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Christine Leon 1 , Lin Yu-Lin 2 , Chen Shilin 2 , Monique Simmonds 1 , Debbie Shaw 3

Authenticating Chinese medicinal plants for patient safety and conservation - a Western perspective. Christine Leon 1 , Lin Yu-Lin 2 , Chen Shilin 2 , Monique Simmonds 1 , Debbie Shaw 3 1 Royal Botanic Gardens, Kew, UK 2 IMPLAD, Chinese Academy of Medical Sciences, Beijing, China

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Christine Leon 1 , Lin Yu-Lin 2 , Chen Shilin 2 , Monique Simmonds 1 , Debbie Shaw 3

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  1. Authenticating Chinese medicinal plantsfor patient safety and conservation- a Western perspective Christine Leon1, Lin Yu-Lin2, Chen Shilin2, Monique Simmonds1, Debbie Shaw3 1 Royal Botanic Gardens, Kew, UK 2 IMPLAD, Chinese Academy of Medical Sciences, Beijing, China 3 Medical Toxicology Unit, Guy’s & St Thomas’ Hospital, London

  2. Outline • need for TCM plant reference materials & authentication services in the West • UK/China collaboration • our work in China • our work in UK • applications • conclusions

  3. The needfor TCM plant reference materials & authentication services in the West

  4. Need for ref materials in West Despite thousands of CM clinics in West and widely reportedmedical benefits 1 of 3000+ clinics in UK

  5. 1. Patient safety concerns: • inadequate herbal QA in West regulations under development e.g. EU Directive on Traditional Herbal Medicinal Products 2004/24/EC - simplified registration scheme - based on long-term traditional use But not effective until 2011! e.g. revision of the UK Medicines Act

  6. 1. Patient safety concerns: - presence of herbal contaminants, unofficial substitutes and counterfeits Wu Jia Pi (Eleutheroccus nodiflorus) Xiang Jia Pi (Periploca sepium) Ba Jiao Hui Xiang (Illicium verum) and toxic substitutes) Counterfeit of Chen Xiang (Aquilaria sinensis)

  7. 1. Patient safety concerns: - confusion about plant identity & plant names “Honeysuckle” “Cxardenia florida, L.” “Scutellaria baicalensis” “Fresh orange peel” “Forsythia suspensa” “Red Paeonia albiflora” “Cicada shell” “Caraway seds” “Rhutarb of Szechuan”

  8. 1. Patient safety concerns: • adverse reactions UK (since ’95): 6 cases of renal failure 38 cases of liver damage/failure - Shaw, D., et al. ‘97 Drug Safety 17(5): 342-356. - Lord, R. et al. ’99. Lancet 354: 7 Aug. - MTU unpublished data

  9. Need for ref materials in West 2. Emerging Western QA standards differ from those in China - need for: - species-specific identification tests - differentiation with common substitutes 3. Species conservation concerns - c. 60-70% TCM plants still wild harvested in China (IUCN-China) - over-harvesting from wild - many threatened; rising international demand 400+ threatened by IUCN criteria 18 spp. on CITES - increases levels of herbal substitutes in trade

  10. 4.Lack of relevant reference plants & materia medica in West Existing plant reference materials at Royal Botanic Gardens, Kew, UK: 40,000 living plant species No corresponding CM materia medica 8 million dried herbarium specimens e.g. Shi Hu

  11. 2. UK/China collaboration

  12. 1998: Chinese Medicinal Plants Authentication and Conservation Collaboration (CMPACC) a joint project Royal Botanic Gardens, Kew & Institute of Medicinal Plant Development, CAMS, Beijing, China in collaboration with Medical Toxicology Unit Guy’s & St Thomas Hospital, London

  13. CMPACC’s status • independent • scientific • not-for-profit • no regulatory powers • funding: • 50% Kew (government) • 50% private

  14. 2. UK/China collaborationCMPACC’s work in China

  15. One of CMPACC’s main aims: To create authentic Chinese plant reference materials - provenanced herbal drugs (materia medica)

  16. 1. Which plant species to include? • official species in Chinese Pharmacopoeia 579 spp. • other Chinese species in global trade c. 50 spp. - possibly many more • substitute/confused plants (common in international trade) c. ? 150 spp. total plant spp.c. 600-750 total materia medica c. 1,300

  17. 2.Where to find the plants in China? 9.5 million sq. km to explore! 30,000 species to choose from (10% world’s plants)

  18. Our work in China Asarum sieboldii (Xi Xin) 1 cm

  19. Areas of high medicinal plant diversity (wild or cultivated) Qinling Shan (Shaanxi province) Tianmu Shan and Huang Shan (Anhui & Zhejiang provinces)

  20. Paeonia suffruticosa (Mudanpi) LARGE-SCALE CULTIVATION 500m in the Qinling Shan, Shaanxi WILD on mountain slopes, 4,500m, near Li Xian, Sichuan Paeonia veitchii (Chishao)

  21. 3. How to recognise them? • technical taxonomic/floristic texts: • Florae Republicae Popularis Sinicae (80 vols) • Flora of China (24 vols – unfinished) • consulting herbarium specimens • first-hand field experience

  22. 4. How to collect the materials and create reference medicines?

