ISO 23964:2022
(Main)Traditional Chinese medicine — Saposhnikovia divaricata root and rhizome
Traditional Chinese medicine — Saposhnikovia divaricata root and rhizome
This document specifies the quality and safety requirements of Saposhnikovia divaricata root and rhizome derived from the plant of Saposhnikovia divaricata (Turcz.) Schischk. It is applicable to Saposhnikovia divaricata root and rhizome that is sold as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
Médecine traditionnelle chinoise — Racine et rhizome de Saposhnikovia divaricata
General Information
Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 23964
First edition
2022-08
Traditional Chinese medicine —
Saposhnikovia divaricata root and
rhizome
Médecine traditionnelle chinoise — Racine et rhizome de
Saposhnikovia divaricata
Reference number
ISO 23964:2022(E)
© ISO 2022
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ISO 23964:2022(E)
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© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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ISO 23964:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Descriptions . 2
5 Requirements . 3
5.1 General characteristics . 3
5.2 Macroscopic characteristics . 3
5.2.1 Appearance . 3
5.2.2 Sensory identification . 3
5.3 Moisture . 4
5.4 Total ash . 4
5.5 Acid-insoluble ash . 4
5.6 Thin-layer chromatography identification . 4
5.7 Dilute ethanol-soluble extractives . 4
5.8 Content of marker compound . 4
5.9 Heavy metals . 4
5.10 Pesticide residues . 4
5.11 Commercial grades . 4
6 Sampling . 4
7 Test methods . 5
7.1 Macroscopic identification . 5
7.2 Determination of moisture content . 5
7.3 Determination of total ash . 5
7.4 Determination of acid-insoluble ash . 5
7.5 Determination of dilute ethanol-soluble extractives content . 5
7.6 Thin-layer chromatography (TLC) identification . 5
7.7 Determination of maker compound content . 5
7.8 Determination of heavy metals content . 5
7.9 Determination of pesticide residues content . 5
8 Test report . 5
9 Packaging, storage and transportation . 6
10 Marking and labelling . 6
Annex A (informative) Determination of dilute ethanol-soluble extractives .7
Annex B (informative) Thin layer chromatography (TLC) identification.8
Annex C (informative) Determination of Prim-O-glucosylcimifugin and
5-O-methylvisammioside content .10
Annex D (informative) Referenced information of national and regional requirements on
Saposhnikovia divaricata root and rhizome .15
Annex E (informative) Example of traditional grades information of Saposhnikovia
divaricata root and rhizome .16
Bibliography .18
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ISO 23964:2022(E)
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
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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).
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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.
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ISO 23964:2022(E)
Introduction
Saposhnikovia divaricata root and rhizome is the dried root and rhizome of Saposhnikovia divaricata
(Turcz.) Schischk. It was first recorded in the book Divine Farmer’s Classic of Materia Medica, a commonly
used reference material in various countries. Saposhnikovia divaricata root and rhizome has long been
used in traditional Chinese medicine for its multiple therapeutic properties (antipyretic, analgesic,
sedative, anti-inflammatory, anti-allergic and anti-convulsion). It is a highly regarded traditional
Chinese medicine with significant medicinal and economic value around the world. Due to annually
increasing domestic and international demand, cultivated herbs have begun to replace wild herbs on
the market. The markets of Japan, Korea, Germany, and China, amongst others, have a large circulation
of Saposhnikovia divaricata root and rhizome.
Saposhnikovia divaricata root and rhizome is mainly distributed in the northeast China (Inner Mongolia,
Heilongjiang, Liaoning, Jilin), which are the major production areas of China and account for more
than 80 % of national production. It is also planted in Hebei and Shanxi Provinces. The qualities of
Saposhnikovia divaricata root and rhizome from the producing areas differ in their appearance and
chemical contents when comparing cultivated and wild ones. Therefore, the work for identification and
quality evaluation of Saposhnikovia divaricata root and rhizome is highly important.
Although Saposhnikovia divaricata root and rhizome has been recorded in Chinese Pharmacopoeia
(2020 edition), Japanese Pharmacopoeia (17th edition), and Korean Pharmacopoeia (10th edition),
these standards are not harmonized and can be unsuitable for the purpose of international trade of
Saposhnikovia divaricata root and rhizome. Therefore, it is of utmost urgency to standardize the quality
of Saposhnikovia divaricata root and rhizome in the world. This action will benefit consumers (patients),
farmers, enterprises and companies related to the planting, management and trade of Saposhnikovia
divaricata root and rhizome.
As national implementation can differ, National Standards Bodies are invited to modify the values given
in 5.3, 5.4, 5.5 and 5.7 in their national standards. Examples of national and regional values are given in
Annex D.
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INTERNATIONAL STANDARD ISO 23964:2022(E)
Traditional Chinese medicine — Saposhnikovia divaricata
root and rhizome
1 Scope
This document specifies the quality and safety requirements of Saposhnikovia divaricata root and
rhizome derived from the plant of Saposhnikovia divaricata (Turcz.) Schischk.
It is applicable to Saposhnikovia divaricata root and rhizome that is sold as natural medicine in
international trade, including Chinese materia medica (whole medicinal materials) and decoction
pieces derived from this plant.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 18664, Traditional Chinese Medicine — Determination of heavy metals in herbal medicines used in
Traditional Chinese Medicine
ISO 21371, Traditional Chinese medicine — Labelling requirements of products intended for oral or topical
use
ISO 22217, Traditional Chinese medicine —Storage requirements for raw materials and decoction pieces
ISO 22258, Traditional Chinese medicine — Determination of pesticide residues in natural products by gas
chromatography
ISO 23723, Traditional Chinese medicine — General requirements for herbal raw material and materia
medica
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology 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
wild Saposhnikovia divaricata root and rhizome
dried root and rhizome of Saposhnikovia divaricata (Turcz.) Schischk that grows naturally without
cultivation
3.2
cultivated Saposhnikovia divaricata root and rhizome
dried root and rhizome of Saposhnikovia divaricata (Turcz.) Schischk that are artificially cultivated
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ISO 23964:2022(E)
4 Descriptions
In this document, Saposhnikovia divaricata root and rhizome is the dried root and rhizome of
Saposhnikovia divaricata (Turcz.) Schischk. in the family of Apiaceae as shown in Figure 1.
a) plant of Saposhnikovia divaricata (Turcz.) Schischk.
b) wild Saposhnikovia divaricata root and rhizome c) cultivated Saposhnikovia divaricata root and
rhizome
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ISO 23964:2022(E)
d) transverse section of wild herb e) transverse section of cultivated herb
Key
1 leaf
2 stem
3 tap root
4 lateral root
5 inflorescence
6 seed
7 hair-like remains of leaf sheath
8 dense crosswise wrinkles
9 longitudinal wrinkles
10 lacunae
Figure 1 — Structure of Saposhnikovia divaricata and Saposhnikovia divaricata root and
rhizome
5 Requirements
5.1 General characteristics
The following requirements should be met before the sampling.
a) Saposhnikovia divaricata root and rhizome should be clean and free from f
...
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