ISO/TR 23975:2019
(Main)Traditional Chinese medicine — Priority list of single herbal medicines for developing standards
Traditional Chinese medicine — Priority list of single herbal medicines for developing standards
This document provides a reference of single herbal medicines in order of their priority in the development of international standards.
Médecine traditionnelle chinoise — Liste prioritaire de médicaments à base de plantes pour les normes en cours de développement
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TECHNICAL ISO/TR
REPORT 23975
First edition
2019-11
Traditional Chinese medicine —
Priority list of single herbal medicines
for developing standards
Reference number
©
ISO 2019
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principles . 1
5 Technical indexes . 1
5.1 International trading . 1
5.2 Single herbal medicines recorded in pharmacopoeias . 3
5.3 Safety concerns .36
5.4 Single herbal medicine standards published or under development .43
5.5 Endangered species .43
6 Data processing .44
6.1 Expert consultation .44
6.2 Data statistics .44
7 Single herbal medicines in order of priority .44
Annex A (informative) Priority list of single herbal medicines ranked from 101 to 366 .50
Bibliography .62
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2019 – All rights reserved
Introduction
Being a significant part of traditional medicine systems and general health services, traditional Chinese
medicine is estimated to be used in over 180 countries and regions around the world. This is reflected
by the statistics cited from the WHO report that there are 4 billion people in the world using herbal
medicines, accounting for 80 % of the total world population. Asia, North America, and Europe are
regarded as the major markets for herbal medicines. Moreover, incomplete Chinese customs statistics
show that the import and export of herbal medicine products in China was worth over 4,7 billion USD in
2015. Therefore, it is very important to develop globally harmonized standards in order to ensure the
safety of consumers. In particular, those herbal medicines which have been reported to cause adverse
drug reactions (ADR) are drawing much attention from national health administrations.
There are a great number of single herbs on the market; for instance, 618 kinds of herbs have been
included in the Pharmacopoeia of the People's Republic of China. Currently, organizations, regions and
countries including ISO, WHO, the European Union, China, Japan, Korea, the USA, the UK and Thailand
are making valuable contributions by developing standards for single herbs. This document presents
a list of single herbal medicines in order of priority for the purposes of developing standards on single
herbs in a scientific and orderly manner. This document can be used as a reference by any organization
wishing to develop standards on single herbal medicines.
The following factors have been considered in setting the priorities:
— the trade volume of each single herbal medicine in the global market;
— whether the herbal medicine is recorded by the Pharmacopoeia of the People's Republic of China, Hong
Kong Chinese Materia Medica Standards, the Japanese Pharmacopoeia, the Korean Pharmacopoeia, the
European Pharmacopoeia, the United States Pharmacopoeia or the Thai Herbal Pharmacopoeia;
— whether there are potential risks from its use;
— whether the herbal medicine is listed in the Convention on International Trade in Endangered
[27]
Species of Wild Fauna and Flora (CITES) ;
— opinions from experts.
TECHNICAL REPORT ISO/TR 23975:2019(E)
Traditional Chinese medicine — Priority list of single
herbal medicines for developing standards
1 Scope
This document provides a reference of single herbal medicines in order of their priority in the
development of international standards.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
No terms and definitions are listed in this document.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
4 Principles
4.1 Herbal medicines which have a large international trading value are listed as high priority.
4.2 Standards of common herbal medicines recorded in the Pharmacopoeia of the People's Republic
of China, Hong Kong Chinese Materia Medica Standards, the Japanese Pharmacopoeia, the Korean
Pharmacopoeia, the European Pharmacopoeia, the United States Pharmacopoeia and the Thai Herbal
Pharmacopoeia are listed as high priority.
4.3 Herbal medicines that have safety concerns, such as those widely reported to cause ADR, are listed
as high priority.
4.4 Single herbal medicines for which there are existing ISO standards are listed as high priority.
4.5 Herbal medicines which are included in CITES are listed as low priority.
5 Technical indexes
5.1 International trading
Table 1 provides information on single herbal medicines which had a large international trading value
in China from 2012 to 2016 (sorted by export value).
