ISO 8071:2024

Traditional Chinese medicine - Ligusticum chuanxiong rhizome

This document specifies the quality requirements of Ligusticum chuanxiong rhizome (rhizome of Ligusticum chuanxiong Hort.). This document applies to Ligusticum chuanxiong rhizome that is sold and used as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this rhizome.

Médecine traditionnelle chinoise — Rhizome de livèche du Sichuan (Ligusticum chuanxiong)

General Information

• Status: Published
• Publication Date: 14-Mar-2024
• ICS: 11.120.10 - Medicaments
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249 - Traditional Chinese medicine
• Current Stage: 6060 - International Standard published
• Start Date: 15-Mar-2024
• Due Date: 15-Sep-2024
• Completion Date: 15-Mar-2024

Overview

ISO 8071:2024 - Traditional Chinese medicine - Ligusticum chuanxiong rhizome is the first international standard that defines quality requirements for the dried rhizome of Ligusticum chuanxiong Hort. (chuanxiong rhizome). Published by ISO (Technical Committee ISO/TC 249) in March 2024, the standard applies to whole materia medica and decoction pieces sold or used as natural medicine in international trade. It establishes descriptive, safety and analytical expectations to support consistent quality, testing and labelling across markets.

Key Topics and Technical Requirements

ISO 8071:2024 covers both macroscopic and microscopic description and specific quality controls, including:

• Morphological features: shape, surface texture, colour, typical section appearance and sensory attributes (e.g., intense characteristic aroma; slightly numbing, slightly sweet aftertaste). The rhizome is typically 2–7 cm in diameter.
• Microscopic features and powder characteristics: cork, cortex, phloem, cambium structure; oil cavities; abundant starch grains (simple grains 3 µm–19 µm, up to 22 µm long), and typical vessel/fibre descriptions.
• Chemical and safety parameters: identification and quantification of a marker compound (Annex A describes determination of ferulic acid), extractives, essential oil content, moisture, total and acid‑insoluble ash.
• Contaminant limits and tests: foreign matter, heavy metals, pesticide residues, sulfur dioxide, aflatoxins.
• Sampling, test methods and reporting: standardized procedures for sampling, macroscopic/microscopic identification, chemical assays and how to document results.
• Product handling and market information: marking and labelling requirements, packaging, storage and transportation, plus guidance on traditional grade information (Annex C).

Note: national bodies may adapt numeric limits in clauses 5.4–5.10 to reflect regional regulations (see Annex B).

Practical Applications - Who Uses This Standard

ISO 8071:2024 is useful for:

• Manufacturers and processors of traditional Chinese medicinal materials and decoction pieces - to set internal quality specs and production controls.
• Quality control and analytical laboratories - to adopt standardized sampling and test methods (chemical, microscopic and contaminant testing).
• Exporters / importers and traders - to ensure consignments meet internationally recognized criteria for trade.
• Regulators and certification bodies - to harmonize inspection, registration and market surveillance.
• Traditional Chinese medicine practitioners and formulators - to verify raw material authenticity and safety for clinical use.

Related Standards

ISO 8071:2024 references and aligns with other TCM standards, including:

• ISO 18664 (heavy metals)
• ISO/TS 21310 (microscopic examination)
• ISO 21371 (labelling)
• ISO 22217 (storage)
• ISO 22258 (pesticide residues)
• ISO 22283 (aflatoxins)
• ISO 22590 (sulfur dioxide)
• ISO 23723 (general requirements for herbal raw material)

Adoption of ISO 8071:2024 helps harmonize quality control for Ligusticum chuanxiong rhizome in global TCM supply chains, improving safety, traceability and market access.

