ISO 20759:2017
(Main)Traditional Chinese medicine — Artemisia argyi leaf
Traditional Chinese medicine — Artemisia argyi leaf
ISO 20759:2017 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.
La médecine traditionnelle Chinoise — Artemisia argyi feuille
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Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 20759
First edition
2017-12
Traditional Chinese medicine —
Artemisia argyi leaf
La médecine traditionnelle Chinoise — Artemisia argyi feuille
Reference number
©
ISO 2017
© ISO 2017, Published in Switzerland
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ii © ISO 2017 – All rights reserved
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Description . 2
5 Requirements . 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 . 4
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 . 5
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 the different countries and regions .13
Annex E (informative) Habitat,cultivation, harvesting and processing of
Artemisia argyi Lévl. et Vant. .14
Bibliography .15
Foreword
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This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
iv © ISO 2017 – All rights reserved
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 famous moxibustion therapy, many pharmaceutical preparations
and health care products. Mugwort leaf originates from the three species of plants Artemisia argyi Lévl.
et Vant., Artemisia princeps Pampanini or Artemisia montana Pampanini in different countries. 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 in
the world. This document is established mainly to control the quality of Artemisia argyi leaf for direct
medicinal and pharmaceutical purpose.
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 also
include pH and organic matters of soil, light, harvest time, as well as cultivation techniques and so on.
These factors cannot be controlled by sample analysis. Therefore, relevant information is described in
Annex E as a reference.
INTERNATIONAL STANDARD ISO 20759:2017(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 — Entrainment method
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 terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at http://www.iso.org/obp
— IEC Electropedia: available at http://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 reference medicine from the dried leaf of Artemisia argyi Lévl. et Vant., used for reference in
TLC analyses of the sample
3.3
volatile oil content
all the 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 — “in the sample” has been inserted and the term “International
Standard” has been replaced with “Annex B”.]
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 7.7
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).
A
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 Van
...
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