ISO/TS 23303:2020

TECHNICAL ISO/TS
SPECIFICATION 23303
First edition
2020-01
Health informatics — Categorial
structure for Chinese materia medica
products manufacturing process
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 . 5
4.1 Overview . 5
4.2 Semantic link . 6
4.2.1 Use . 6
4.2.2 Is processed by . 6
4.2.3 Produce . 6
4.2.4 Precede . 7
4.2.5 Affect . 7
4.2.6 Result in . 7
4.2.7 Enhance . 7
4.2.8 Reduce . . . 7
Bibliography . 8
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.
The manufacturing process of traditional Chinese materia medica products is a complicated control
system engineering including equipment, technology and quality. The manufacturing process proposed
in this document is a part of traditional Chinese materia medica control system engineering.
There are many types of manufacturing process, but systematic terminology definitions and semantic
links did not exist, which often caused difficulties for production management and metadata analysis.
This arises from two reasons: firstly, a wide variety of dosage forms and manufacturing process are
difficult to classify accurately; secondly, the categorial structure of processing Chinese materia medica
has not been published.
This document provides a categorial structure which could solve these problems and improve the
scientific level of production management of Chinese medicines.
TECHNICAL SPECIFICATION ISO/TS 23303:2020(E)
Health informatics — Categorial structure for Chinese
materia medica products manufacturing process
1 Scope
This document specifies the whole manufacturing process of Chinese materia medica products by
defining a set of domain constraints of sanctioned characteristics, each composed of a relationship
and an applicable categorial structure. It includes three process categories: processing, extracting and
preparation.
This document is not applicable to Japanese traditional KAMPO medicinal products.
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
unit of knowledge created by a unique combination of characteristics (3.1.4)
Note 1 to entry: A concept can have one or more names. It can be represented using one or more terms, pictures,
icons or sounds.
3.1.2
category
division of sets of entities regarded as having particular shared characteristics (3.1.4)
EXAMPLE Freeze drying, spray drying and all other drying share characteristics particular to the
category drying.
Note 1 to entry: Categories can be more or less general. Where one category is subsumed by another, there is a
relation asserted to obtain a hierarchy between the more specific or subsumed category and the more general or
subsuming category. For example, parenteral route is more general than intravenous route.
3.1.3
categorial structure
minimal set of domain constraints for representing concept systems in a subject field
3.1.4
characteristic
abstraction of a property, of an object or of a set of objects
EXAMPLE Fever is a characteristic symptom of flu.
Note 1 to entry: Characteristics are used for describing concepts and for differentiating categories.
3.1.5
semantic link
formal representation of a directed associative relation or partitive relation between two concepts (3.1.1)
Note 1 to entry: This includes all relations except the generic relation.
Note 2 to entry: A semantic link always has an inverse, i.e. another semantic link with the opposite direction.
[SOURCE: ISO 17115:2007, 2.2.3, modified — Note 3 to entry was removed.]
3.1.6
Chinese medicines
substance or combination of substances used under the guidance of traditional Chinese medicine
theory for medical care and the prevention and treatment of disease
Note 1 to entry: This includes Chinese materia medica, decoction pieces, Granule Forms of Individual Medicinals
for Prescriptions (GFIMP), and Chinese Patent Medicines (CPM).
[SOURCE: ISO 20333:2017, 3.1]
3.1.7
manufacturing
complete process of production through all processing stages, including final packaging, and all
materials involved in the process
3.1.8
product
thing or material manufactured from all processing stages of manufacturing (3.1.7)
Note 1 to entry: Chinese materia medica manufacturing products include, but are not limited to, decoction pieces,
extraction (includes two categories: monomer and mixture), Chinese patent medecine.
3.2 Characterizing categories
3.2.1
Chinese materia medica
CMM
medicinal parts of medicinal plants, animals, and minerals used as raw materials in Chinese medicines
(3.1.6) after preliminary processing (3.2.6)
Note 1 to entry: This refers to the raw materials used to make decoction pieces.
[SOURCE: ISO 18668-1:2016, 3.2, modified]
Note 2 to entry: Preliminary processing refers to some operations in the process of harvesting Chinese materia
medica, such as removing sundries, sorting, packing, etc. for better storage and management.
3.2.2
origin
location of Chinese materia medica (3.2.1)
EXAMPLE The places where the plants were grown, Dangshen origin: ShanXi.
3.2.3
variety
class of Chinese materia medica divided according to its own characteristics (3.1.4)
EXAMPLE Liquorice has variety types, such as raw liquorice and moxibustion liquorice.
Note 1 to entry: Decoction pieces can be divided into pieces, segments, silk and slices according to different
shape.
2 © ISO 2020 – All rights reserved

3.2.4
decoction piece
prescription medicinal processed from Chinese materia medica (3.2.1) under the guidance of traditional
Chinese medicine and processing methods (3.2.7) for Chinese medicines (3.1.6)
[SOURCE: ISO 18668-1:2016, 3.3, modified]
3.2.5
description
shape, size, colour, odour, etc. of the decoction piece (3.2.4) and adjuvant material (3.2.8)
3.2.6
processing
action of performing, for pharmaceutical purposes, a series of mechanical or chemical operations to
change or preserve Chinese materia medica (3.2.1) according to Chinese medicine theory, the nature of
herbs, and the medical and pharmaceutical needs
Note 1 to entry: Chinese materia medica can be processed using, for example, water or fire processing. Adjuvant
material, instruments, heat can also be used to produce decoction pieces. Through processing, the effectiveness
of Chinese materia medica can be enhanced and the toxicity and odour of Chinese materia medica can be reduced.
3.2.7
processing method
method used to change the nature of Chinese materia medica (3.2.1)
EXAMPLE Calcine and roast are two methods used to process Chinese materia medica.
3.2.8
adjuvant material
substance added during the processing (3.2.6) of Chinese materia medica (3.2.1) to enhance the
therapeutic usefulness of pharmaceutical herbal treatment
[SOURCE: ISO/TS 18062:2016, modified]
3.2.9
purifying
process of eliminating impurities and removing non-medical parts
3.2.10
effectiveness
therapeutic results of a processing method (3.2.7)
EXAMPLE Ephedra has improved effectiveness in antitussive, expectorant and other effects through the
processing of honey.
3.2.11
toxicity
degree to which a Chinese materia medica (3.2.1) can caus
...