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Quality Control WP1

Quality Control WP1. Braga, Portugal, July 2011 Monique S.J. Simmonds on behalf of the many people that have helped this WP get us as far as it has. Objectives. Design a standard system for the quality control of Chinese herbal medicines (CHM) in the EU;

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Quality Control WP1

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  1. Quality Control WP1 Braga, Portugal, July 2011 Monique S.J. Simmonds on behalf of the many people that have helped this WP get us as far as it has

  2. Objectives • Design a standard system for the quality control of Chinese herbal medicines (CHM) in the EU; • Design a system that will provide greater transparency about the complexity of TCM nomenclature, thus clarifying plant identities and improving data gathering • Propose guidelines as a basis for the rational development of research methods to authenticate and monitor the quality of TCM plants entering the trade. Maximise the use of modern molecular and chemical techniques, especially a functional genomic approach.

  3. Tasks Henley meeting 2010 D1.1 - Preliminary list of species (over 100 species) D1.3 - Priority list of species ‘classical’ herbal TCM formula ‘Liu Wei Di Huang Wan’ (6-flavoured Rehmannia pill)

  4. ‘Liu Wei Di Huang Wan’ • Rhizoma Alismatis’, • ‘Fructus Corni’, • ‘Rhizoma Dioscoreae’, • ‘Cortex Moutan’, • ‘Poria’, • ‘Radix Rehmanniae Praeparata’

  5. Quality Control • “appropriate” name used • Correct species --- DNA /morphology “image applications” Quality and chemistry – “right profile” Unprocessed – processed Extraction methods – Geographic/environmental factors Standards – markers - vouchers

  6. Substructure (MS2) Mass:charge (MS1) Surface chemistry (LC) Marker compound

  7. Substructure (MS2) Mass:charge (MS1) Surface chemistry (LC) Finding the profile of “active” molecules in plant

  8. Quality Control Issues relating to quality Supply of material Export of material (restrictions on samples being taken out of China: clarity of permits needed) Substitutes /adulterants

  9. 2008-2009 6 32 7 3 12 24

  10. 3D representation of LC-MS profile Taxonomic compounds Active compounds Kite/Simmonds et al. unpublished

  11. Supply: quality control Obtaining supply of quality plants Urgent need to do this This links with International Conventions – EU Directives - D 1.9 Target audiences – need different information

  12. ‘Business as usual is not an option.’ What does this mean for conservation and those interested in increased use of biodiversity, improved agriculture, - research? Changes in land use in China having impact on land available for growing plants = move from wild harvesting to cultivated material October 30 2006

  13. Global Strategy for Plant Conservation “Conservation and sustainable use of plants used in TCM” Adopted World Summit 2002 16 targets to deliver Targets revised Dublin Ireland 2010

  14. TCM: and GSPC • Main areas of activity internationally: • Target 1: A widely accessible working list of known plant spp., as a step towards a complete world flora • Target 2: A preliminary assessment of the conservation status of all known plant spp. • Target 8: 60% of threatened plant spp. in accessible ex situ collections, preferably in country of origin, and 10% included in recovery and restoration programmes

  15. Plant conservation in China • 33,000 vascular plants (50-60% are endemic: e.g. Camellia 98 in China, 21 in rest of the world) of which 24,667 are represented in botanical collections in China • Red listed species: 1992=388; 2004 = 4408 (TCM 500) • 3,000 natural conservation area (16% of land area; 1980=70; 2010=160 botanic gardens)

  16. Plant Biodiversity in China • Crop plants: 300 of the 15,000 crop plants come from China • Ornamentals: 60% of the 7,500 traded come from China • Medicinal: 8000 species – about 2000 TCM

  17. Target 12:Managing plant products sustainably Progress Health – Agriculture WP 1 Implement • Biodiversity Strategies • Sustainable Development Strategy • GAP guidelines - TCM • Forestry Standards, Organic Action plans • Best practise LEAF (Linking Environment & Farming) • CAP reforms cross compliance, Natura 2000 network

  18. What information are we gathering • Names • Where plants are growing • How they are grown • Are they processed/how • Chemisty (as to above) • Chemistry and activity (often still needs to be done) • Single species to mixture - the real TCM

  19. Plant names • Legacy of GP-TCM • Wellcome Trust grant £685,850 over 3 yrs List scientific names, trivial names, trade names and CAS numbers etc

  20. Key points Links with other WPs - bring the data together Quality control criteria for reviewing papers and input into the future = SOP Are we gathering the appropriate information ???

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