bentley, WA, 6102, Australia.


Globally, there has been an increase in the use of herbal remedies including traditional Chinese medicine (TCM). There is a perception that products are natural, safe and effectively regulated, however, regulatory agencies are hampered by a lack of a toolkit to audit ingredient lists, adulterants and constituent active compounds. Here, for the first time, a multidisciplinary approach to assessing the molecular content of 26 TCMs is described. Next generation DNA sequencing is combined with toxicological and heavy metal screening by separation techniques and mass spectrometry (MS) to provide a comprehensive audit. Genetic analysis revealed that 50% of samples contained DNA of undeclared plant or animal taxa, including an endangered species of Panthera (snow leopard). In 50% of the TCMs, an undeclared pharmaceutical agent was detected including warfarin, dexamethasone, diclofenac, cyproheptadine and paracetamol. Mass spectrometry revealed heavy metals including arsenic, lead and cadmium, one with a level of arsenic >10 times the acceptable limit. The study showed 92% of the TCMs examined were found to have some form of contamination and/or substitution. This study demonstrates that a combination of molecular methodologies can provide an effective means by which to audit complementary and alternative medicines.

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