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© Copyright 2010 All Rights Reserved, GP-TCM Consortium. Quality Control WP1 Braga, Portugal, July 2011 Monique S.J. Simmonds on behalf of the many people.

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Presentation on theme: "© Copyright 2010 All Rights Reserved, GP-TCM Consortium. Quality Control WP1 Braga, Portugal, July 2011 Monique S.J. Simmonds on behalf of the many people."— Presentation transcript:

1 © Copyright 2010 All Rights Reserved, GP-TCM Consortium. 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 © Copyright 2010 All Rights Reserved, GP-TCM Consortium. 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 © Copyright 2010 All Rights Reserved, GP-TCM Consortium. 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 © Copyright 2010 All Rights Reserved, GP-TCM Consortium. ‘Liu Wei Di Huang Wan ’ Rhizoma Alismatis’, ‘Fructus Corni’, ‘Rhizoma Dioscoreae’, ‘Cortex Moutan’, ‘Poria’, ‘Radix Rehmanniae Praeparata’

5 © Copyright 2010 All Rights Reserved, GP-TCM Consortium. Scientific name used in the Chinese Pharmacopoeia (English eds.) 4, 5 Taxonomically ‘accepted’ scientific name 1,2,3 Part used in TCM (note f) Pharmaceutical names 4, 5 Chinese and Pin Yin names 4;5 Scientific synonyms 1;2;3 The following 6 species are those used in the TCM formula: "Liu Wei Di Huang Wan" Alisma orientalis (Sam.) Juzep. 4, 5 Alisma orientale (Samuelsson) Juzepczuk 1; note h tuber/rhizomeRhizoma Alismatis 4 ; Alismatis Rhizoma 5 泽泻 'Ze Xie' or 'Zexie' Alisma plantago-aquatica Linnaeus var. orientale Samuelsson 1 ; A. plantago-aquatica subsp. orientale (Samuelsson) Samuelsson 1 Cornus officinalis Sieb. et Zucc. 4, 5 Cornus officinalis Siebold & Zuccarini 1 ripe fruit (sometimes processed with yellow rice wine) (note a) Fructus Corni 4 ; Corni Fructus 5 山茱萸 'Shan Zhu Yu' or 'Shanzhuyu' Macrocarpium officinale (Siebold & Zuccarini) Nakai 1 ; Cornus officinalis var. koreana Kitam. 2 Dioscorea opposita Thunb. 4, 5 Dioscorea polystachya Turczaninow 1; note c tuber/rhizomeRhizoma Dioscoreae 4 ; Dioscoreae Rhizoma 5 山药 'Shan Yao' or 'Shanyao' Dioscorea batatas Decaisne 1 ; D. decaisneana Carrière 1 ; D. doryphora Hance 1 ; D. potaninii Prain & Burkill 1 ; D. rosthornii Diels 1 ; D. swinhoei Rolfe 1 ; Dioscorea batatas f. clavata Makino 2 ; D.batatas f. daikok Makino 2 ; D. batatas f. flabellata Makino 2 ; D. batatas f. rakuda Makino 2 ; D. batatas f. tsukune Makino 2 ; D. cayennensis var. pseudobatatas Hauman 2 ; D. pseudobatatas (Hauman) Herter 2 Paeonia suffruticosa Andr. 4, 5 Paeonia ostii T. Hong & J. X. Zhang 1; note d rootbarkCortex Moutan 4 ; Moutan Cortex 5 牡丹皮 'Mu Dan Pi' or 'Mudanpi' Paeonia ostii var. lishizhenii B. A. Shen 1 ; P. ostii subsp. lishizhenii (B. A. Shen) B. A. Shen 1 ; P. suffruticosa Andrews subsp. ostii (T. Hong & J. X. Zhang) Halda 1 Poria cocos (Schw.) Wolf. 4, 5 Wolfiporia extensa (Peck) Ginns 3 sclerotium (storage organ and non- reproductive part) Poria 4; 5 茯苓 'Fu Ling' or 'Fuling' Daedalea extensa Peck; Macrohyporia cocos (Schwein.) I. Johans. & Ryvarden 3 ; Macrohyporia extensa (Peck) Ginns & J. Lowe 3 ; Pachyma cocos (Schwein.) Fr. 3 ; Poria cocos F.A. Wolf 3 ; Sclerotium cocos Schwein. 3 ; Wolfiporia cocos (F.A. Wolf) Ryvarden & Gilb. 3 Rehmannia glutinosa Libosch. 4, 5 Rehmannia glutinosa (Gaertner) Liboschitz ex Fischer & C. A. Meyer 1 processed tuber/rhizome note g Radix Rehmanniae Praeparata 4 ; Rehmanniae Radix Praeparata 5 熟地黄 'Shu Di Huang' or 'Shudihuang' Digitalis glutinosa Gaertner 1 ; Rehmannia chinensis Liboschitz ex Fischer & C. A. Meyer 1 ; R. glutinosa var. hemsleyana Diels 1 ; R. glutinosa var. huechingensis Chao & Shih 1 ; R. glutinosa f. huechingensis (Chao & Shih) P. G. Hsiao 1 ; R. glutinosa f. purpurea Matsuda 1