Standards Content (Sample)

International
Standard
ISO 8071
First edition
Traditional Chinese medicine —
2024-03
Ligusticum chuanxiong rhizome
Médecine traditionnelle chinoise — Rhizome de livèche du
Sichuan (Ligusticum chuanxiong)
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: [phone]
Email: [e-mail]
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 . 1
5 Requirements and recommendations . 2
5.1 General .2
5.2 Morphological features .2
5.3 Microscopic features .3
5.4 Marker compound .4
5.5 Extractives .4
5.6 Total ash .4
5.7 Acid-insoluble ash .4
5.8 Moisture .4
5.9 Essential oil.4
5.10 Foreign matter .4
5.11 Heavy metals .4
5.12 Pesticide residues .4
5.13 Sulfur dioxide . .4
5.14 Aflatoxin .4
6 Sampling . 4
7 Test methods . 4
7.1 Macroscopic identification .4
7.2 Microscopic identification .5
7.3 Determination of marker compound .5
7.4 Determination of extractives .5
7.5 Determination of total ash .5
7.6 Determination of acid-insoluble ash .5
7.7 Determination of moisture .5
7.8 Determination of essential oil . .5
7.9 Determination of foreign matter .5
7.10 Determination of heavy metals .5
7.11 Determination of pesticide residues .5
7.12 Determination of sulfur dioxide .5
7.13 Determination of aflatoxin .5
8 Test report . 5
9 Marking and labelling . 6
10 Packaging, storage and transportation . 6
Annex A (informative) Determination of ferulic acid . 7
Annex B (informative) Reference of national and regional requirements .11
Annex C (informative) An example of traditional grade information for Ligusticum chuanxiong
rhizome .13
Bibliography . 14

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
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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
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)
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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
Ligusticum chuanxiong rhizome is one of the most commonly used Chinese materia medica in traditional
Chinese medicine. The use of Ligusticum chuanxiong rhizome in medicine was first recorded in Shennong
Bencao Jing (also called Shennong Emperor's Classic of Materia Medica) more than 2 000 years ago. And it
has been artificially planted for traditional Chinese medicine (rhizome) or food (leaf) use as Tao Hongjing
described 1 500 years ago.
Ligusticum chuanxiong rhizome has the effect of activating blood and dissolving stasis, dispelling wind
and relieving pain. Clinically, it is often used with Chinese materia medica for the purpose of awakening,
resuscitation and blood nourishing. It is the main active ingredient in many well-known prescriptions,
such as Siwu decoction and Suxiao Jiuxin pills, and is present in about 30 % of traditional Chinese medicine
[3]
prescriptions. For example, among 1 607 formulae in the Pharmacopoeia of the People's Republic of China ,
246 (15,3 %) contain Ligusticum chuanxiong rhizome.
Ligusticum chuanxiong rhizome and its products are widely used in 13 countries and regions, including Japan,
Malaysia, Singapore, the Republic of Korea and Viet Nam. According to the 'Circulation Market Analysis
Report for Traditional Chinese Medicinal Materials' by the Chinese ministry of commerce, the export volume
of Ligusticum chuanxiong rhizome was 9 160,4 tons in 2014. Therefore, there is clearly a large demand for
Ligusticum chuanxiong rhizome in the international market.
Currently, there is no globally unified standard on the quality, specification and grade of Ligusticum
chuanxiong rhizome. Therefore, creating an International Standard for Ligusticum chuanxiong rhizome is of
great significance.
As national implementation can differ, national standards bodies are invited to modify the values given in
5.4 to 5.10 according to their national requirements. Examples of national and regional values are given in
Annex B. An example of traditional grade information for Ligusticum chuanxiong rhizome is given in Annex C.

v
International Standard ISO 8071:2024(en)
Traditional Chinese medicine — Ligusticum chuanxiong rhizome
1 Scope
This document specifies the quality requirements of Ligusticum chuanxiong rhizome (rhizome of Ligusticum
chuanxiong Hort.).
This document applies to Ligusticum chuanxiong rhizome that is sold and used as natural medicine in
international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces
derived from this rhizome.
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 22283, Traditional Chinese medicine — Determination of aflatoxins in natural products by LC-FLD
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 standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
Ligusticum chuanxiong rhizome
dried rhizome of Ligusticum chuanxiong Hort. (Apiaceae), after primary processing
4 Descriptions
Ligusticum chuanxiong rhizome is the dried r
...