ISO/TR 23021:2018
(Main)Traditional Chinese medicine — Controlled vocabulary on Japanese Kampo crude drugs
Traditional Chinese medicine — Controlled vocabulary on Japanese Kampo crude drugs
This document gives names for crude drugs used in Kampo formulae with concepts (or definitions) that are designated by the names to ensure safety and to facilitate international trade, including source materials and intermediate products/materials. Those names are aligned with the names for both the intermediate products and the medicinal products that are manufactured in accordance with the definitions and/or designs. This document is applicable to crude drugs "as concepts (or definitions)" used in Kampo medicine. This document excludes the following: — individual manufactured drug names for medicinal products "as things" derived from crude drugs; — medicinal materials (Materia Medica) "as things", or traditional medicines that are not regulated by the Japanese Pharmacopoeia or the related official documents published by the Medicinal Regulatory Agency, the Ministry of Health Labour and Welfare of Japan.
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TECHNICAL ISO/TR
REPORT 23021
First edition
2018-08
Traditional Chinese medicine —
Controlled vocabulary on Japanese
Kampo crude drugs
Reference number
©
ISO 2018
© ISO 2018
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 2018 – All rights reserved
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Conformance . 3
5 Abbreviated terms and symbols . 3
6 Preparation of terminological entries . 4
6.1 Organization of preparatory work . 4
6.1.1 Target group and subject delimitation . 4
6.1.2 Types of referencing source . 4
6.1.3 Evaluation of reference sources . 4
6.2 Recording terminological data . 4
6.2.1 Terminological entries . 4
6.2.2 Backbone concepts . 4
6.2.3 Administrative information . 6
6.2.4 Physicochemical identification . 6
6.2.5 Systematic order . 6
7 Controlled vocabulary on Japanese Kampo crude drugs . 6
7.1 General . 6
7.2 Term list . 7
Annex A (informative) Sample of physicochemical identification in Japanese Pharmacopoeia .44
Bibliography .46
Alphabetical Index A: Latin names of crude drugs .48
Alphabetical Index B: English names of crude drugs .51
Alphabetical Index C: Scientific names of original natural materials used for crude drugs .54
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. 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. 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 on 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 the following
URL: www .iso .org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
iv © ISO 2018 – All rights reserved
Introduction
Kampo medicine is the traditional medicine of Japan. Ancient Chinese medicine was first introduced to
Japan around 1 600 years ago, but Kampo medicine has developed independently from ancient Chinese
medicine for the past 500 years. In the medication therapy of Kampo medicine, physicians prescribe
medicinal products based on Kampo formulae that consist of various crude drugs based on Kampo
medicinal theory.
The crude drugs in this document are the natural materials that are used as components of Kampo
formulae in Japan. They are defined and regulated by the Japanese Pharmacopoeia and the Japanese
official addendum for crude drug standards. The crude drugs used in Japan are often different from
those used in China and other countries with respect to origins, part(s) of interest, and processing. In
addition, there are large numbers of synonyms and homonyms among names for crude drugs.
This situation could not be ignored during the standardization of contemporary terminology for medicinal
products or the latest drug information management. Rather, it is feasible that such a situation could also
be considered in international standardization. However, this has yet to be achieved in ISO/TC 249.
Therefore, this document gives the terms of crude drugs used in Japanese Kampo medicine with
contemporary methodologies specified in ISO deliverables and conforming to related standards on
drug information management to avoid market distortion and health hazards.
Using controlled vocabulary for crude drugs with accurate expressions according to definitions
of national pharmacopoeias and related documents published by national Medicines Regulatory
Authorities is a fundamental step in ensuring health safety, both in medical care and in trade. The
information provided by this document is expected to decrease barriers to trade.
Any formulae or traditional medicines that are not controlled by the Japanese Pharmacopoeia and
related official documents published by the Medicinal Regulatory Authorities in Japan are out of the
scope of this document.
TECHNICAL REPORT ISO/TR 23021:2018(E)
Traditional Chinese medicine — Controlled vocabulary on
Japanese Kampo crude drugs
1 Scope
This document gives names for crude drugs used in Kampo formulae with concepts (or definitions)
that are designated by the names to ensure safety and to facilitate international trade, including source
materials and intermediate products/materials. Those names are aligned with the names for both
the intermediate products and the medicinal products that are manufactured in accordance with the
definitions and/or designs. This document is applicable to crude drugs “as concepts (or definitions)”
used in Kampo medicine.
This document excludes the following:
— individual manufactured drug names for medicinal products “as things” derived from crude drugs;
— medicinal materials (Materia Medica) “as things”, or traditional medicines that are not regulated
by the Japanese Pharmacopoeia or the related official documents published by the Medicinal
Regulatory Agency, the Ministry of Health Labour and Welfare of Japan.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
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 https: //www .electropedia .org/
3.1
natural material
naturally presenting object or substance in the real world, part of which is utilized for a medicinal purpose
Note 1 to entry: It is from plants, animals, or minerals, and usually expressed as a Latin name (scientific name).
