ISO 13615

Traditional Chinese medicine — Atractylodes macrocephala rhizome

This document specifies minimum requirements and test methods for Atractylodes macrocephala rhizome that is derived from Atractylodes macrocephala Koidz. It is applicable to Atractylodes macrocephala rhizome that is sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from it.

Médecine traditionnelle chinoise — Rhizome d'Atractylodes macrocephala

General Information

• Status: Not Published
• ICS: 11.120.10 - Medicaments
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249 - Traditional Chinese medicine
• Current Stage: 6000 - International Standard under publication
• Completion Date: 05-Jul-2024

Standards Content (Sample)

FINAL DRAFT
International
Standard
ISO/FDIS 13615
ISO/TC 249
Traditional Chinese medicine —
Secretariat: SAC
Atractylodes macrocephala rhizome
Voting begins on:
Médecine traditionnelle chinoise — Rhizome d'Atractylodes 2024-05-09
macrocephala
Voting terminates on:
2024-07-04
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO/FDIS 13615:2024(en) © ISO 2024

FINAL DRAFT
ISO/FDIS 13615:2024(en)
International
Standard
ISO/FDIS 13615
ISO/TC 249
Traditional Chinese medicine —
Secretariat: SAC
Atractylodes macrocephala rhizome
Voting begins on:
Médecine traditionnelle chinoise — Rhizome d'Atractylodes
macrocephala
Voting terminates on:
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2024
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO/FDIS 13615:2024(en) © ISO 2024

ii
ISO/FDIS 13615:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Descriptions . 2
5 Quality and safety requirements and recommendations . 3
5.1 General characteristics .3
5.2 Morphological features .3
5.2.1 Atractylodes macrocephala rhizome .3
5.2.2 Decoction pieces .3
5.3 Identification .3
5.3.1 Thin-layer chromatography (TLC) identification .3
5.3.2 High performance liquid chromatography (HPLC) identification .3
5.4 Moisture .3
5.5 Total ash .4
5.6 Sulfur dioxide residues . . .4
5.7 Ethanol-soluble extractives .4
5.8 Essential oil.4
5.9 Heavy metals .4
5.10 Pesticide residues .4
6 Sampling . 4
7 Test methods . 4
7.1 Macroscopic identification .4
7.2 Thin-layer chromatography (TLC) identification .4
7.3 High performance liquid chromatography (HPLC) identification.4
7.4 Determination of moisture content .4
7.5 Determination of total ash content .4
7.6 Determination of sulfur dioxide residues content .4
7.7 Determination of ethanol-soluble extractives content .5
7.8 Determination of essential oil content .5
7.9 Determination of heavy metals content .5
7.10 Determination of pesticide residues content .5
8 Test report . 5
9 Packaging, storage and transportation . 5
10 Marking and labelling . 5
Annex A (informative) Thin-layer chromatography (TLC) identification . 6
Annex B (informative) High performance liquid chromatography (HPLC) identification . 8
Annex C (informative) Reference values of national and regional limits .11
Bibliography .12

iii
ISO/FDIS 13615:2024(en)
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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.

iv
ISO/FDIS 13615:2024(en)
Introduction
Atractylodes macrocephala rhizome, the dried rhizome of Atractylodes macrocephala Koidz., is a widely
used herbal medicine in China and many other countries. In traditional Chinese medicine, this herb can
tonify the Spleen-Qi, and is used to treat distension in the abdomen, loose stools, and diarrhoea. Modern
pharmacological studies also demonstrate its great potential in immuno-enhancement and indigestion
treatment. The market, yield, and trade volume of Atractylodes macrocephala rhizome are large and develop
rapidly in recent years.
Atractylodes macrocephala rhizome has been recorded in several pharmacopoeias, including Chinese
[1] [2] [3] [4]
Pharmacopoeia, European Pharmacopoeia, Korean Pharmacopoeia Japanese Pharmacopoeia and
[5]
Hong Kong Chinese Materia Medical Standards. The requirements and specifications in these standards
have differences. Therefore, it is important to develop an International Standard for harmonizing the
existing standards, as well as ensuring the safety and effectiveness of Atractylodes macrocephala rhizome,
which can benefit farmers, consumers, enterprises and governments involved in the cultivation, regulation
and trade of Atractylodes macrocephala rhizome.
As national implementation may differ, national standards bodies are invited to modify the values given in
5.4 and 5.5 in their national standards. Examples of national and regional values are given in Annex C.

v
FINAL DRAFT International Standard ISO/FDIS 13615:2024(en)
Traditional Chinese medicine — Atractylodes
macrocephala rhizome
1 Scope
This document specifies requirements and test methods for Atractylodes macrocephala rhizome that is
derived from Atractylodes macrocephala Koidz.
It is applicable to Atractylodes macrocephala rhizome that is sold and used as a natural medicine in
international trade, including Chinese materia medica (whole
...

