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.
Titre manque
General Information
Standards Content (Sample)
TECHNICAL ISO/TR
REPORT 23021
First edition
2018-08
Traditional Chinese medicine —
Controlled vocabulary on Japanese
Kampo crude drugs
Reference number
ISO/TR 23021:2018(E)
©
ISO 2018
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ISO/TR 23021:2018(E)
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ISO/TR 23021:2018(E)
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
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ISO/TR 23021:2018(E)
Foreword
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bodies (ISO member bodies). The work of preparing International Standards is normally carried out
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electrotechnical standardization.
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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
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on the ISO list of patent declarations received. www .iso .org/patents
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This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
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ISO/TR 23021:2018(E)
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.
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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.
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ISO/TR 23021:2018(E)
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 crude drug standards
Note 1 to entry: The Japanese name is described by a string of Japanese phonetic letters in Katakana
(Reference [16], Kana411) and/or the Japanese ideographic letters Kanji (Reference [16], Hani 500).
Note 2 to entry: The symbol has been added as a superscript to strings of Kanji letters in this document;
firstly to distinguish Kanji letters from simplified Chinese characters (簡体字) (Reference [16], Hans 501) or
traditional Chinese characters (繁体字) (Reference [16], Hant 502) due to their similar shapes and because most
of these letters can be converted to each other. This situation proposes another reason that “convertible strings”
[6] [6]
of names can define different crude drugs. Homonym or polyseme can cause health hazards. See 5.3.
3.10
identifier of crude drug
unique code which designates a particular crude drug (3.3)
[26]
Note 1 to entry: The identifier of crude drug is defined by the substance code for drug management in Japan
[27]
or by the substance code in Japan standard commodity classification (JSCC) .
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ISO/TR 23021:2018(E)
4 Conformance
The medicinal products based on Kampo formulae use crude drugs, whose origins are correctly
identified in the Japanese Pharmacopoeia or in the Japanese official addendum for crude drug standards.
In Japan, manufacturers are obligated to express the names of crude drugs of the medicinal product
based on Japanese Kampo formulae using Latin, English, or Japanese names defined by the Japanese
Pharmacopoeia or the Japanese official addendum for crude drug standards.
See also 6.2.1, 6.2.3, and 7.1.
5 Abbreviated terms and symbols
5.1
JP
[23]
Japanese Pharmacopoeia . This abbreviation is used for referencing the source in 7.2.1 to 7.2.130.
NOTE The superscript symbol (5.3) does not refer to . See from 3.7 to 3.9 and 5.3.
5.2
Non-JP
[24]
The Japanese standards for non-Pharmacopoeial crude drugs (non-JP crude drug standards) . This
abbreviation is used for referencing the source in 7.2.1 to 7.2.130.
5.3
The superscript symbol is added to a string of letters that expresses the crude drugs in Kampo
medicine (3.5) except for those in Japanese Katakana (Reference [16], Kana411) in this document.
See 3.7, 3.8 and 3.9.
NOTE 1 The superscript symbol has three efficacies: 1) it focuses attention on recognizing the meaning;
[6]
2) prohibits conversions of the letters; and 3) helps to distinguish between homonyms and polysemes .
NOTE 2 Such superscript symbols are very useful in distinguishing the names defined by the Medicines
[12][13][14]
Regulatory Authorities in each nation or area. The reasons are illustrated in examples below.
NOTE 3 The superscript symbol is not the abbreviation of but of . It means
the addenda and related official documents published by the Japanese Medicines Regulatory Authorities including
Japanese Pharmacopoeia. See 3.7 to 3.9.
EXAMPLE 1 The meaning (or the designated concept) of 漢字 is not equivalent to that of 汉字 in Chinese,
although the letters in the two strings can be converted to each other.
EXAMPLE 2 ANGELICAE RADIX , Japanese Angelica Root , and 当帰 are defined as the root of
Angelica acutiloba Kitagawa or Angelica acutiloba Kitagawa var. sugiyamae Hikino (Umbelliferae), usually after
being passed through hot water (7.2.9). That is different from 当归 in Chinese, which is defined as the root of
Angelica sinensis (Oliv.) Diels in Reference [19], 3.38.
EXAMPLE 3 BUPLEURI RADIX , Bupleurum Root and, 柴胡 are defined as the root of Bupleurum
falcatum Linné (Umbelliferae) (7.2.29). That is different from 柴胡 in Chinese, which is defined as the root of
Bupleurum chinense DC. or Bupleurum scorzonerifolium Willd. In Reference [19], 3.86.
