ISO 20759:2023

Traditional Chinese medicine - Artemisia argyi leaf

This document specifies the minimum requirements and test methods of Artemisia argyi leaf for medicinal use. It is suitable for identification and quality control of this herbal medicine.

Médecine traditionnelle chinoise — Artemisia argyi feuille

General Information

• Status: Published
• Publication Date: 05-Dec-2023
• 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: 06-Dec-2023
• Due Date: 12-Dec-2024
• Completion Date: 06-Dec-2023

Relations

• Revises: ISO 20759:2017 - Traditional Chinese medicine - Artemisia argyi leaf
• Effective Date: 17-Jun-2023

Overview

ISO 20759:2023 - "Traditional Chinese medicine - Artemisia argyi leaf" specifies minimum requirements and test methods for the dried leaf of Artemisia argyi (mugwort) intended for medicinal use. The standard is designed for reliable identification and quality control of Artemisia argyi leaf used in Traditional Chinese Medicine (TCM), moxibustion raw materials, pharmaceutical preparations and herbal healthcare products.

Key topics and technical requirements

• Scope & purpose: Minimum requirements and analytical methods for Artemisia argyi Lévl. et Vant. leaf (dried leaf) used as a medicinal herb.
• Macroscopic and microscopic identification:
  • Macroscopic: leaf shape, size (typically 5–9(16) cm long, 4–8(16) cm wide), greyish‑green upper surface and greyish‑white tomentose underside, specific aroma.
  • Microscopic: diagnostic features such as T‑shaped hairs, uniseriate soft hairs, glandular hairs, calcium oxalate cluster crystals, spiral and reticulate vessels.
• Chemical and analytical tests:
  • Thin-layer chromatographic (TLC) identification (Annex A): sample must show a purplish‑red spot for caryophyllene oxide at Rf = 0.55 ± 0.05 matching the reference.
  • Volatile oil and 1,8‑cineole determination (Annex B): volatile oil content and mass fraction of 1,8‑cineole (C10H18O) are to be measured.
  • Total flavonoids (Annex C): expressed as apigenin (C15H10O5), mass fraction to be determined.
  • Dilute ethanol‑soluble extract: mass fraction ≥ 12.0%.
  • Moisture: mass fraction ≤ 15.0%.
  • Total ash: mass fraction ≤ 12.0%.
  • Acid‑insoluble ash: mass fraction ≤ 3.0%.
• Sampling & batch size: maximum batch weight guidance (each batch ≤ 5 000 kg).
• Test methods & reporting: standardized methods for macroscopic/microscopic ID, TLC, volatile oil, flavonoids, extractives, moisture and ash determinations, plus packaging/storage/labeling guidance.
• Informative annexes: Annex D (comparative pharmacopoeial limits) and Annex E (habitat, cultivation, harvesting, processing factors).

Practical applications and users

• Who uses ISO 20759:2023:
  • TCM manufacturers and formulators sourcing Artemisia argyi leaf
  • Herbal raw material suppliers and quality control laboratories
  • Regulatory authorities and pharmacopoeia committees
  • Clinical product developers and moxibustion product makers
• Why it matters:
  • Ensures consistent identity and purity of mugwort leaf across supply chains
  • Supports compliance with pharmacopoeial and international trade requirements
  • Reduces variability in active constituents (volatile oils, flavonoids) that affect safety and efficacy
  • Provides standardized analytical methods for routine quality control and supplier verification

Related standards

• ISO 6571 - determination of volatile oil content (hydrodistillation)
• ISO 928, ISO 930, ISO 939 - methods for total ash, acid‑insoluble ash and moisture content
• ISO/TC 249 - Technical Committee on Traditional Chinese Medicine

Keywords: ISO 20759:2023, Artemisia argyi, mugwort leaf, Traditional Chinese Medicine, quality control, identification, volatile oil, 1,8‑cineole, total flavonoids, thin‑layer chromatography, TLC, moisture, total ash, dilute ethanol‑soluble extract.