ISO/FDIS 13615:2024(E)
ISO/TC 249/WG1
Secretariat: SAC
Date: 2024-03-2604-24
Traditional Chinese medicine — Atractylodes macrocephala rhizome
Médecine traditionnelle chinoise — Rhizome d'Atractylodes macrocephala
FDIS stage
ISO/FDIS 13615:2024(Een)
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication
may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying,
or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO
at the address below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
Fax: [phone]
EmailE-mail: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2024 – All rights reserved
ii
ISO/FDIS 13615:2024(Een)
Contents
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Descriptions . 2
5 Quality and safety requirements and recommendations . 4
5.1 General characteristics . 4
5.2 Morphological features . 4
5.2.1 Atractylodes macrocephala rhizome . 4
5.2.2 Decoction pieces . 4
5.3 Identification . 4
5.3.1 Thin-layer chromatography (TLC) identification . 4
5.3.2 High performance liquid chromatography (HPLC) identification . 4
5.4 Moisture . 4
5.5 Total ash . 4
5.6 Sulfur dioxide residues . 5
5.7 Ethanol-soluble extractives. 5
5.8 Essential oil . 5
5.9 Heavy metals . 5
5.10 Pesticide residues . 5
6 Sampling . 5
7 Test methods . 5
7.1 Macroscopic identification . 5
7.2 Thin-layer chromatography (TLC) identification . 5
7.3 High performance liquid chromatography (HPLC) identification . 5
7.4 Determination of moisture content . 5
7.5 Determination of total ash content . 5
7.6 Determination of sulfur dioxide residues content . 5
7.7 Determination of ethanol-soluble extractives content . 6
7.8 Determination of essential oil content . 6
7.9 Determination of heavy metals content . 6
7.10 Determination of pesticide residues content . 6
8 Test report . 6
9 Packaging, storage and transportation . 6
10 Marking and labelling . 6
Annex A (informative) Thin-layer chromatography (TLC) identification . 8
Annex B (informative) High performance liquid chromatography (HPLC) identification . 11
Annex C (informative) Reference values of national and regional limits . 15
Bibliography . 17

iii
ISO/FDIS 13615:2024(Een)
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights
in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s)
which may be required to implement this document. However, implementers are cautioned that this may not
represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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.
iv © ISO 2024 – All rights reserved
iv
ISO/FDIS 13615:2024(Een)
Introduction
Atractylodes macrocephala rhizome, the dried rhizome of Atractylodes macrocephala Koidz., is a widely used
herbal medicine in China and many other countries. In traditional Chinese medicine, this herb can tonify the
Spleen-Qi, and is used to treat distension in the abdomen, loose stools, and diarrhoea. Modern pharmacological
studies also demonstrate its great potential in immuno-enhancement and indigestion treatment. The market,
yield, and trade volume of Atractylodes macrocephala rhizome are large and develop rapidly in recent years.
Atractylodes macrocephala rhizome has been recorded in several pharmacopoeias, including Chinese
[1[1] ] [2[2] ] [3[3]] [4[4]]
Pharmacopoeia, , European Pharmacopoeia, , Korean Pharmacopoeia Japanese Pharmacopoeia
[5[5] ]
and Hong Kong Chinese Materia Medical Standards. . The requirements and specifications in these
standards have differences. Therefore, it is important to develop an International Standard for harmonizing
the existing standards, as well as ensuring the safety and effectiveness of Atractylodes macrocephala rhizome,
which can benefit farmers, consumers, enterprises and governments involved in the cultivation, regulation
and trade of Atractylodes macrocephala rhizome.
As national implementation may differ, national standards bodies are invited to modify the values given in
5.45.4 and 5.55.5 in their national standards. Examples of national and regional values are given in
Annex CAnnex C.
v
FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 13615:2024(E)

Traditional Chinese medicine- — Atractylodes macrocephala rhizome
1 Scope
This document specifies requirements and test methods for Atractylodes macrocephala rhizome that is
derived from Atractylodes macrocephala Koidz.
It is applicable to Atractylodes macrocephala rhizome that is sold and used as a natural medicine in
international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces
derived from the 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 22590, Traditional Chinese medicine — Determination of sulfur dioxide in natural products by titration
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
Atractylodes macrocephala rhizome
dried rhizome (3.2(3.2)) of Atractylodes macrocephala Koidz in the family of Atractylodes.
3.2
rhizome
creeping rootstalk
main stem of a plant that sends out roots and shoots from its nodes
ISO/FDIS 13615:2024(Een)
4 Descriptions
Figure 1Figure 1 illustrates the structure of Atractylodes macrocephala rhizome. The crude drug is collected
in winter, when the leaves at the lower part of the plant turn yellow and those at the upper part become
fragile,; with soil removed and, it is baked over low heat or dried under the sun; the fibrous roots are removed
to obtain Atractylodes macrocephala rhizome.

a) plant of Atractylodes macrocephala rhizome

b) whole rhizome                                       c) decoction pieces
2 © ISO 2023 – All rights reserved
ISO/FDIS 13615:2024(Een)
a) Plant of Atractylodes macrocephala rhizome

b) Whole rhizome c) Decoction pieces
Key
1 flower
2 foliage
3 wrinkles and grooves
4 warty protrudings
5 dotted oil cavities
6 chrysanthemum-shaped cracks
Figure 1 — Structure of Atractylodes macrocephala rhizome
ISO/FDIS 13615:2024(Een)
...