ISO/TS 21831:2020

TECHNICAL ISO/TS
SPECIFICATION 21831
First edition
2020-01
Information model of Chinese materia
medica processing
Reference number
©
ISO 2020
© ISO 2020
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ii © ISO 2020 – All rights reserved

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 General . 1
3.2 Characterizing categories . 2
4 Categorial structure . 6
4.1 Overview . 6
4.2 Semantic link . 8
Bibliography .10
Foreword
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iv © ISO 2020 – All rights reserved

Introduction
Chinese materia medica is widely utilized as a part of complementary and alternative medicine
throughout East Asia and western countries. In order to ensure the quality and therapeutic effect of
Chinese medicines, it is important to use a proper manufacturing process of Chinese materia medica.
There are guidelines for processing Chinese materia medica in the Traditional Chinese Medicine
industry, and clinical trials are already available. A large number of relevant trials have been conducted
to assess the function of decoction pieces of Chinese materia medica. However, the descriptions of
processing in reports tend to be insufficient for the interpretation of heterogeneity among trials, often
causing difficulties for data synthesis in meta-analyses. This arises from two reasons: firstly, because
of the lack of use of an appropriate information model of the processing of Chinese materia medica, and
secondly because semantic associations between concepts of Chinese materia medica processing have
yet to be explicitly identified.
In order to address these problems, this document defines the information model within the field of
Chinese materia medica processing.
TECHNICAL SPECIFICATION ISO/TS 21831:2020(E)
Information model of Chinese materia medica processing
1 Scope
This document specifies an information model within the field of Chinese materia medica processing. It
defines a set of domain constraints of sanctioned characteristics, each composed of a relationship and
an applicable information model.
This model aims at representing the concepts applicable to Chinese materia medica processing in the
making of decoction pieces.
This document is not applicable to Japanese traditional Kampo medicine.
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 http:// www .electropedia .org/
3.1 General
3.1.1
concept
internal conception of some thing; general notion or idea of some thing
[SOURCE: ISO/TS 18876-2:2003, 3.1.3]
3.1.2
entity
any concrete or abstract thing of interest
3.1.3
relationship
association between two or more entities (3.1.2) indicating the purpose or type of association
Note 1 to entry: Can also be known as an association when the information model is based upon object classes.
3.1.4
information model
graphical and textual representation of entities (3.1.2) and the relationships (3.1.3) between them
Note 1 to entry: Can also be known as a data model, a conceptual data model, a logical data model, an entity
relationship model, an object class diagram, or a database definition.
[SOURCE: ISO/IEC 19763-12:2015, 4.2.24]
3.2 Characterizing categories
3.2.1
traditional Chinese medicine
TCM
traditional medicine that originated in China, and is characterized by holism and treatment based on
pattern identification/syndrome differentiation
[SOURCE: ISO/TS 17948:2014, 2.2]
3.2.2
Chinese materia medica
CMM
medicinal parts of medicinal plants, animals, and minerals after preliminary processing (3.2.4), which
are used as raw materials in Chinese medicines
Note 1 to entry: This refers to the raw materials used to make decoction pieces.
[SOURCE: ISO 18668-1:2016, 3.2]
Note 2 to entry: Preliminary processing can include washing and drying. Large and bulking items can also be cut
into smaller pieces or shorter lengths.
3.2.3
decoction piece
prescription medicine processed from Chinese materia medica (3.2.2) under the direction of traditional
Chinese medicine (3.2.1) and processing (3.2.4) methods for Chinese medicines, which can be directly
used in clinical practice or the production of prepared medicines
3.2.4
processing
physical or chemical technique of converting Chinese materia medica (3.2.2) into decoction pieces
(3.2.3) based on the theory of pharmacology of traditional Chinese medicine (3.2.1), the nature of Chinese
materia medica (3.2.30), the need for dispensing, preparation (3.2.19) and clinical application
Note 1 to entry: This definition is taken from Reference [24].
3.2.5
toxicity
ability of a substance to produce an adverse effect upon a living organism
[SOURCE: ISO 472:2013, 2.767]
3.2.6
effectiveness
accuracy and completeness with which users achieve specified goals
[SOURCE: ISO/TS 20282-2:2013, 4.7]
3.2.7
adjuvant material
substance added during processing (3.2.4) in order to enhance the therapeutic usefulness of
pharmaceutical herbal medicament treatment
Note 1 to entry: Adjuvant material is different from excipient material. The latter is usually used to produce pills
or tablets, inseparable from tablets, etc. But the solid adjuvant material is discarded after processing.
[SOURCE: ISO/TS 18062:2016, 3.4, modified — Note to entry has been modified.]
2 © ISO 2020 – All rights reserved

