ISO 19025:2024
(Main)Traditional Chinese medicine — Glycyrrhiza uralensis, Glycyrrhiza inflata, and Glycyrrhiza glabra root and rhizome
Traditional Chinese medicine — Glycyrrhiza uralensis, Glycyrrhiza inflata, and Glycyrrhiza glabra root and rhizome
This document specifies the quality and safety requirements for Glycyrrhiza root and rhizome that is derived from the root and rhizome of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat or Glycyrrhiza glabra L. (Fam. Fabaceae). This document applies to Glycyrrhiza root and rhizome that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
Médecine traditionnelle chinoise — Rhizome et racine de Glycyrrhiza uralensis, Glycyrrhiza inflata et Glycyrrhiza glabra
General Information
Standards Content (Sample)
International
Standard
ISO 19025
First edition
Traditional Chinese medicine —
2024-12
Glycyrrhiza uralensis, Glycyrrhiza
inflata, and Glycyrrhiza glabra root
and rhizome
Médecine traditionnelle chinoise — Rhizome et racine de
Glycyrrhiza uralensis, Glycyrrhiza inflata et Glycyrrhiza glabra
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 . 1
5 Requirements and recommendations . 3
5.1 General characteristics .3
5.2 Morphological characteristics .4
5.3 Microscopic characteristics .4
5.4 Moisture .6
5.5 Total ash .6
5.6 Acid-insoluble ash .7
5.7 Thin-layer chromatogram identification .7
5.8 Marker compounds .7
5.9 Heavy metals .7
5.10 Pesticide residues .7
6 Sampling . 7
7 Test methods . 7
7.1 Macroscopic identification .7
7.2 Determination of moisture content .7
7.3 Determination of total ash content .7
7.4 Determination of acid-insoluble ash .7
7.5 Thin-layer chromatogram identification .7
7.6 Determination of marker compounds .7
7.7 Determination of heavy metals content .8
7.8 Determination of pesticide residues content .8
8 Test report . 8
9 Packaging, storage and transportation . 8
10 Marking and labelling . 8
Annex A (informative) Thin-layer chromatogram identification test . 9
Annex B (informative) Determination of marker compounds by HPLC-UV .11
Annex C (informative) Reference information of national and regional requirements .13
Bibliography .15
iii
Foreword
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This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
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iv
Introduction
Glycyrrhizae root and rhizoma, also known as Guolao, Lingtong, Sweet grass and Lolium, is the dried root
and rhizome of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat or Glycyrrhiza glabra L. It is included
in the Pharmacopoeia of the People's Republic of China, the Japanese Pharmacopoeia, the United States
Pharmacopoeia, Korea Pharmacopoeia and European Pharmacopoeia. It has been widely used as an
important medicinal herb around the world, such as in China, Japan, Turkey, Greece and Egypt. It’s one of
the oldest Chinese medicinal herbs which has high levels of bioactive phytochemicals. In ancient times,
it was commonly used to treat oral ulcers, indigestion, and hemorrhoids. Besides, this plant has multiple
pharmacological properties, including anti-inflammatory, antiviral, antimicrobial, antioxidative, anticancer,
and antidiabetic effects.
Licorice products are mainly derived from cultivated Glycyrrhizae root and rhizoma plants from China
or other Asian countries. For licorice, different extracts have different effects and, in some cases, do not
have any effects. Therefore, consistent quality of Glycyrrhizae root and rhizoma cultivated is a prerequisite
to ensure safety and efficacy in its preparations and production. However, wide variations in bioactive
components contents of Glycyrrhizae root and rhizoma cultivated were observed, which are influenced by
various factors, such as genetic differences, environmental factors, and agronomic practices. In addition,
different countries, such as China, Japan and the United States, have different quality standards for the
quality markers or other components about Glycyrrhizae root and rhizoma.
The establishment of an international standard for Glycyrrhizae root and rhizoma is therefore necessary to
support its quality consistency, clinical effectiveness, and safety in international trade.
As national implementation may differ, national standards bodies are invited to modify the values given in
5.4, 5.5, and 5.6 in their national standards. Examples of national and regional values are given in Annex C.
v
International Standard ISO 19025:2024(en)
Traditional Chinese medicine — Glycyrrhiza uralensis,
Glycyrrhiza inflata, and Glycyrrhiza glabra root and rhizome
1 Scope
This document specifies the quality and safety requirements for Glycyrrhiza root and rhizome that is derived
from the root and rhizome of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat or Glycyrrhiza glabra L.
(Fam. Fabaceae).
This document applies to Glycyrrhiza root and rhizome that is sold and used as natural medicines 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 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 22217:2020, 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 23723:2021, 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 .electropedia .org/
3.1
Glycyrrhiza root and rhizome
dried root and rhizome of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat o
...
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