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Transcript of © Copyright 2010 All Rights Reserved, GP-TCM Consortium. Quality Control WP1 Braga, Portugal, July...
© 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
© 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.
© 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)
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‘Liu Wei Di Huang Wan’ Rhizoma Alismatis’, ‘Fructus Corni’, ‘Rhizoma Dioscoreae’, ‘Cortex Moutan’, ‘Poria’, ‘Radix Rehmanniae Praeparata’
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Scientific name used in the Chinese Pharmacopoeia (English eds.) 4, 5
Taxonomically ‘accepted’ scientific name1,2,3
Part used in TCM (note f)
Pharmaceutical names4, 5
Chinese and Pin Yin names4;5
Scientific synonyms1;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) Juzepczuk1; note
h
tuber/rhizome Rhizoma Alismatis4; Alismatis Rhizoma5
泽泻 'Ze Xie' or 'Zexie'
Alisma plantago-aquatica Linnaeus var. orientale Samuelsson1; A. plantago-aquatica subsp. orientale (Samuelsson) Samuelsson1
Cornus officinalis Sieb. et Zucc. 4, 5 Cornus officinalis Siebold & Zuccarini1
ripe fruit (sometimes processed with yellow rice wine) (note
a)
Fructus Corni4; Corni Fructus5
山茱萸 'Shan Zhu Yu' or 'Shanzhuyu'
Macrocarpium officinale (Siebold & Zuccarini) Nakai1; Cornus officinalis var. koreana Kitam.2
Dioscorea opposita Thunb. 4, 5 Dioscorea polystachya Turczaninow1; note c
tuber/rhizome Rhizoma Dioscoreae4;Dioscoreae Rhizoma5
山药 'Shan Yao' or 'Shanyao'
Dioscorea batatas Decaisne1; D. decaisneana Carrière1; D. doryphora Hance1; D. potaninii Prain & Burkill1; D. rosthornii Diels1; D. swinhoei Rolfe1; Dioscorea batatas f. clavata Makino2; D.batatas f. daikok Makino2; D. batatas f. flabellata Makino2; D. batatas f. rakuda Makino2; D. batatas f. tsukune Makino2; D. cayennensis var. pseudobatatas Hauman2; D. pseudobatatas (Hauman) Herter2
Paeonia suffruticosa Andr. 4, 5 Paeonia ostii T. Hong & J. X. Zhang1; note d
rootbark Cortex Moutan4; Moutan Cortex5
牡丹皮 'Mu Dan Pi' or 'Mudanpi'
Paeonia ostii var. lishizhenii B. A. Shen1; P. ostii subsp. lishizhenii (B. A. Shen) B. A. Shen1; P. suffruticosa Andrews subsp. ostii (T. Hong & J. X. Zhang) Halda1
Poria cocos (Schw.) Wolf. 4, 5 Wolfiporia extensa (Peck) Ginns3
sclerotium (storage organ and non-reproductive part)
Poria4; 5
茯苓 'Fu Ling' or 'Fuling'
Daedalea extensa Peck; Macrohyporia cocos (Schwein.) I. Johans. & Ryvarden3; Macrohyporia extensa (Peck) Ginns & J. Lowe3; Pachyma cocos (Schwein.) Fr. 3; Poria cocos F.A. Wolf3; 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. Meyer1
processed tuber/rhizomenote g
Radix Rehmanniae Praeparata4;Rehmanniae Radix Praeparata5
熟地黄 'Shu Di Huang' or 'Shudihuang'
Digitalis glutinosa Gaertner1; Rehmannia chinensis Liboschitz ex Fischer & C. A. Meyer1; R. glutinosa var. hemsleyana Diels1; R. glutinosa var. huechingensis Chao & Shih1; R. glutinosa f. huechingensis (Chao & Shih) P. G. Hsiao1; R. glutinosa f. purpurea Matsuda1
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Ganoderma lucidum (Leyss. ex Fr.) Karst. 4, 5
? Ganoderma lucidum (Curtis) P. Karst.3; 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)
Ganoderma4; 5 灵芝 'Ling Zhi' or ‘Lingzhi’
Possible synonymsnote i : Boletus lucidus Curtis3; Agarico-igniarium trulla Paulet3; Agaricus lignosus Lam.3; A. pseudoboletus Jacq.3; Boletus castaneus Weber3; B. crustatus J.J. Planer3; B. dimidiatus Thunb. 3; B. flabelliformis Leyss. 3; B. laccatus Timm3; B. lucidus Curtis3; 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 Bergeret3; Fomes japonicus (Fr.) Sacc. 3; Fomes lucidus (Curtis) Cooke3; Ganoderma japonicum (Fr.) Sawada3; G. mongolicum Pilát3; G. nitens Lázaro Ibiza3; G. ostreatum Lázaro Ibiza3; G. pseudoboletus (Jacq.) Murrill3; Grifola lucida (Curtis) Gray3; 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. laccatus3; P. lucidus (Curtis) Fr. 3; P. lucidus var. japonicus (Fr.) Cleland & Cheel3, Scindalma japonicum (Fr.) Kuntze3
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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
Surface chemistry (LC)
Sub
stru
ctur
e (M
S2)
Mas
s:ch
arge
(MS1)
Marker compound
Surface chemistry (LC)
Sub
stru
ctur
e (M
S2)
Mas
s:ch
arge
(MS1)
Finding the profile of “active” molecules in plant
© Copyright 2010 All Rights Reserved, GP-TCM Consortium.
Quality Control Issues relating to quality
Supply of materialExport of material (restrictions on samples being taken out of China: clarity of permits needed)Substitutes /adulterants
12
32 76
3
24
2008-2009
Scatter Plot
Taxonomic compounds
3D representation of LC-MS profile
Active compounds
Kite/Simmonds et al. unpublished
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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
‘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
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
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
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)
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
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
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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
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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
© 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 ???