ISO 20759:2023

INTERNATIONAL ISO
STANDARD 20759
Second edition
2023-12
Traditional Chinese medicine —
Artemisia argyi leaf
Médecine traditionnelle Chinoise — Artemisia argyi feuille
Reference number
© ISO 2023
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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
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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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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
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Annex B
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