3.2.8
channel tropism
meridian tropism
orientation of the medicinal action according to the meridian/channel on which the therapeutic action
is manifested
Note 1 to entry: This definition is taken from Reference [20].
3.2.9
moisture content
amount of water contained in decoction pieces (3.2.3) after processing (3.2.4)
Note 1 to entry: General moisture content of CMM and decoction shall be controlled between 7 % and 13 %.
Note 2 to entry: This definition is taken from Reference [22].
3.2.10
ash content
basic purity (3.2.12) indicator for the quality control of decoction pieces (3.2.3)
Note 1 to entry: Ash is present in the residue weight of decoction pieces left after incineration at high temperature
(500℃ to 600℃).
Note 2 to entry: Ash content including physiological ash and acid incompatibility ash.
EXAMPLE The total ash content of GLYCYRRHIZAE RADIX ET RHIZOMA (Gancao) is not more than 7 %. The
acid incompatibility ash content is not more than 2 %.
Note 3 to entry: This definition is taken from Reference [22].
3.2.11
texture
shape, size, colour, quality of the herb and decoction pieces (3.2.3)
Note 1 to entry: This definition is taken from Reference [23].
3.2.12
purity
quota of the impurities or non-medicinal parts in processed Chinese materia medica (3.2.2)
Note 1 to entry: This definition is taken from Reference [22].
3.2.13
pressure
exertion of force upon a surface
3.2.14
decoction ingredient
chemical components including bioactive or therapeutic agents, and other invalid chemical constituents
in decoction pieces (3.2.3) which stem from botanical medicine (3.2.16), mineral medicine (3.2.17) and
animal medicine (3.2.15)
Note 1 to entry: This definition is taken from Reference [25].
3.2.15
animal medicine
Chinese materia medica (3.2.2) derived from animals
Note 1 to entry: Terrestrial animals, insects, marine creatures, organs, tissue, secretion, discharge, glue, solid
particles formed in the organs, shell can also be used as CMM.
EXAMPLE PHERETIMA (Dilong), BOVISC ALCULUS (Niuhuang).
Note 2 to entry: This definition is taken from Reference [18].
3.2.16
botanical medicine
Chinese materia medica (3.2.2) derived from plants
Note 1 to entry: Whole plant, plant part, tissue, resin or gum can be used as CMM.
Note 2 to entry: This definition is taken from Reference [18].
3.2.17
mineral medicine
Chinese materia medica (3.2.2) derived from a solid, naturally occurring inorganic substance
Note 1 to entry: These medicines can be original or created after simple processing of the mineral product.
Note 2 to entry: This definition is taken from Reference [18].
3.2.18
seeds medicine
Chinese materia medica (3.2.2) derived from mature seeds
Note 1 to entry: Seeds medicine is a subcategory of botanical medicine.
EXAMPLE Peach kernel (PERSICAE SEMEN, Taoren), bitter apricot seed (ARMENIACAE SEMEN AMARUM,
Ku xingren).
Note 2 to entry: This definition is taken from Reference [24].
3.2.19
preparation
action or process of preparing or being prepared for use or consideration
EXAMPLE Calcining, frying.
Note 1 to entry: This definition is taken from Reference [24].
3.2.20
stir-frying
procedure where cleaned and cut decoction pieces (3.2.3), are put into a pre-heated container and
heated continuously while stirring or rotating it
Note 1 to entry: This is a procedure used for processing decoction pieces which have been cut and cleaned.
Note 2 to entry: This process can be with or without adjuvants.
Note 3 to entry: This process is classified into plain-frying or frying with solid adjuvants.
Note 4 to entry: This definition is taken from Reference [24].
3.2.21
cutting
operating procedure of softening Chinese materia medica (3.2.2) after c
...