ISO 4154:2022

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

• Status: Published
• Publication Date: 11-May-2022
• ICS: 11.120.10 - Medicaments
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249/WG 1 - Quality and safety of raw materials and traditional processing
• Current Stage: 6060 - International Standard published
• Start Date: 12-May-2022
• Due Date: 02-Mar-2023
• Completion Date: 12-May-2022

Overview

ISO 4154:2022 - Traditional Chinese medicine - Sinomenium acutum stem defines international minimum quality and safety requirements for the dried lianoid stem of Sinomenium acutum (including var. cinereum). The standard applies to raw Chinese materia medica and decoction pieces sold and used as natural medicines in international trade. Its purpose is to harmonize quality control, protect patient safety and support regulatory and commercial consistency for this widely used TCM ingredient.

Key topics and technical requirements

• Identity and description
  • Macroscopic and microscopic descriptions (stem morphology, bark, pith, wood rays, epidermis, xylem/phloem features).
  • Powder characteristics (color, cell types, calcium oxalate crystals).
• Chemical and analytical identification
  • Thin-layer chromatogram (TLC): sample must show spots matching reference solutions.
  • Marker compound: sinomenine (C19H23NO4) content not less than 0.50% of dried material when used as the marker.
• Quality limits
  • Moisture: mass fraction ≤ 13.0%
  • Total ash: mass fraction ≤ 6.0%
  • Acid‑insoluble ash: mass fraction ≤ 0.5%
• Safety testing
  • Determination of heavy metals (e.g., arsenic, mercury, lead, cadmium).
  • Determination of pesticide residues.
• Sampling and test methods
  • Sampling per ISO 23723:2021 (Clause 8).
  • Test methods reference ISO/TS 21310 (microscopy), ISO 18664 (heavy metals), ISO 22258 (pesticide residues), and other ISO test procedures or informative annexes (moisture, TLC, HPLC-UV for marker compound).
• Packaging, storage, labelling
  • Requirements for storage, transport and labelling are included to ensure product integrity in trade.

Applications and practical value

• Manufacturers and processors: set incoming raw material acceptance criteria and validate processing/decoction piece quality.
• Quality control and analytical laboratories: implement standardized test methods (TLC, moisture, ash, heavy metals, pesticide screens, HPLC for sinomenine).
• Regulators and customs/importers: assess compliance of Sinomenium acutum stem in international trade and align national pharmacopoeial requirements.
• Product formulators and TCM companies: ensure consistent sinomenine content and safety profile in proprietary medicines (e.g., anti‑rheumatic preparations).
• Supply chain managers: apply harmonized sampling and storage rules to reduce recalls and adverse events.

Related standards

• ISO 23723:2021 - General requirements for herbal raw material and materia medica (sampling)
• ISO/TS 21310 - Microscopic examination of medicinal herbs
• ISO 18664 - Determination of heavy metals in TCM herbal medicines
• ISO 22258 - Determination of pesticide residues by gas chromatography
• ISO 21371 - Labelling requirements for TCM products
• ISO 22217 - Storage requirements for raw materials and decoction pieces

Keywords: ISO 4154:2022, Sinomenium acutum stem, traditional Chinese medicine, sinomenine, quality and safety requirements, TLC identification, heavy metals, pesticide residues, moisture limit, total ash.

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 2022
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
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Phone: [phone]
Email: [e-mail]
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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 . 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
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
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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
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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
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.
v
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
...