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

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Status
Published
Publication Date
11-May-2022
Current Stage
4060 - Close of voting
Start Date
29-Oct-2021
Completion Date
28-Oct-2021
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ISO 4154:2022 - Traditional Chinese medicine — Sinomenium acutum stem Released:5/12/2022
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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 2022 – All rights reserved
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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

iii
© ISO 2022 – All rights reserved
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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

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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).

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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.
© ISO 2022 – All rights reserved
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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.
© ISO 2022 – All rights reserved
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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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