Table 1 — The top 30 average export values of single herbal medicines in China from 2012 to 2016
Rank Herbal name Pharmaceu- Chinese English name Average
tical name name export value
(RMB)
1 Panax ginseng root ginseng radix ginseng 126 734 151,80
人参
et rhizoma
2 Lycium barbarum fruit lycii fructus 枸杞子 barbary wolfberry 94 077 843,40
fruit
3 Rehmannia glutinosa root rehmanniae 地黄 rehmannia root 44 922 908,20
radix
4 Codonopsis pilosula root/Co- codonopsis 党参 tangshen 41 610 730,40
donopsis pilosula var. modesta radix
root/Codonopsis tangshen root
5 Atractylodes macrocephala atractylo- 白术 largehead atracty- 38 199 927
rhizome dis macro- lodes rhizome
cephalae
rhizoma
6 Poria cocos sclerotium poria 茯苓 Indian bread 36 716 994,40
7 Chrysanthemum morifolium chrysan- 菊花 chrysanthemum flower 34 606 367
capitulum themi flos
8 Ligusticum chuanxiong rhizome chuanxiong 川芎 Szechwan lovage 31 187 826,60
rhizoma rhizome
9 Paeonia lactiflora root paeoniae 白芍 white peony root 27 389 650,20
radix alba
10 Panax notoginseng root and notoginseng 三七 sanchi 25 725 161,60
rhizome radix et rhi-
zoma
11 Pinellia ternata tuber pinelliae 半夏 pinellia tuber 24 263 936,40
rhizoma
12 Astragalus membranaceus var. astragli radix milkvetch root 22 314 041,40
黄芪
mongholicus root/Astragalus
membranaceus root
13 Glycyrrhiza glabra root and glycyrrhizae 甘草 licorice root 21 464 347,60
rhizome/Glycyrrhiza inflata radix et rhi-
root and rhizome/Glycyrrhiza zoma
glabra root and rhizome
14 Angelica sinensis root angelicae sin-当归 Chinese angelica 21 158 784,20
ensis radix
15 Eucommia ulmoides stem bark eucommiae 杜仲 eucommia bark 18 636 687
cortex
16 Panax quinquefolium root panacis 西洋参 American ginseng 15 863 902
quinquefolii
radix
17 Cordyceps sinensis stroma cordyceps Chinese caterpillar 13 309 846,20
冬虫夏草
fungus
18 Cervus nippon antler/Cervus cervi cornu 鹿茸 deer horn 12 191 913
elaphus antler pantotri-
chum
19 Scutellaria baicalensis root scutellariae 黄芩 baical skullcap root 9 314 610,60
radix
NOTE 1 Data from China Chamber of Commerce for Import and Export of Medicines and Health Products (CCCMHPIE).
NOTE 2 Deer horn is a kind of animal material and opium poppy seed is not recorded by the Pharmacopoeia of the People's
Republic of China, therefore these data will not be counted in the final result.
NOTE 3 Export value of herbal medicine from other countries, if any, will be complemented.
2 © ISO 2019 – All rights reserved
Table 1 (continued)
Rank Herbal name Pharmaceu- Chinese English name Average
tical name name export value
(RMB)
20 Rheum palmatum root and rhi- rhei radix et rhubarb 7 318 400,40
大黄
zome/Rheum tanguticum root rhizoma
and rhizome/Rheum officinale
root and rhizome
21 Papaver somniferum seed papaveris 罂粟子 opium poppy seed 6 819 266,80
semen
22 Sophora japonica flower and sophorae flos 槐花 pagodatree flower 5 297 235,80
flower bud
23 Fritillaria cirrhosa bulb/Fri- fritillariae 川贝母/浙 tendrilleaf fritillary 4 263 230,20
tillaria unibracteata bulb/ cirrhosae 贝母 bulb/thunberg fritil-
Fritillaria przewalskii bulb/Fri- bulbus/ lary bulb
tillaria delavayi bulb/Fritillaria fritillariae
taipaiensis bulb/Fritillaria uni- thunbergii
bracteata var. wabuensis bulb/ bulbus
Fritillaria thunbergii bulb
24 Coptis chinensis rhizome/Cop- coptidis 黄连 golden thread 4 172 511,20
tis deltoidea rhizome/Coptis rhizoma
teeta rhizome
25 Adenophora tetraphylla root/ adenophorae 南/北沙参 fourleaf ladybell root/ 3 240 574,80
Glehnia littoralis root radix/glehni- coastal glehnia root
ae radix
26 Ephedra sinica stem/Ephedra ephedrae ephedra 2 995 217,80
麻黄
intermedia stem/Ephedra equi- herba
setina stem
27 Curcuma longa rhizome curcumae 姜黄 turmeric 2 667 216,40
longae rhi-
zoma
28 Gastrodia elata tuber gastrodiae 天麻 tall gastrodia tuber 2 239 951,60
rhiz
...