  23. Our work in China Harvesting fresh plants at traditional harvest times to ensure quality and alwaysmaking herbarium specimens Making herbarium specimens of Belamcanda chinensis in Hebei province Harvesting Salvia miltiorrhiza

  24. Ourwork in China Harvesting from traditional sites: e.g.Dao Di where chemical quality is optimal (chemo- & geno-types) Codonopsis pilosula (Dang Shen) Min Xian, Gansu province (3,000 m altitude): Dao Di locality

  25. Our work in China Taking DNA samples photography, recording ecological & conservation information

  26. Our work in China Creating crude drugs and Yin Pian • work with local experts to make ‘Yin Pian’ using our own samples • follow methods in CP05 • e.g. • - blanching • - dry-frying • - dry-frying with bran • - stir-frying with honey • - steaming Making ‘Chao Bai Zhu’ by dry-frying rhizomes of Atractylodes macrocephala with bran

  27. Our work in China Finding herbal substitutes & counterfeits: - liaising with local people is one solution ‘Lao Liu’ local expert in Sichuan Local farmer with Coptis deltoidea (Huang Liang) Children in Guizhou

  28. Our work in China Finding herbal substitutes & counterfeits:- scrutinising local markets in China and UK is another option Street market in Yunnan, selling Tian Ma (Gastrodia elata tubers) etc.

  29. Our work in China Substitutes of ‘Huajiao’ (Pericarpium Zanthoxyli); scattered across north and western China Official Zanthoxylum bungeanum Z. schinifolium Unofficial Z. armatum (Zhu Ye Jiao) Z. simulans (Ye Hua Jiao)

  30. Z. bungeanum Z. schinifolium Z. simulans Z. armatum

  31. 1998-2006: 18 provinces

  32. Our work in China Progress (1998-2006) • c. 6,000 plant samples • representing 502 species (CP05, others in international trade & substitutes) = 65-75% coverage

  33. 2. UK/China collaborationOur work in the UK- at RBG Kew

  34. Our work in UK (Kew) Checking identity (verification) of plants collected Taxonomists in the Kew Herbarium • check the identity of our herbarium reference specimens • provide most recent Latin scientific names

  35. Our work in UK (Kew) Checking cross-referencing between herbarium & drug samples created Collection no. TCMK 7 (Huang Qin) Scutellaria baicalensis

  36. Our work in UK (Kew) -including all Yin Pian (decocting styles) created TCMK 12 (Ban Xia) rhizome of Pinellia ternata

  37. Our work in UK (Kew) Storing the materia medica Samples stored in 2 units at Kew – differentcontrolled temperature & humidity A. short-term for authentication services & research (12°C) B. long-term storage security & minimising chemical degradation (minus 30°C)

  38. Our work in UK (Kew) Fingerprinting and researchfor authentication Using samples collected in China: Chemical profiling: • Application of CP05 methods • fingerprint profiles created (TLC, HPLC,GC-MS, LC-MS-MS) • new markers and methods also being researched

  39. Our work in UK (Kew) • CP05 - key reference for identity/quality standards • chemical reference standards difficult to obtain in West • some solvents illegal e.g. benzene • some tests, e.g. HPLC, difficult to validate • tests for differentiating herbal substitutes and adulterants not • included • Kew’s >80 million plant collections especially useful • - enable comparative work • - refining tests to species level Why are new markers and methods needed?

  40. 1149 1119 1119 1149 1119 1119 Panax ginseng (Ren Shen) 1149 1119 1119 1149 1149 1149 1149 1149 1149 Panax quinquefolius (Xi Yuan Shen) 1149 1149 1149 1149 1149 1149 Panax notoginseng (San Qi) 16 18 20 22 24 26 28 Time (min) A new method and marker for ‘ginseng’ species - a LC/MS/MS technique for detecting malonyl-ginsenosides GC Kite, et al. (2003) Rap. Comm. Mass Spect. 17: 238-244. A A A A: authentic T: trade A A T A

  41. Our work in UK (Kew) DNA profiling • 90% samples sequenced (rbcl) • for identification to species-level • detection of plant contaminants • supports chemical tests • some Yin Pian destroys DNA (e.g. Du Zhong Tan) contributes to ‘Global Framework of plant DNA sequences’

  42. 3. applications (not-for-profit)

  43. Resulting plant reference resources & expertise used to: Improve patient safety • authenticating plants implicated in ADR studies - prevention & investigation • advising on plant names used in ADR reporting • WHO herbal pharmacovigilance (Uppsala Sweden) • training resource - students (herbal medicine, pharmacy, ethnobotany)

  44. Contribute to design of emerging Western standards /regulations • helping formulate medicines regulation in West - UK Aristolochia Prohibition Order (2001) - new European Herbal Medicinal Products Directive (THMP) – effective in UK in 2011 • contributing to new identification monographs - British Pharmacopoeia 2007

  45. Promote plant species conservation • providing early warning system for herbs at risk of over-collection • by detecting substitute plants • support to implementation of CITES (Convention on International Trade in Endangered Species) • training of wildlife crime officers; customs inspectors Future • DNA mapping – contributes to design of traceability systems • platform for development ofsustainable harvesting studiesin China

  46. 4. Conclusion • while globalisation of CM enables Western access to its far-reaching medical benefits • recent and related issues in the West notably: - patient safety - inadequate herbal regulation - sustainable supply of plant species • will take time to fully resolve • the provision of scientifically rigorous plant authentication resources can make a contribution.

  47. harnessing East-West skills plant taxonomy pharmacognosy toxicology e.g. Kew-IMPLAD-Guy’s model create a NETWORK of Chinese medicinal authentication resources relevant to Western & international needs long-term success of Chinese Medicine on the world stage We look forward to collaborating more widely…. Xie Xie

  48. Acknowledgements China IMPLAD: Xie Chen, Zhong Zhong Other: Mr Zhou (Anhui), Mr Wang, Mr Liu (Sichuan), Mr Yu (Jilin), local TCM officials, farmers, traders and practitioners UK RBG Kew: Elaine Porter, Sasha Barrow, Georgina Pearman, Andrew McRobb, Geoff Kite, Melanie Howes Other: Yu Hongwen

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