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International
Standard
ISO 13615
First edition
Traditional Chinese medicine —
2024-07
Atractylodes macrocephala rhizome
Médecine traditionnelle chinoise — Rhizome d'Atractylodes
macrocephala
Reference number
© ISO 2024
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ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Descriptions . 2
5 Quality and safety requirements and recommendations . 3
5.1 General characteristics .3
5.2 Morphological features .3
5.2.1 Atractylodes macrocephala rhizome .3
5.2.2 Decoction pieces .3
5.3 Identification .3
5.3.1 Thin-layer chromatography (TLC) identification .3
5.3.2 High performance liquid chromatography (HPLC) identification .3
5.4 Moisture .3
5.5 Total ash .4
5.6 Sulfur dioxide residues . . .4
5.7 Ethanol-soluble extractives .4
5.8 Essential oil.4
5.9 Heavy metals .4
5.10 Pesticide residues .4
6 Sampling . 4
7 Test methods . 4
7.1 Macroscopic identification .4
7.2 Thin-layer chromatography (TLC) identification .4
7.3 High performance liquid chromatography (HPLC) identification.4
7.4 Determination of moisture content .4
7.5 Determination of total ash content .4
7.6 Determination of sulfur dioxide residues content .4
7.7 Determination of ethanol-soluble extractives content .5
7.8 Determination of essential oil content .5
7.9 Determination of heavy metals content .5
7.10 Determination of pesticide residues content .5
8 Test report . 5
9 Packaging, storage and transportation . 5
10 Marking and labelling . 5
Annex A (informative) Thin-layer chromatography (TLC) identification . 6
Annex B (informative) High performance liquid chromatography (HPLC) identification . 8
Annex C (informative) Reference values of national and regional limits .11
Bibliography .12
iii
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
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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 document should be noted. This document was drafted in accordance with the editorial rules of the
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This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
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iv
Introduction
Atractylodes macrocephala rhizome, the dried rhizome of Atractylodes macrocephala Koidz., is a widely
used herbal medicine in China and many other countries. In traditional Chinese medicine, this herb can
tonify the Spleen-Qi, and is used to treat distension in the abdomen, loose stools, and diarrhoea. Modern
pharmacological studies also demonstrate its great potential in immuno-enhancement and indigestion
treatment. The market, yield, and trade volume of Atractylodes macrocephala rhizome are large and develop
rapidly in recent years.
Atractylodes macrocephala rhizome has been recorded in several pharmacopoeias, including Chinese
[1] [2] [3] [4]
Pharmacopoeia , European Pharmacopoeia , Korean Pharmacopoeia , Japanese Pharmacopoeia and
[5]
Hong Kong Chinese Materia Medical Standards . The requirements and specifications in these standards
have differences. Therefore, it is important to develop an International Standard for harmonizing the
existing standards, as well as ensuring the safety and effectiveness of Atractylodes macrocephala rhizome,
which can benefit farmers, consumers, enterprises and governments involved in the cultivation, regulation
and trade of Atractylodes macrocephala rhizome.
As national implementation may differ, national standards bodies are invited to modify the values given in
5.4 and 5.5 in their national standards. Examples of national and regional values are given in Annex C.
v
International Standard ISO 13615:2024(en)
Traditional Chinese medicine — Atractylodes
macrocephala rhizome
1 Scope
This document specifies requirements and test methods for Atractylodes macrocephala rhizome that is
derived from Atractylodes macrocephala Koidz.
It is applicable to Atractylodes macrocephala rhizome that is sold and used as a natural medicine in
international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces
derived from the 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 18664, Traditional Chinese Medicine — Determination of heavy metals in herbal medicines used in
Traditional Chinese Medicine
ISO 21371, Traditional Chinese medicine — Labelling requirements of products intended for oral or topical use
ISO 22217, Traditional Chinese medicine —Storage requirements for raw materials and decoction pieces
ISO 22258, Traditional Chinese medicine — Determination of pesticide residues in natural products by gas
chromatography
ISO 22590, Traditional Chinese medicine — Determination of sulfur dioxide in natural products by titration
ISO 23723, Traditional Chinese medicine — General requirements for herbal raw material and materia medica
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 .elect
...