EXAMPLE 4 SINOMENI CAULIS ET RHIZOMA , Sinomenium Stem and Rhizome , and 防已 are
defined as the climbing stem and rhizome of Sinomenium acutum Rehder et Wilson (Menispermaceae), usually
cut transversely (7.2.117). This is different from 防己 in Chinese, which is defined as dried root of Stephania
tetrandra in Reference [19], 3.452.
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ISO/TR 23021:2018(E)
6 Preparation of terminological entries
6.1 Organization of preparatory work
6.1.1 Target group and subject delimitation
The target group was defined according to References [12] and [18]. The target domain or subjects are
specified in the Introduction. Consequently, the constraints or preconditions described in 6.2.1, 6.2.3,
and 6.2.4 are applied.
6.1.2 Types of referencing source
JP and Non-JP are developed by the Ministry of Health, Labour, and Welfare, the Medicines Regulatory
Agency in Japan, who define the standards for crude drugs from several viewpoints, including
pharmacognosy, physiology, and chemistry. Therefore, their types of reference sources come under the
following categories as specified in Reference [11], 4.3.5.2:
a) legal documents;
b) standards;
c) documents generally recognized by the scientific community.
6.1.3 Evaluation of reference sources
According to the descriptions in 6.1.2, the referencing sources of this document has been evaluated as
follows:
a) the terminological data are the most reliable;
b) the author is the authority on medicine regulation in Japan;
c) the terminological data in the document is widely accepted in Japan and in the world.
6.2 Recording terminological data
6.2.1 Terminological entries
Terminological entries include the following in conformance with international terminology standards:
— Latin name of crude drug;
— English name of crude drug;
[16]
— Japanese name of crude drug respectively expressed both in Katakana letters (Kana 411 ) and in
[16]
Kanji letters (Hani 500 );
— String of Latin letters for expression of Japanese pronunciation;
— Crude drug defined by the scientific name(s) of the natural material(s) and the medicinal part with
processing, as in Reference [18], Figure 1;
— Identification of the referencing source;
— Identifier of crude drug surrogated with the substance code for drug management in Japan.
6.2.2 Backbone concepts
[18]
The backbone concepts for representation of crude drugs are based on ISO/TS 18062 . Its concept
diagram is illustrated in Figure 1.
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ISO/TR 23021:2018(E)
The first three items specified in 6.2.1 respectively correspond to the “name in Latin”, “name in English”,
and “name in Country Language” within “Official Name” in the figure. The three sub-items in the fifth
item of 6.2.1 respectively correspond to “Source”, “Origin”, and “Scientific Name.”
[18]
Therefore, the data items specified in this doument are very feasible and conform to ISO/TS 18062
[12][13][14]
and IDMPs .
There are no vernacular names; in other words, all names defined in 7.2 in this document are controlled
vocabulary.
Key
single Herbal Medicament minimal concepts for representation of regulated design or identification of
pharmaceutical products or medicinal products made of a single herbal substance
Origin characterizing category, which contains the designations of “medicinal plants” as the
characterizing concepts that are required in the single Herbal Medicament
PartOfInterest characterizing category, which contains the designations of “part(s) of interest” as the
characterizing concepts that are required in the single Herbal Medicament
Processing characterizing category which contains the designations of “processing methods” as the
characterizing concepts, that are required in the single Herbal Medicament
[18]
Figure 1 — Conceptual representation for a single herbal medicament (crude drug)
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ISO/TR 23021:2018(E)
6.2.3 Administrative information
This document itself does not require any conformity because it is a Technical Report. Japanese
jurisdiction uses the following policy.
— The organization responsible for the terminological data of the crude drugs used in Kampo medicine
and the Kampo formulae is The Minister of Health, Labour and Welfare of Japan, as the Medicines
Regulatory Agency.
— Japanese names of crude drugs are expressed in the Japanese language with Japanese script. The
codes are in accordance with ISO 639-1, ISO 3166-1 and ISO 15924.
[3]
— The Japanese names of crude drugs with the phonetic letters in Katakana (Kana 411 ) are the
canonical names in the JP and non-JP.
— Identifier for crude drugs are defined in the substance code for drug management in Japan and are
regulated by The Minister of Health, Labour, and Welfare of Japan.
The identifier of crude drug is a unique code that designates a certain crude drug as a certain substance.
[26]
could be used, such as the Substance ID specified in IDMPs.
In this sense, this substance code
However, at the present time, the Medicines Regulatory Agency in Japan has not declared this to be
acceptable.
