ISO 4154:2022
(Main)Traditional Chinese medicine — Sinomenium acutum stem
Traditional Chinese medicine — Sinomenium acutum stem
This document specifies the minimum quality and safety requirements of Sinomenium acutum stem [the dried lianoid stem of Sinomenium acutum (Thunb.) Rehd. et Wils. and Sinomenium acutum (Thunb.) Rehd. et Wils. var. cinereum Rehd. et Wils.]. This document applies to Sinomenium acutum stem that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from these plants.
Médecine traditionnelle chinoise — Tige de Sinomenium acutum
General Information
Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 4154
First edition
2022-05
Traditional Chinese medicine —
Sinomenium acutum stem
Médecine traditionnelle chinoise — Tige de Sinomenium acutum
Reference number
ISO 4154:2022(E)
© ISO 2022
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ISO 4154:2022(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 4154:2022(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 Morphological features of Sinomenium acutum stem . 3
5.3 Microscopic identification . 3
5.3.1 Transverse section . . . 3
5.3.2 Powder . 3
5.4 Thin-layer chromatogram identification . 3
5.5 Moisture . 3
5.6 Total ash . 3
5.7 Acid-insoluble ash . 3
5.8 Heavy metals . 4
5.9 Pesticide residues . 4
5.10 Marker compound . 4
6 Sampling . 4
7 Test methods . 4
7.1 Macroscopic identification . 4
7.2 Microscopic identification . 4
7.3 Thin-layer chromatogram identification . 4
7.4 Determination of moisture content . 4
7.5 Determination of total ash content . 4
7.6 Determination of acid-insoluble ash content . 4
7.7 Determination of heavy metals content . 4
7.8 Determination of pesticide residues content . 4
7.9 Determination of marker compound . 4
8 Test report . 5
9 Packaging, storage and transportation . 5
10 Marking and labelling . 5
Annex A (informative) Thin-layer chromatogram identification . 6
Annex B (informative) Determination of moisture content . 7
Annex C (informative) Determination of marker compound by HPLC-UV .8
Annex D (informative) Referenced information of national and regional requirements .9
Bibliography .10
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ISO 4154:2022(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).
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expressions related to conformity assessment, as well as information about ISO's adherence to
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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 4154:2022(E)
Introduction
Sinomenium acutum stem is mainly produced in China and is also distributed in Japan. It has a long
history as one of the most commonly used traditional Chinese medicines to treat rheumatism and
[1]
arthralgia. Sinomenium acutum stem was first recorded in Bencao tujing (本草图经) and also called
[2]
qingteng or xunfengteng in Bencao gangmu (本草纲目).
The main chemical constituents of Sinomenium acutum stem include alkaloids, volatile oils, sterols
and lipids. Modern pharmacological studies have shown that the sinomenine in Sinomenium acutum
stem has definite benefits for analgesia, anti-inflammation, sedation, lowering blood-pressure, anti-
arrhythmia and immunosuppression. It is mainly used to treat rheumatoid arthritis, arrhythmia,
ankylosing spondylitis, pain and other diseases. At present, there are more than 10 kinds of Chinese
proprietary medicine, including zhengqing fengtongning pills, analgesic wine and qingfengteng tablets.
Although the curative effect of Sinomenium acutum stem is definite, side effects include allergic skin
rash, gastrointestinal reactions and granulocyte reduction. This is a reminder to the industry to be
cautious about the safety of Sinomenium acutum stem.
China, Japan, South Korea and Europe have established a standard for Sinomenium acutum stem in their
respective pharmacopoeias. But each pharmacopoeia's requirements are different. The Sinomenium
acutum stem standard has not been unified at the international level, and many countries have different
regulation levels.
As national implementation can differ, national standards bodies are invited to modify the values given
in 5.5, 5.6 and 5.7 in their national standards. An example of national values is given in Annex D.
The purpose of this document is to establish an International Standard for the quality and safety
control of Sinomenium acutum stem, ensure the safety and effectiveness of clinical drug use, regulate
the international market and reduce the occurrence of adverse events.
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INTERNATIONAL STANDARD ISO 4154:2022(E)
Traditional Chinese medicine — Sinomenium acutum stem
1 Scope
This document specifies the minimum quality and safety requirements of Sinomenium acutum stem
[the dried lianoid stem of Sinomenium acutum (Thunb.) Rehd. et Wils. and Sinomenium acutum (Thunb.)
Rehd. et Wils. var. cinereum Rehd. et Wils.].
This document applies to Sinomenium acutum stem that is sold and used as natural medicines in
international trade, including Chinese materia medica (whole medicinal materials) and decoction
pieces derived from these plants.
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/TS 21310, Traditional Chinese medicine — Microscopic examination of medicinal herbs
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
...
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