ISO 8959:2024
(Main)Traditional Chinese medicine — Eucommia ulmoides stem bark
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
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
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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
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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
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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
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