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 20759
Second edition
2023-12
Traditional Chinese medicine —
Artemisia argyi leaf
Médecine traditionnelle Chinoise — Artemisia argyi feuille
Reference number
© ISO 2023
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]
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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 . .2
5 Requirements and recommendations . 3
5.1 General characteristics . 3
5.2 Macroscopic characteristics . 3
5.3 Microscopic characteristics . 3
5.4 Thin layer chromatogram . . 4
5.5 Volatile oil and 1,8-cineole (C H O) content . 5
10 18
5.6 Total flavonoids content . 5
5.7 Dilute ethanol-soluble extract . 5
5.8 Moisture content . 5
5.9 Total ash . 5
5.10 Acid-insoluble ash . 5
6 Sampling . 5
7 Test methods . 5
7.1 Macroscopic identification . 5
7.2 Microscopic identification . 6
7.3 Thin-layer chromatographic identification . 6
7.4 Determinations of volatile oil content and 1,8-cineole(C H O) content . 6
10 18
7.5 Determination of total flavonoids content . 6
7.6 Determination of dilute ethanol-soluble extract . 6
7.7 Determination of moisture content . 6
7.8 Determination of total ash . 6
7.9 Determination of acid-insoluble ash . 6
8 Test report . 6
9 Packaging, storage and transportation . 7
10 Marking and labelling . 7
Annex A (normative) Thin layer chromatographic identification of Artemisia argyi leaf .8
Annex B (normative) Determination of volatile oil and 1,8-cineole contents in Artemisia
argyi leaf .10
Annex C (normative) Determination of total flavonoids content in Artemisia argyi leaf .12
Annex D (informative) Limit values of 1,8-cineole, dilute ethanol-soluble extract,
moisture, total ash and acid-insoluble ash of mugwort leaf (Artemisia argyi leaf) in
pharmacopoeias of different countries and regions .13
Annex E (informative) Habitat, cultivation, harvesting and processing of Artemisia argyi
Lévl. et Vant .14
Bibliography .15
iii
Foreword
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bodies (ISO member bodies). The work of preparing International Standards is normally carried out
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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 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
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Any trade name used in this document is information given for the convenience of users and does not
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For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
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.
This second edition cancels and replaces the first edition (ISO 20759:2017), of which it constitutes a
minor revision. The changes are as follows:
— in 3.6, cross-reference to 7.7 corrected to 7.6;
— Clause 10 g) removed to comply with updated drafting rules;
— in Annex D, edition dates of the Chinese Pharmacopoeia and the Taiwan Herbal Pharmacopoeia
updated; all data from the Japanese Pharmacopoeia removed due to difference of the original plant
of mugwort leaf;
— minor editorial changes.
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
Mugwort leaf is a traditional herbal medicine. It is mainly used for the treatment of irregular
menstruation, infertility, hematemesis, epistaxis, metrorrhagia and pruritus in China and some
other countries. It is also the raw material for the famous moxibustion therapy, many pharmaceutical
preparations and healthcare products. Mugwort leaf originates from the three species of plants
Artemisia argyi Lévl. et Vant., Artemisia princeps Pampanini and Artemisia montana Pampanini. The
three original species mainly grow in China and Korea, and the second and third species also grow
in Japan. Among them, the dried leaf of Artemisia argyi Lévl. et Vant. has been used most extensively
worldwide. This document was developed mainly to control the quality of Artemisia argyi leaf for direct
medicinal and pharmaceutical purposes.
For reference, the limit values of the relevant target substance and moisture, total ash and acid-
insoluble ash have been provided in Annex D. In addition, factors affecting the quality of Artemisia
argyi leaf include pH and organic matters of soil, light, harvest time, as well as cultivation techniques.
These factors cannot be controlled by sample analysis. Therefore, relevant information is described in
Annex E as a reference.
v
INTERNATIONAL STANDARD ISO 20759:2023(E)
Traditional Chinese medicine — Artemisia argyi leaf
1 Scope
This document specifies the minimum requirements and test methods of Artemisia argyi leaf for