TECHNICAL ISO/TR
REPORT 23975
First edition
2019-11
Traditional Chinese medicine —
Priority list of single herbal medicines
for developing standards
Reference number
©
ISO 2019
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principles . 1
5 Technical indexes . 1
5.1 International trading . 1
5.2 Single herbal medicines recorded in pharmacopoeias . 3
5.3 Safety concerns .36
5.4 Single herbal medicine standards published or under development .43
5.5 Endangered species .43
6 Data processing .44
6.1 Expert consultation .44
6.2 Data statistics .44
7 Single herbal medicines in order of priority .44
Annex A (informative) Priority list of single herbal medicines ranked from 101 to 366 .50
Bibliography .62
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2019 – All rights reserved
Introduction
Being a significant part of traditional medicine systems and general health services, traditional Chinese
medicine is estimated to be used in over 180 countries and regions around the world. This is reflected
by the statistics cited from the WHO report that there are 4 billion people in the world using herbal
medicines, accounting for 80 % of the total world population. Asia, North America, and Europe are
regarded as the major markets for herbal medicines. Moreover, incomplete Chinese customs statistics
show that the import and export of herbal medicine products in China was worth over 4,7 billion USD in
2015. Therefore, it is very important to develop globally harmonized standards in order to ensure the
safety of consumers. In particular, those herbal medicines which have been reported to cause adverse
drug reactions (ADR) are drawing much attention from national health administrations.
There are a great number of single herbs on the market; for instance, 618 kinds of herbs have been
included in the Pharmacopoeia of the People's Republic of China. Currently, organizations, regions and
countries including ISO, WHO, the European Union, China, Japan, Korea, the USA, the UK and Thailand
are making valuable contributions by developing standards for single herbs. This document presents
a list of single herbal medicines in order of priority for the purposes of developing standards on single
herbs in a scientific and orderly manner. This document can be used as a reference by any organization
wishing to develop standards on single herbal medicines.
The following factors have been considered in setting the priorities:
— the trade volume of each single herbal medicine in the global market;
— whether the herbal medicine is recorded by the Pharmacopoeia of the People's Republic of China, Hong
Kong Chinese Materia Medica Standards, the Japanese Pharmacopoeia, the Korean Pharmacopoeia, the
European Pharmacopoeia, the United States Pharmacopoeia or the Thai Herbal Pharmacopoeia;
— whether there are potential risks from its use;
— whether the herbal medicine is listed in the Convention on International Trade in Endangered
[27]
Species of Wild Fauna and Flora (CITES) ;
— opinions from experts.
TECHNICAL REPORT ISO/TR 23975:2019(E)
Traditional Chinese medicine — Priority list of single
herbal medicines for developing standards
1 Scope
This document provides a reference of single herbal medicines in order of their priority in the
development of international standards.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
No terms and definitions are listed in this document.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
4 Principles
4.1 Herbal medicines which have a large international trading value are listed as high priority.
4.2 Standards of common herbal medicines recorded in the Pharmacopoeia of the People's Republic
of China, Hong Kong Chinese Materia Medica Standards, the Japanese Pharmacopoeia, the Korean
Pharmacopoeia, the European Pharmacopoeia, the United States Pharmacopoeia and the Thai Herbal
Pharmacopoeia are listed as high priority.
4.3 Herbal medicines that have safety concerns, such as those widely reported to cause ADR, are listed
as high priority.
4.4 Single herbal medicines for which there are existing ISO standards are listed as high priority.
4.5 Herbal medicines which are included in CITES are listed as low priority.
5 Technical indexes
5.1 International trading
Table 1 provides information on single herbal medicines which had a large international trading value
in China from 2012 to 2016 (sorted by export value).
