ISO 22584:2019
(Main)Traditional Chinese medicine — Angelica sinensis root
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
Standards Content (Sample)
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)
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© ISO 2019
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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
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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
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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
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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.
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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.
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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.
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ISO 22584:2019(E)
c) The root s
...
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