medicinal use. It is suitable for identification and quality control of this herbal medicine.
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 928, Spices and condiments — Determination of total ash
ISO 930, Spices and condiments — Determination of acid-insoluble ash
ISO 939, Spices and condiments — Determination of moisture content
ISO 6571, Spices, condiments and herbs — Determination of volatile oil content (hydrodistillation method)
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
Artemisia argyi leaf
dried leaf of the plant Artemisia argyi Lévl. et Vant., which belongs to the family Asteraceae
3.2
reference medicine
authentic medicine from the dried leaf of Artemisia argyi Lévl. et Vant., used for reference in thin layer
chromatogram analyses of the sample
3.3
volatile oil content
substances in the sample entrained by steam under the conditions specified in Annex B
Note 1 to entry: It is expressed in ml per 100 g of dry duct.
[SOURCE: ISO 6571:2008, 3.1, modified — Definition revised.]
3.4
1,8-cineole content
mass fraction of 1,8-cineole (C H O) in the sample determined in accordance with the method of
10 18
Annex B
3.5
total flavonoids content
mass fraction of the total flavonoids in the sample determined in accordance with the method in
Annex C
3.6
dilute ethanol-soluble extract
extract obtained from the sample determined in accordance with the method specified in 7.6
4 Description
In this document, Artemisia argyi leaf is the dried leaf from the plant Artemisia argyi Lévl. et Vant. (see
Figure 1 A) and consists of leaf blade and petiole (see Figure 1 B).
Key
A plant of Artemisia argyi Lévl. et Vant. 4 dentate segment/wide sawtooth
B leaves of the middle stem of Artemisia argyi Lévl. et Vant. 5 petiole
1 leaf blade 6 leaf blade width
2 stem 7 leaf blade length
3 segment
Figure 1 — Plant of Artemisia argyi Lévl. et Vant. and structure of the leaf
5 Requirements and recommendations
5.1 General characteristics
The following requirements should be met before separating the bulk sample into test samples:
a) Artemisia argyi leaf shall be clean and free from foreign matter.
b) The presence of mouldy leaves, external contaminants and living insects which are visible to the
naked eye shall not be permitted.
5.2 Macroscopic characteristics
The leaves are mostly crumpled or broken, with short petioles and usually without pseudostipule at
the base. The leaf blade is broad ovate, rhombic-ovate or ovate-elliptical, 5 cm to 9(16) cm long, 4 cm
to 8(16) cm wide and pinnatipartite to pinnatifid; segments in two or three pairs, elliptical-lanceolate,
or elliptical-oblanceolate, frequently 1 cm to 1,5(3) cm wide, with margins irregularly dentate or
lobed or wide serrate, dentate piece or wide sawtooth, mostly asymmetrically ovate-lanceolate, ovate-
triangular or entire. Smaller leaves are fewer, pinnatipartite, tri-cleft, sometimes entire and elliptical
to lanceolate. The upper surface is greyish-green or dark yellowish-green, possessing somewhat sparse
pubescences, denser glandular dots and small pits; the lower surface is covered densely with greyish-
white tomenta. The petiole is usually 2 mm to 8 mm long and up to 1,3 cm in the cultivated plants.
It has a specific, delicate aroma and a slightly bitter and astringent taste.
5.3 Microscopic characteristics
The powder is greenish-brown. T-shaped hairs (A) are numerous, with a short uniseriate stalk
consisting of two to six small cells, and perpendicularly capped by a relatively straight or undulating
terminal cell (7 μm to 18 μm in diameter and up to 980 μm long) tapering at the ends. Soft hairs (B) are
uniseriate, consisting of three to five cells, with a very long and twisted apical cell, which are frequently
broken. Glandular hairs (C), without stalk, consist of four or six oppositely-overlapped cells in lateral
view (Ca) and in pairs and paramecium-like in apical view (Cb). Cluster crystals of calcium oxalate (D)
are frequently 3 μm to 12 μm in diameter, mostly occurring in mesophyll cells. Fragments of epidermis
in surface view (E) are with anomocytic stomas. Fragments of spiral vessels (F) can be frequently seen;
vessels with bordered pit (G) and reticulate vessels (H) are sometimes visible (see Figure 2).
Key
A T-shaped hair
B uniseriate soft hair
C glandular hair
Ca glandular hair in lateral view
Cb glandular hair in apical view
D cluster crystal of calcium oxalate
E fragment of epidermis in surface view
F spiral vessel
G vessel with bordered pit
H reticulate vessel
Figure 2 — Illustration of powdered Artemisia argyi leaf
5.4 Th
...