ISO 24902:2026
(Main)Traditional Chinese medicine — Zanthoxylum nitidum root
General Information
- Abstract
This document specifies the minimum requirements and test methods for Zanthoxylum nitidum root. This document applies to Zanthoxylum nitidum root sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
- Status
- Published
- Publication Date
- 10-Aug-2026
- Technical Committee
- ISO/TC 249 - Traditional Chinese medicine
- Current Stage
- 6060 - International Standard published
- Start Date
- 11-Aug-2026
- Due Date
- 01-Mar-2027
- Completion Date
- 11-Aug-2026
Overview
ISO 24902:2026 – Traditional Chinese medicine - Zanthoxylum nitidum root establishes the minimum quality requirements and test methods for Zanthoxylum nitidum root. This standard applies to the root as sold and used in Chinese materia medica, encompassing both whole medicinal materials and decoction pieces. Zanthoxylum nitidum root, commonly known as Liang-Mian-Zhen, is widely used in traditional Chinese medicine across numerous countries for its therapeutic properties. Ensuring consistent quality and safety through standardized guidelines is vital for both consumer safety and the promotion of international trade.
Key Topics
- General Quality Requirements: Zanthoxylum nitidum root must be free of foreign matter, living insects, mold, and visible contaminants.
- Morphological and Microscopic Identification: The root is characterized by its thick, pale brownish-yellow slices or cylindrical sections with unique internal structures distinguishable under microscopic examination.
- Chemical Testing and Identification:
- Thin-Layer Chromatography (TLC): Used for accurate identification and adulterant detection.
- Determination of Marker Compounds: Analysis of specific alkaloids, particularly nitidine chloride.
- Moisture and Total Ash Content: Limitations ensure product integrity.
- Ethanol-Soluble Extractives: Assurance of key component concentration.
- Safety Controls:
- Heavy Metal and Pesticide Residue Testing: Limits set for contaminants such as lead, mercury, arsenic, and common pesticide residues.
- Sampling and Test Methods: Detailed protocols based on related ISO standards ensure reliability and reproducibility.
- Packaging, Storage, and Labelling: Requirements to minimize contamination, degradation, and misidentification.
Applications
Zanthoxylum nitidum root is used widely in traditional Chinese medicine for treating a variety of conditions such as stomachache, toothache, rheumatic complaints, injuries, and snake bites. Beyond its medicinal uses, standardization of Zanthoxylum nitidum root benefits:
- Herbal Medicine Manufacturers: Supports quality control in production and ensures compliance with international best practices.
- Healthcare Practitioners: Helps in sourcing authentic and standardized herbal materials for clinical application.
- Regulatory Authorities: Provides a scientific basis for market surveillance, import/export controls, and consumer safety assurance.
- Research Institutions: Facilitates the study of pharmacological effects, toxicity, and safe use of traditional Chinese medicine materials.
- International Trade: Supports harmonized quality criteria for raw materials, facilitating smoother trade and mutual recognition across countries.
Related Standards
ISO 24902:2026 references and complements several key standards in the field of medicinal plant quality assurance:
- ISO 18664 – Determination of heavy metals in herbal medicines
- ISO/TS 21310 – Microscopic examination of medicinal herbs
- ISO 21371 – Labelling requirements for oral or topical use herbal products
- ISO 22217:2020 – Storage requirements for raw materials and decoction pieces
- ISO 22258 – Determination of pesticide residues in natural products
- ISO 23723:2021 – General requirements for herbal raw material and materia medica
By aligning with these standards, ISO 24902:2026 ensures a comprehensive framework for the quality and safety management of Zanthoxylum nitidum root in traditional Chinese medicine.
Keywords: ISO 24902:2026, Zanthoxylum nitidum root, Traditional Chinese medicine, quality requirements, test methods, herbal medicine, materia medica, safety, identification, herbal quality control, pharmacopoeia, international trade in medicinal plants.
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Frequently Asked Questions
ISO 24902:2026 is a standard published by the International Organization for Standardization (ISO). Its full title is "Traditional Chinese medicine — Zanthoxylum nitidum root". This standard covers: This document specifies the minimum requirements and test methods for Zanthoxylum nitidum root. This document applies to Zanthoxylum nitidum root sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
This document specifies the minimum requirements and test methods for Zanthoxylum nitidum root. This document applies to Zanthoxylum nitidum root sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
ISO 24902:2026 is classified under the following ICS (International Classification for Standards) categories: 11.120.10 - Medicaments. The ICS classification helps identify the subject area and facilitates finding related standards.
ISO 24902:2026 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
International
Standard
ISO 24902
First edition
Traditional Chinese medicine —
2026-08
Zanthoxylum nitidum root
Médecine traditionnelle chinoise — Racine de Zanthoxylum
nitidum
Reference number
© ISO 2026
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.