Table 1 — The top 30 average export values of single herbal medicines in China from 2012 to 2016
Rank Herbal name Pharmaceu- Chinese English name Average
tical name name export value
(RMB)
1 Panax ginseng root ginseng radix ginseng 126 734 151,80
人参
et rhizoma
2 Lycium barbarum fruit lycii fructus 枸杞子 barbary wolfberry 94 077 843,40
fruit
3 Rehmannia glutinosa root rehmanniae 地黄 rehmannia root 44 922 908,20
radix
4 Codonopsis pilosula root/Co- codonopsis 党参 tangshen 41 610 730,40
donopsis pilosula var. modesta radix
root/Codonopsis tangshen root
5 Atractylodes macrocephala atractylo- 白术 largehead atracty- 38 199 927
rhizome dis macro- lodes rhizome
cephalae
rhizoma
6 Poria cocos sclerotium poria 茯苓 Indian bread 36 716 994,40
7 Chrysanthemum morifolium chrysan- 菊花 chrysanthemum flower 34 606 367
capitulum themi flos
8 Ligusticum chuanxiong rhizome chuanxiong 川芎 Szechwan lovage 31 187 826,60
rhizoma rhizome
9 Paeonia lactiflora root paeoniae 白芍 white peony root 27 389 650,20
radix alba
10 Panax notoginseng root and notoginseng 三七 sanchi 25 725 161,60
rhizome radix et rhi-
zoma
11 Pinellia ternata tuber pinelliae 半夏 pinellia tuber 24 263 936,40
rhizoma
12 Astragalus membranaceus var. astragli radix milkvetch root 22 314 041,40
黄芪
mongholicus root/Astragalus
membranaceus root
13 Glycyrrhiza glabra root and glycyrrhizae 甘草 licorice root 21 464 347,60
rhizome/Glycyrrhiza inflata radix et rhi-
root and rhizome/Glycyrrhiza zoma
glabra root and rhizome
14 Angelica sinensis root angelicae sin-当归 Chinese angelica 21 158 784,20
ensis radix
15 Eucommia ulmoides stem bark eucommiae 杜仲 eucommia bark 18 636 687
cortex
16 Panax quinquefolium root panacis 西洋参 American ginseng 15 863 902
quinquefolii
radix
17 Cordyceps sinensis stroma cordyceps Chinese caterpillar 13 309 846,20
冬虫夏草
fungus
18 Cervus nippon antler/Cervus cervi cornu 鹿茸 deer horn 12 191 913
elaphus antler pantotri-
chum
19 Scutellaria baicalensis root scutellariae 黄芩 baical skullcap root 9 314 610,60
radix
NOTE 1 Data from China Chamber of Commerce for Import and Export of Medicines and Health Products (CCCMHPIE).
NOTE 2 Deer horn is a kind of animal material and opium poppy seed is not recorded by the Pharmacopoeia of the People's
Republic of China, therefore these data will not be counted in the final result.
NOTE 3 Export value of herbal medicine from other countries, if any, will be complemented.
2 © ISO 2019 – All rights reserved
Table 1 (continued)
Rank Herbal name Pharmaceu- Chinese English name Average
tical name name export value
(RMB)
20 Rheum palmatum root and rhi- rhei radix et rhubarb 7 318 400,40
大黄
zome/Rheum tanguticum root rhizoma
and rhizome/Rheum officinale
root and rhizome
21 Papaver somniferum seed papaveris 罂粟子 opium poppy seed 6 819 266,80
semen
22 Sophora japonica flower and sophorae flos 槐花 pagodatree flower 5 297 235,80
flower bud
23 Fritillaria cirrhosa bulb/Fri- fritillariae 川贝母/浙 tendrilleaf fritillary 4 263 230,20
tillaria unibracteata bulb/ cirrhosae 贝母 bulb/thunberg fritil-
Fritillaria przewalskii bulb/Fri- bulbus/ lary bulb
tillaria delavayi bulb/Fritillaria fritillariae
taipaiensis bulb/Fritillaria uni- thunbergii
bracteata var. wabuensis bulb/ bulbus
Fritillaria thunbergii bulb
24 Coptis chinensis rhizome/Cop- coptidis 黄连 golden thread 4 172 511,20
tis deltoidea rhizome/Coptis rhizoma
teeta rhizome
25 Adenophora tetraphylla root/ adenophorae 南/北沙参 fourleaf ladybell root/ 3 240 574,80
Glehnia littoralis root radix/glehni- coastal glehnia root
ae radix
26 Ephedra sinica stem/Ephedra ephedrae ephedra 2 995 217,80
麻黄
intermedia stem/Ephedra equi- herba
setina stem
27 Curcuma longa rhizome curcumae 姜黄 turmeric 2 667 216,40
longae rhi-
zoma
28 Gastrodia elata tuber gastrodiae 天麻 tall gastrodia tuber 2 239 951,60
rhiz
...
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