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

General Information

Status
Published
Publication Date
11-Dec-2017
Current Stage
6060 - International Standard published
Start Date
01-Nov-2017
Completion Date
12-Dec-2017
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ISO 20759:2017 - Traditional Chinese medicine -- Artemisia argyi leaf
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INTERNATIONAL ISO
STANDARD 20759
First edition
2017-12
Traditional Chinese medicine —
Artemisia argyi leaf
La médecine traditionnelle Chinoise — Artemisia argyi feuille
Reference number
ISO 20759:2017(E)
ISO 2017
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ISO 20759:2017(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form

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ii © ISO 2017 – All rights reserved
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ISO 20759:2017(E)
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

© ISO 2017 – All rights reserved iii
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ISO 20759:2017(E)
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 ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

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 documents 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).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation on 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 the following

URL: www.iso.org/iso/foreword.html.

This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.

iv © ISO 2017 – All rights reserved
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ISO 20759:2017(E)
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.
© ISO 2017 – All rights reserved v
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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
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ISO 20759:2017(E)
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).
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
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ISO 20759:2017(E)
5 Requirements
5.1 General characteristics

The following requirements should be met before separating the bulk sample into test samples.

a) Artermisia argyi leaf shall be clean and free from foreign matter.

b) The presence of moldy 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 margin 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, and 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; 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 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).

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ISO 20759:2017(E)
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 Thin layer chromatogram

The chromatogram of the sample solution shall exhibit a purplish-red spot corresponding to

caryophyllene oxide at the same Rf value (0,55 ± 0,05) as caryophyllene oxide from the reference

solution, and exhibit main spots with the same colours corresponding to those from the reference

medicine solution at the same Rf values.
5.5 Volatile oil and 1,8-cineole (C H O) content
10 18
The volatile oil content and the mass fraction of 1,8-cineole shou
...

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