3.2
part of interest
medicinal part
part of a natural material (3.1) that is utilizable for crude drug (3.3)
3.3
crude drug
natural medicine used as a component of a Kampo formula (3.6) and defined or authorized in the
[23] [24]
Japanese Pharmacopeia and the Japanese official addendum for crude drug standards
Note 1 to entry: Crude drug (3.3) that was derived from a plant corresponds to HB-SNM (herbal medicament
made of single natural material) in Reference [18].
Note 2 to entry: A crude drug (3.3) has several medicament forms, including pieces for decoction, cut crude drug,
or powdered crude drug in the Japanese Pharmacopeia.
3.4
origin
definition of crude drug (3.3), including the name of the natural material (3.1) and the part of interest
(3.2) for medicinal use
3.5
kampo medicine
traditional medicine that has been developed in Japan
Note 1 to entry: Ancient Chinese medicine was introduced to Japan around 1 600 years ago; since around 500
years ago, Japanese Kampo medicine has developed independently of China.
3.6
kampo formula
combination of crude drugs (3.3) defined or authorized by the Medicines Regulatory Agency in Japan
3.7
Latin name of crude drug
Latin name of crude drug defined or authorized in Japanese Pharmacopeia and Japanese official
addendum for crude drug standards
Note 1 to entry: The Latin name of crude drug defined in each pharmacopoeia is sometimes different, although
its origin has the same scientific name as the natural material (3.1) and part of interest (3.2). Usually, it is based
on the combination of Latin genus names of the natural material and its part of interest.
Note 2 to entry: The symbol is added as superscript to the Latin name of crude drugs used in Kampo medicine
(3.5) in this document to distinguish crude drugs in Kampo medicine from those in the Chinese Materia Medica in
Reference [19], 2.1. For example, the Latin name BUPLEURI RADIX (7.2.29) is defined as the root of Bupleurum
falcatum Linné (Umbelliferae), but the Latin name Bupleuri Radix in Chinese Materia Medica in Reference [19],
3.86, is defined as the root of Bupleurum chinense DC. or Bupleurum scorzonerifolium Willd. See 5.3.
3.8
English name of crude drug
English name of the crude drug defined or authorized in the Japanese Pharmacopeia and the Japanese
official addendum for crude drug standards
Note 1 to entry: Usually, the English name of the crude drug is based on the combination of English genus names
of the natural material (3.1) and its part of interest (3.2).
Note 2 to entry: The symbol has been added as superscript to the English names of crude drugs used in
Kampo medicine (3.5) in this document for the same reason as in. See 5.3.
3.9
Japanese name of crude drug
Japanese name of the crude drug defined or authorized in the Japanese Pharmacopeia and the Japanese
official addendum for
...
TECHNICAL ISO/TR
REPORT 23021
First edition
2018-08
Traditional Chinese medicine —
Controlled vocabulary on Japanese
Kampo crude drugs
Reference number
©
ISO 2018
© ISO 2018
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 2018 – All rights reserved
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Conformance . 3
5 Abbreviated terms and symbols . 3
6 Preparation of terminological entries . 4
6.1 Organization of preparatory work . 4
6.1.1 Target group and subject delimitation . 4
6.1.2 Types of referencing source . 4
6.1.3 Evaluation of reference sources . 4
6.2 Recording terminological data . 4
6.2.1 Terminological entries . 4
6.2.2 Backbone concepts . 4
6.2.3 Administrative information . 6
6.2.4 Physicochemical identification . 6
6.2.5 Systematic order . 6
7 Controlled vocabulary on Japanese Kampo crude drugs . 6
7.1 General . 6
7.2 Term list . 7
Annex A (informative) Sample of physicochemical identification in Japanese Pharmacopoeia .44
Bibliography .46
Alphabetical Index A: Latin names of crude drugs .48
Alphabetical Index B: English names of crude drugs .51
Alphabetical Index C: Scientific names of original natural materials used for crude drugs .54
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. 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. 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 on 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 the following
URL: www .iso .org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
iv © ISO 2018 – All rights reserved
Introduction
Kampo medicine is the traditional medicine of Japan. Ancient Chinese medicine was first introduced to
Japan around 1 600 years ago, but Kampo medicine has developed independently from ancient Chinese
medicine for the past 500 years. In the medication therapy of Kampo medicine, physicians prescribe
medicinal products based on Kampo formulae that consist of various crude drugs based on Kampo
medicinal theory.
The crude drugs in this document are the natural materials that are used as components of Kampo
formulae in Japan. They are defined and regulated by the Japanese Pharmacopoeia and the Japanese
official addendum for crude drug standards. The crude drugs used in Japan are often different from
those used in China and other countries with respect to origins, part(s) of interest, and processing. In
addition, there are large numbers of synonyms and homonyms among names for crude drugs.
