Traditional Chinese medicine -- Angelica sinensis root

This document specifies minimum requirements and test methods for Angelica sinensis root that is derived from Angelica sinensis (Oliv.) Diels. It is applicable to Angelica sinensis root that is sold and used as a natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.

Médecine traditionnelle chinoise -- Racine d'Angélique chinoise

General Information

Status
Published
Publication Date
04-Dec-2019
Current Stage
6060 - International Standard published
Start Date
02-Nov-2019
Completion Date
05-Dec-2019
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ISO 22584:2019 - Traditional Chinese medicine -- Angelica sinensis root
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INTERNATIONAL ISO
STANDARD 22584
First edition
2019-12
Traditional Chinese medicine —
Angelica sinensis root
Médecine traditionnelle chinoise — Racine d'Angélique chinoise
Reference number
ISO 22584:2019(E)
ISO 2019
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ISO 22584:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

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Published in Switzerland
ii © ISO 2019 – All rights reserved
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ISO 22584:2019(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Description ................................................................................................................................................................................................................. 2

5 Requirements .......................................................................................................................................................................................................... 2

5.1 General characteristics ..................................................................................................................................................................... 2

5.2 Morphological features of Angelica sinensis root....................................................................................................... 2

5.3 Identification of Angelica sinensis root ............................................................................................................................... 3

5.4 Moisture ........................................................................................................................................................................................................ 3

5.5 Total ash ........................................................................................................................................................................................................ 3

5.6 Acid-insoluble ash ................................................................................................................................................................................ 3

5.7 Extractives ......... .......................................................................................................................................................................................... 3

5.8 Content of maker compound ...................................................................................................................................................... 3

5.9 Heavy metal ............................................................................................................................................................................................... 3

5.10 Pesticide residues ................................................................................................................................................................................. 4

6 Sampling ........................................................................................................................................................................................................................ 4

7 Test methods ............................................................................................................................................................................................................. 4

7.1 Macroscopic identification ........................................................................................................................................................... 4

7.2 TLC identification ................................................................................................................................................................................. 4

7.3 Determination of moisture content ...................................................................................................................................... 4

7.4 Determination of total ash ............................................................................................................................................................ 4

7.5 Determination of acid-insoluble ash .................................................................................................................................... 4

7.6 Determination of extractives ...................................................................................................................................................... 4

7.7 Determination of ferulic acid ...................................................................................................................................................... 4

7.8 Determination of heavy metal ................................................................................................................................................... 4

7.9 Determination of pesticide residues .................................................................................................................................... 4

8 Test report ................................................................................................................................................................................................................... 4

9 Packaging, storage and transportation ......................................................................................................................................... 5

10 Marking and labelling ..................................................................................................................................................................................... 5

Annex A (informative) TLC identification........................................................................................................................................................ 6

Annex B (informative) Determination of extractives .......................................................................................................................... 9

Annex C (informative) Determination of ferulic acid .......................................................................................................................10

Annex D (informative) Reference values of Angelica sinensis root in different national and

regional standards ...........................................................................................................................................................................................12

Bibliography .............................................................................................................................................................................................................................13

© ISO 2019 – All rights reserved iii
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ISO 22584:2019(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 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.

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 © ISO 2019 – All rights reserved
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ISO 22584:2019(E)
Introduction

Angelica root is a traditional herbal remedy, derived from the dried root of Angelica sinensis (Oliv.) Diels,

Angelica acutiloba (Sieb. et Zucc.) Kitagawa and Angelica gigas Nakai, of the Umbelliferae family, as

recorded by the Chinese Pharmacopoeia, the Japanese Pharmacopoeia and the Korean Pharmacopoeia,

respectively, and has a long medicinal history. Angelica sinensis is still one of the herbs most commonly

used by traditional Chinese medicine practitioners in Asia, North America and Europe. It is commonly

known as female ginseng, and widely used to invigorate blood circulation and replenish blood in treating

women's reproductive problems, such as dysmenorrhea, amenorrhoea and menopause. It has also been

used in over 20 countries for its significant effectiveness in the pharmaceutical and cosmetic fields.

The quality of Angelica sinensis root is crucial for efficacy and safety for consumers. Until now, there

have been no unique requirements for Angelica sinensis root, although Angelica sinensis root has also

been recorded by the American Herbal Pharmacopoeia, the European Pharmacopoeia, the British

Pharmacopoeia and the Hong Kong Chinese Materia Medica Standards. It is therefore important to

standardize the quality of Angelica sinensis root globally in order to benefit farmers, enterprises and

companies involved in the planting, management and trade of Angelica sinensis root.

As national implementation may differ, national standards bodies are invited to modify the values given

in 5.4, 5.5, 5.6, 5.7, 5.8, 5.9 and 5.10 in their national standards. Examples of national and regional values

are given in Annex D.
© ISO 2019 – All rights reserved v
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INTERNATIONAL STANDARD ISO 22584:2019(E)
Traditional Chinese medicine — Angelica sinensis root
1 Scope

This document specifies minimum requirements and test methods for Angelica sinensis root that is

derived from Angelica sinensis (Oliv.) Diels.

It is applicable to Angelica sinensis root that is sold and used as a natural medicine in international

trade, including 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 1575, Tea — Determination of total ash
ISO 1577, Tea — Determination of acid-insoluble ash

ISO 18664, Traditional Chinese Medicine — Determination of heavy metals in herbal medicines used in

Traditional Chinese Medicine
ISO 20409, Traditional Chinese medicine — Panax notoginseng root and rhizome

ISO 21371, Traditional Chinese medicine — Labelling requirements of products intended for oral or topical use

CAC/MRL01 Maximum Residue Limits for Pesticides in Foods
CODEX STAN 229, Analysis of pesticide residues: Recommended methods

World Health Organization 2011, Quality control methods for herbal materials, General advice on sampling

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 https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
root
main underground part of a plant that can branch
3.2
root stock
top part of the dried main root (3.1), which is closest to the stem
3.3
total ash
residue obtained after incineration at 525 °C ± 25 °C
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ISO 22584:2019(E)
3.4
acid-insoluble ash
part of the total ash (3.3) remaining after treatment with hydrochloric acid
4 Description
Angelica sinensis root is shown in Figure 1.
Key
A Angelica sinensis plant
B Angelica sinensis dried root
1 leaf
2 flowering branch
3 root stock
4 branching root
Figure 1 — Structure of Angelica sinensis (Oliv.) Diels
5 Requirements
5.1 General characteristics

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

a) Angelica sinensis root shall be clean and free from foreign matter.

b) The presence of living insects, mould and external contaminants which are visible to the naked eye

shall not be permitted.
5.2 Morphological features of Angelica sinensis root
a) The root is slightly cylindrical.

b) The outer surface is yellowish brown to reddish brown with longitudinal wrinkles and transversely

elongated lenticels.
2 © ISO 2019 – All rights reserved
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ISO 22584:2019(E)
c) The root s
...

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