Traditional Chinese medicine — Eucommia ulmoides stem bark

This document specifies the minimum requirements and test methods for Eucommia ulmoides stem bark. It is applicable to Eucommia ulmoides stem bark that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and raw decoction pieces. It is not applicable to processed decoction pieces of Eucommia ulmoides stem bark.

Médecine traditionnelle chinoise — Écorce d'Eucommia ulmoides

General Information

Status
Published
Publication Date
22-Aug-2024
Current Stage
6060 - International Standard published
Start Date
23-Aug-2024
Due Date
24-Nov-2024
Completion Date
23-Aug-2024
Ref Project

Buy Standard

Standard
ISO 8959:2024 - Traditional Chinese medicine — Eucommia ulmoides stem bark Released:23. 08. 2024
English language
16 pages
sale 15% off
Preview
sale 15% off
Preview

Standards Content (Sample)


International
Standard
ISO 8959
First edition
Traditional Chinese medicine —
2024-08
Eucommia ulmoides stem bark
Médecine traditionnelle chinoise — Écorce d'Eucommia
ulmoides
Reference number
© ISO 2024
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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Descriptions . 2
5 Requirements . 2
5.1 General characteristics .2
5.2 Macroscopic characteristics .3
5.3 Microscopic characteristics .3
5.3.1 Transverse section . . .3
5.3.2 Powder .3
5.4 Moisture .4
5.5 Total ash .4
5.6 Acid-insoluble ash .4
5.7 Thin-layer chromatogram .5
5.8 Ethanol-soluble extractives .5
5.9 Content of marker compound(s) .5
5.10 Heavy metals .5
5.11 Pesticide residues .5
5.12 Sulfur dioxide residues . .5
6 Sampling . 5
7 Test methods . 5
7.1 Macroscopic identification .5
7.2 Determination of moisture .5
7.3 Determination of total ash .5
7.4 Determination of acid-insoluble ash .5
7.5 Thin-layer chromatographic identification .5
7.6 Determination of ethanol-soluble extractives .6
7.7 Determination of marker compound(s).6
7.8 Determination of heavy metals .6
7.9 Determination of pesticide residues .6
7.10 Sulfur dioxide residues . .6
8 Test report . 6
9 Packaging, storage and transportation . 6
10 Marking and labelling . 6
Annex A (informative) Thin-layer chromatographic (TLC) identification . 8
Annex B (informative) Determination of marker compound(s) by HPLC-UV .10
Annex C (informative) National and regional requirements for Eucommia ulmoides stem bark . 14
Bibliography .16

iii
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
Introduction
Eucommia ulmoides stem bark has the effects of nourishing the liver and kidneys and strengthening bones.
It is recorded in Compendium of Materia Medica and Sheng Nong’s herbal classic, and is clinically used in
the treatment of hypertension, chronic kidney disease, arthritis and other diseases. Various commodity
specifications of Eucommia ulmoides stem bark, including its medicinal materials, decoction pieces and
extracts, are widely traded in China, the Republic of Korea, Japan, Malaysia, Vietnam, Singapore, Thailand,
Canada and the United States of America. Although Eucommia ulmoides stem bark has been included in
several national pharmacopoeias and regional standards, the requirements differ. In addition, there are
many problems with Eucommia ulmoides stem bark products on the market, such as mixed use of non-
medicinal parts and irregular processing, which can lead to a decline in the quality of this medicinal herb.
Therefore, it is necessary to establish a unified International Standard to guarantee the quality and safety of
Eucommia ulmoides stem bark.
As national implementation can 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
International Standard ISO 8959:2024(en)
Traditional Chinese medicine — Eucommia ulmoides stem bark
1 Scope
This document specifies the minimum requirements and test methods for Eucommia ulmoides stem bark.
It is applicable to Eucommia ulmoides stem bark that is sold and used as natural medicines in international
trade, including Chinese materia medica (whole medicinal materials) and raw decoction pieces.
It is not applicable to processed decoction pieces of Eucommia ulmoides stem bark.
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 sta
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.