title: Combined DNA, toxicological and heavy metal analyses provides an auditing toolkit to improve pharmacovigilance of traditional Chinese medicine (TCM).
abstract: 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.
authors.affiliation: Trace and Environmental DNA laboratory, Department of Environment and Agriculture, Curtin University, Kent St, Bentley, WA, 6102, Australia.
authors.forename: Megan L
authors.initials: ML
authors.lastname: Coghlan
authors.affiliation: 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.
authors.forename: Garth
authors.initials: G
authors.lastname: Maker
authors.affiliation: 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.
authors.forename: Elly
authors.initials: E
authors.lastname: Crighton
authors.affiliation: Trace and Environmental DNA laboratory, Department of Environment and Agriculture, Curtin University, Kent St, Bentley, WA, 6102, Australia.
authors.forename: James
authors.initials: J
authors.lastname: Haile
authors.affiliation: Trace and Environmental DNA laboratory, Department of Environment and Agriculture, Curtin University, Kent St, Bentley, WA, 6102, Australia.
authors.forename: Dáithí C
authors.initials: DC
authors.lastname: Murray
authors.affiliation: Trace and Environmental DNA laboratory, Department of Environment and Agriculture, Curtin University, Kent St, Bentley, WA, 6102, Australia.
authors.forename: Nicole E
authors.initials: NE
authors.lastname: White
authors.affiliation: School of Medical Sciences, The University of Adelaide, Frome Rd, Adelaide, SA, 5005, Australia.|Forensic Science SA, Adelaide, SA, 5000, Australia.
authors.forename: Roger W
authors.initials: RW
authors.lastname: Byard
authors.affiliation: Centre for Comparative Genomics, Murdoch University, South St, Murdoch, WA, 6150, Australia.
authors.forename: Matthew I
authors.initials: MI
authors.lastname: Bellgard
authors.affiliation: 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.
authors.forename: Ian
authors.initials: I
authors.lastname: Mullaney
authors.affiliation: Separation Science and Metabolomics Laboratory and the Advanced Mass Spectrometry Facility, Murdoch University, South St, Murdoch, WA, 6150, Australia.
authors.forename: Robert
authors.initials: R
authors.lastname: Trengove
authors.affiliation: 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.
authors.forename: Richard J N
authors.initials: RJ
authors.lastname: Allcock
authors.affiliation: Forensic Science SA, Adelaide, SA, 5000, Australia.
authors.forename: Christine
authors.initials: C
authors.lastname: Nash
authors.affiliation: School of Medical Sciences, The University of Adelaide, Frome Rd, Adelaide, SA, 5005, Australia.
authors.forename: Claire
authors.initials: C
authors.lastname: Hoban
authors.affiliation: Trace Research Advanced Clean Environment (TRACE) Facility, Department of Physics, Astronomy and Medical Radiation Sciences, Curtin University, Kent St, Bentley, WA, 6102, Australia.
authors.forename: Kevin
authors.initials: K
authors.lastname: Jarrett
authors.affiliation: Trace Research Advanced Clean Environment (TRACE) Facility, Department of Physics, Astronomy and Medical Radiation Sciences, Curtin University, Kent St, Bentley, WA, 6102, Australia.
authors.forename: Ross
authors.initials: R
authors.lastname: Edwards
authors.affiliation: School of Medical Sciences, The University of Adelaide, Frome Rd, Adelaide, SA, 5005, Australia.
authors.forename: Ian F
authors.initials: IF
authors.lastname: Musgrave
authors.affiliation: Trace and Environmental DNA laboratory, Department of Environment and Agriculture, Curtin University, Kent St, Bentley, WA, 6102, Australia.
authors.forename: Michael
authors.initials: M
authors.lastname: Bunce
mesh_terms: D004340:Drug Contamination; D004365:Drugs, Chinese Herbal / Q000737:chemistry* / Q000494:pharmacology* / Q000633:toxicity; D006801:Humans; D008516:Medicine, Chinese Traditional / Q000009:adverse effects / Q000592:standards*; D019216:Metals, Heavy / Q000032:analysis* / Q000633:toxicity; D060735:Pharmacovigilance; D018675:Toxicity Tests / Q000379:methods
chemical_list: D004365:Drugs, Chinese Herbal; D019216:Metals, Heavy