6.2.4 Physicochemical identification
JP and Non-JP define the standards of crude drugs by several viewpoints, including term-related data,
pharmacognosy, and physicochemical characteristics. See Annex A for examples.
Pharmacognosy includes (i) the appearance of the natural material to identify species, and (ii) several
identification methods to identify component(s) or constituent(s). Thin-Layer Chromatography (TLC)
and High Performance Liquid Chromatography (HPLC) are recognized as relevant methods. (iii) Gene
analysis is an optional method for some substances when identification is difficult.
NOTE Microscopic morphology is also a reliable method for source materials. JP usually defines the spot of
marker compound in TLC for each crude drug as the minimal requirement in the market. However, in actuality,
the manufacturers in Japan make additional efforts by themselves.
Additionally, the JP and Non-JP define the limits of foreign substances, wrong species, wrong medicinal
parts, pesticides, heavy metals, soil, and so on.
6.2.5 Systematic order
Systemic order is arranged according to the Latin names of crude drugs.
7 Controlled vocabulary on Japanese Kampo crude drugs
7.1 General
Taking into account 6.2.1 and 6.2.3, the terms defined in 7.2 can be utilized correctly and meaningfully.
Again, the Latin name of crude drug is defined in pharmacopoeias, but is not the scientific name of the
natural material. The Japanese name of the crude drug in ideographic expression, i.e. Kanji expression,
[16]
utilizes the letters in accordance with Hani 500 . The Latin name, English name, and Japanese name
of crude drugs in Kampo medicine are expressed with the superscript symbol , if needed.
Japanese jurisdiction uses the intention of designating the crude drugs defined in JP and non-JP and
their definitions presented in 7.2 based on the designators.
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ISO/TR 23021:2018(E)
7.2 Term list
7.2.1
Latin name: ACHYRANTHIS RADIX
English name: Achyranthes Root
Japanese name in Katakana: ゴシツ
Japanese name in Kanji: 牛膝
Japanese pronunciation: Goshitsu
Definition: The dried root of Achyranthes fauriei Leveillé et Vaniot or
Achyranthes bidentata Blume (Amaranthaceae)
Referencing source: JP
Substance code: 120098
7.2.2
Latin name: ADEPS SUILLUS
English name: Lard
Japanese name in Katakana: トンシ
Japanese name in Kanji: 豚脂
Japanese pronunciation: Tonshi
Definition: The fat obtained from Sus scrofa Linné var. domesticus Gray (Suidae)
Referencing source: JP
Substance code: 001455
7.2.3
Latin name: AKEBIAE CAULIS
English name: Akebia Stem
Japanese name in Katakana: モクツウ
Japanese name in Kanji: 木通
Japanese pronunciation: Mokutsu
Definition: The dried climbing stem of Akebia quinata Decaisne or
Akebia trifoliata Koidzumi (Lardizabalaceae), usually cut transversely
Referencing source: JP
Substance code: 120161
7.2.4
Latin name: ALISMATIS TUBER
English name: Alisma Tuber
Japanese name in Katakana: タクシャ
Japanese name in Kanji: 沢瀉
Japanese pronunciation: Takusha
Definition: The dried tuber of Alisma orientale Juzepczuk (Alismataceae),
from which periderm has been usually removed
Referencing source: JP
Substance code: 120125
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7.2.5
Latin name: ALPINIAE OFFICINARI RHIZOMA
English name: Alpinia Officinarum Rhizome
Japanese name in Katakana: リョウキョウ
Japanese name in Kanji: 良姜
Japanese pronunciation: Ryokyo
Definition: The dried rhizome of Alpinia officinarum Hance (Zingiberaceae)
Referencing source: JP
Substance code: 120229
7.2.6
Latin name: AMOMI SEMEN
English name: Amomum Seed
Japanese name in Katakana: シュクシャ
Japanese name in Kanji: 縮砂
Japanese pronunciation: Shukusya
Definition: The dried seed mass of Amomum xanthioides Wallich (Zingiberaceae)
Referencing source: JP
Substance code: 120114
7.2.7
Latin name: ANEMARRHENAE RHIZOMA
English name: Anemarrhena Rhizome
Japanese name in Katakana: チモ
Japanese name in Kanji: 知母
Japanese pronunciation: Chimo
Definition: The dried rhizome of Anemarrhena asphodeloides Bunge (Liliaceae)
Referencing source: JP
Substance code: 120127
7.2.8
Latin name: ANGELICAE DAHURICAE RADIX
English name
...
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