6 © Copyright 2010 All Rights Reserved, GP-TCM Consortium. Ganoderma lucidum (Leyss. ex Fr.) Karst. 4, 5 ? Ganoderma lucidum (Curtis) P. Karst. 3;Ganoderma Warning: the true identity of the fungus used in TCM and known by this name or its Chinese or pharmaceutical names is in doubt. See note ‘i’. sporophore (reproductive part) Ganoderma 4; 5 灵芝 'Ling Zhi' or ‘Lingzhi’ Possible synonyms note i : Boletus lucidus Curtis 3 ; Agarico-igniarium trulla Paulet 3 ; Agaricus lignosus Lam. 3 ; A. pseudoboletus Jacq. 3 ; Boletus castaneus Weber 3 ; B. crustatus J.J. Planer 3 ; B. dimidiatus Thunb. 3 ; B. flabelliformis Leyss. 3 ; B. laccatus Timm 3 ; B. lucidus Curtis 3 ; B. ramulosum var. flabelliformis (Leyss.) J.F. Gmel. 3 ; B. rugosus Jacq. 3 ; B. supinus var. castaneus (Weber) J.F. Gmel. 3 ; B. verniceus Brot. 3 ; B. vernicosus Bergeret 3 ; Fomes japonicus (Fr.) Sacc. 3 ; Fomes lucidus (Curtis) Cooke 3 ; Ganoderma japonicum (Fr.) Sawada 3 ; G. mongolicum Pilát 3 ; G. nitens Lázaro Ibiza 3 ; G. ostreatum Lázaro Ibiza 3 ; G. pseudoboletus (Jacq.) Murrill 3 ; Grifola lucida (Curtis) Gray 3 ; Phaeoporus lucidus (Curtis) J. Schröt. 3 ; Placodes lucidus (Curtis) Quél. 3 ; Polyporus japonicus Fr. 3 ; P. laccatus (Timm) Pers. 3 ; P. laccatus (Timm) Pers. subsp. laccatus 3 ; P. lucidus (Curtis) Fr. 3 ; P. lucidus var. japonicus (Fr.) Cleland & Cheel 3, Scindalma japonicum (Fr.) Kuntze 3

7 © Copyright 2010 All Rights Reserved, GP-TCM Consortium. 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

8 Marker compound

9 Finding the profile of “active” molecules in plant

10 © Copyright 2010 All Rights Reserved, GP-TCM Consortium. 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

11

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

13 © Copyright 2010 All Rights Reserved, GP-TCM Consortium. 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

14 ‘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

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

16 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

17 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)

18 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

19 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

20 © Copyright 2010 All Rights Reserved, GP-TCM Consortium. 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

21 © Copyright 2010 All Rights Reserved, GP-TCM Consortium. 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

22 © Copyright 2010 All Rights Reserved, GP-TCM Consortium. 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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