© 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


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.


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)


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


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


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

http://www.speciesfungorum.org/Names/Names.asp?strGenus=Ganoderma


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


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


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

http://www.countdown2010.net/

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


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


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


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 ???

© copyright 2010 all rights reserved, gp-tcm consortium. quality control wp1 braga, portugal, july...

Documents

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phaeoporus lucidus curtis

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ganoderma lucidum curtis

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