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Email: copyright@iso.org
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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 Description . . 1
5 Requirements and recommendations . 2
5.1 General characteristics .2
5.2 Morphological features of root.2
5.3 Microscopic identification .3
5.4 Thin-layer chromatogram (TLC) identification .3
5.5 Moisture .4
5.6 Total ash .4
5.7 Ethanol-soluble extractives .4
5.8 Heavy metals .4
5.9 Pesticide residues .4
5.10 Marker compounds .4
6 Sampling . 4
7 Test methods . 4
7.1 Macroscopic identification .4
7.2 Microscopic identification .4
7.3 Thin-layer chromatogram (TLC) identification .4
7.4 Determination of moisture .4
7.5 Determination of total ash .4
7.6 Toddalolactone identification .4
7.7 Determination of ethanol-soluble extractives .5
7.8 Determination of heavy metals .5
7.9 Determination of pesticide residues .5
7.10 Determination of marker compounds .5
8 Test report . 5
9 Packaging, storage and transportation . 5
10 Marking and labelling . 5
Annex A (informative) Thin-layer chromatogram (TLC) identification . 6
Annex B (informative) Determination of marker compounds by HPLC-UV . 8
Annex C (informative) Reference information of national and regional requirements .10
Bibliography .12
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
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)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
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This document was prepared by Technical Committee ISO/TC 249, Traditional medicine, Subcommittee SC 1,
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
Zanthoxylum nitidum root (the Chinese Pinyin name: Liang-Mian-Zhen) is the dried root of Zanthoxylum
nitidum (Roxb.) DC., which is known in China as Liang-Mian-Zhen. It is mainly distributed in southern China
and Viet Nam. Zanthoxylum nitidum root and its products are sold in China, Japan, Thailand, Myanmar,
Singapore, Malaysia, the United States, Uganda, and many other countries. It is widely used in traditional
Chinese medicine for treating stomachache, toothache, rheumatic arthralgia, traumatic injury, and venomous
snake bites. Additional medical applications include the treatment of inflammations, various types of cancer,
bacterial and viral infections, gastric and oral ulcers, and liver damage.
Zanthoxylum nitidum root contains a variety of effective chemical components, including alkaloids,
coumarins, lignans, sterols, flavonoids, and volatile oils, among which alkaloids have the highest content,
accounting for about 0,7 %. Modern pharmacological studies have shown that Zanthoxylum nitidum root has
anti-inflammatory, analgesic, antioxidant and anti-tumour effects. The anti-inflammatory and analgesic
effects of Zanthoxylum nitidum root are widely used in the treatment of bruises, stomach pain, toothache,
and rheumatism.
The alkaloids are the main active components of Zanthoxylum nitidum root. Nitidine chloride is one of the
most frequently used alkaloids in Zanthoxylum nitidum root to study its various pharmacological effects.
At the same time, studies have also shown that the alkaloids in Zanthoxylum nitidum root have a certain
degree of toxicity and can cause toxic effects such as hepatocyte toxicity, renal cytotoxicity, developmental
toxicity and cardiotoxicity.
On the market, the quality of Zanthoxylum nitidum root is uneven. There are forgeries and adulterations. The
common forgeries and confused products of Zanthoxylum nitidum root are the stem of Zanthoxylum nitidum
(Roxb.) DC. and roots from the plants of Toddalia asiatica (L.) Lam., Zanthoxylum armatum DC., Zanthoxylum
dimorphophyllum Hemsl. var. spinifolium Rehd.et Wils.
The quality evaluation of Zanthoxylum nitidum root in Chinese Pharmacopoeia has inspection items that are
different from Zanthoxylum nitidum (Roxb.) DC. prodr. var. tomentosum Huang.
The development of standards for the quality and safety control of Zanthoxylum nitidum root can provide a
reference for better development and use of Zanthoxylum nitidum root. Moreover, Zanthoxylum nitidum root
is ranked no. 94 in the priority list of single herbal medicines for developing standards in ISO/TR 23975.
[1]
Thus, it is essential to develop an International Standard for Zanthoxylum nitidum root to ensure the
consistency in the quality of Zanthoxylum nitidum root, which can contribute to the safe use of this herb and
also promote the international trade.
In this document, the identification of commonly adulterated species of Zanthoxylum nitidum root is also
introduced.
As national implementation can differ in different countries, national standards bodies are invited to modify
the values given in 5.8 and 5.10 in their national standards. Examples of national and regional values are
given in Annex C.
v
International Standard ISO 24902:2026(en)
Traditional Chinese medicine — Zanthoxylum nitidum root
1 Scope
This document specifies the minimum requirements and test methods for Zanthoxylum nitidum root.
This document applies to Zanthoxylum nitidum root sold and used as Chinese materia medica (whole
medicinal materials) and decoction pieces derived from this plant.
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 — Dete
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