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

Status
Published
Publication Date
04-Aug-2022
Current Stage
6060 - International Standard published
Due Date
07-Jul-2023
Completion Date
05-Aug-2022
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ISO 23964:2022 - Traditional Chinese medicine — Saposhnikovia divaricata root and rhizome Released:5. 08. 2022
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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
---------------------- Page: 1 ----------------------
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 2022 – All rights reserved
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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

iii
© ISO 2022 – All rights reserved
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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

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 (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).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of 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

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.
© ISO 2022 – All rights reserved
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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.
© ISO 2022 – All rights reserved
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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

© ISO 2022 – All rights reserved
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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
© ISO 2022 – All rights reserved
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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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