This situation could not be ignored during the standardization of contemporary terminology for medicinal
products or the latest drug information management. Rather, it is feasible that such a situation could also
be considered in international standardization. However, this has yet to be achieved in ISO/TC 249.
Therefore, this document gives the terms of crude drugs used in Japanese Kampo medicine with
contemporary methodologies specified in ISO deliverables and conforming to related standards on
drug information management to avoid market distortion and health hazards.
Using controlled vocabulary for crude drugs with accurate expressions according to definitions
of national pharmacopoeias and related documents published by national Medicines Regulatory
Authorities is a fundamental step in ensuring health safety, both in medical care and in trade. The
information provided by this document is expected to decrease barriers to trade.
Any formulae or traditional medicines that are not controlled by the Japanese Pharmacopoeia and
related official documents published by the Medicinal Regulatory Authorities in Japan are out of the
scope of this document.
TECHNICAL REPORT ISO/TR 23021:2018(E)
Traditional Chinese medicine — Controlled vocabulary on
Japanese Kampo crude drugs
1 Scope
This document gives names for crude drugs used in Kampo formulae with concepts (or definitions)
that are designated by the names to ensure safety and to facilitate international trade, including source
materials and intermediate products/materials. Those names are aligned with the names for both
the intermediate products and the medicinal products that are manufactured in accordance with the
definitions and/or designs. This document is applicable to crude drugs “as concepts (or definitions)”
used in Kampo medicine.
This document excludes the following:
— individual manufactured drug names for medicinal products “as things” derived from crude drugs;
— medicinal materials (Materia Medica) “as things”, or traditional medicines that are not regulated
by the Japanese Pharmacopoeia or the related official documents published by the Medicinal
Regulatory Agency, the Ministry of Health Labour and Welfare of Japan.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
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 https: //www .electropedia .org/
3.1
natural material
naturally presenting object or substance in the real world, part of which is utilized for a medicinal purpose
Note 1 to entry: It is from plants, animals, or minerals, and usually expressed as a Latin name (scientific name).
3.2
part of interest
medicinal part
part of a natural material (3.1) that is utilizable for crude drug (3.3)
3.3
crude drug
natural medicine used as a component of a Kampo formula (3.6) and defined or authorized in the
[23] [24]
Japanese Pharmacopeia and the Japanese official addendum for crude drug standards
Note 1 to entry: Crude drug (3.3) that was derived from a plant corresponds to HB-SNM (herbal medicament
made of single natural material) in Reference [18].
Note 2 to entry: A crude drug (3.3) has several medicament forms, including pieces for decoction, cut crude drug,
or powdered crude drug in the Japanese Pharmacopeia.
3.4
origin
definition of crude drug (3.3), including the name of the natural material (3.1) and the part of interest
(3.2) for medicinal use
3.5
kampo medicine
traditional medicine that has been developed in Japan
Note 1 to entry: Ancient Chinese medicine was introduced to Japan around 1 600 years ago; since around 500
years ago, Japanese Kampo medicine has developed independently of China.
3.6
kampo formula
combination of crude drugs (3.3) defined or authorized by the Medicines Regulatory Agency in Japan
3.7
Latin name of crude drug
Latin name of crude drug defined or authorized in Japanese Pharmacopeia and Japanese official
addendum for crude drug standards
Note 1 to entry: The Latin name of crude drug defined in each pharmacopoeia is sometimes different, although
its origin has the same scientific name as the natural material (3.1) and part of interest (3.2). Usually, it is based
on the combination of Latin genus names of the natural material and its part of interest.
Note 2 to entry: The symbol is added as superscript to the Latin name of crude drugs used in Kampo medicine
(3.5) in this document to distinguish crude drugs in Kampo medicine from those in the Chinese Materia Medica in
Reference [19], 2.1. For example, the Latin name BUPLEURI RADIX (7.2.29) is defined as the root of Bupleurum
falcatum Linné (Umbelliferae), but the Latin name Bupleuri Radix in Chinese Materia Medica in Reference [19],
3.86, is defined as the root of Bupleurum chinense DC. or Bupleurum scorzonerifolium Willd. See 5.3.
3.8
English name of crude drug
English name of the crude drug defined or authorized in the Japanese Pharmacopeia and the Japanese
official addendum for crude drug standards
Note 1 to entry: Usually, the English name of the crude drug is based on the combination of English genus names
of the natural material (3.1) and its part of interest (3.2).
Note 2 to entry: The symbol has been added as superscript to the English names of crude drugs used in
Kampo medicine (3.5) in this document for the same reason as in. See 5.3.
3.9
Japanese name of crude drug
Japanese name of the crude drug defined or authorized in the Japanese Pharmacopeia and the Japanese
official addendum for
...
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