ISO 24900:2026

International
Standard
ISO 24900
First edition
Traditional Chinese medicine —
2026-08
Sophora tonkinensis root and
rhizome
Médecine traditionnelle chinoise — Racine et rhizome de
Sophora tonkinensis
Reference number
© ISO 2026
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Published in Switzerland
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Description . . 2
5 Requirements and recommendations . 2
5.1 General characteristics .2
5.2 Morphological features of root and rhizome .3
5.3 Microscopic identification .3
5.4 Thin-layer chromatogram (TLC) identification .3
5.5 Moisture .3
5.6 Total ash .4
5.7 Ethanol-soluble extractives .4
5.8 Heavy metals .4
5.9 Pesticide residues .4
5.10 Marker compounds .4
6 Sampling . 4
7 Test methods . 4
7.1 Macroscopic identification .4
7.2 Microscopic identification .4
7.3 Thin-layer chromatogram (TLC) identification .4
7.4 Determination of moisture .4
7.5 Determination of total ash .4
7.6 Determination of ethanol-soluble extractives .4
7.7 Determination of heavy metals .4
7.8 Determination of pesticide residues .5
7.9 Determination of marker compounds .5
8 Test report . 5
9 Packaging, storage and transportation . 5
10 Marking and labelling . 5
Annex A (informative) Thin-layer chromatogram (TLC) identification . 6
Annex B (informative) Determination of marker compounds by HPLC-UV . 8
Annex C (informative) Reference information for national and regional requirements .10
Bibliography .13

iii
Foreword
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This document was prepared by Technical Committee ISO/TC 249, Traditional medicine, Subcommittee SC 1,
Traditional Chinese medicine.
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iv
Introduction
Sophora tonkinensis root and rhizome (the Chinese Pinyin name: Shandougen) is the dried root and rhizome
of Sophora tonkinensis Gagnep. (Fam. Leguminosae). It is mainly produced in southwest China and Vietnam,
belongs to one of the toxic traditional Chinese medicines. Sophora tonkinensis root and rhizome is first
[1]
recorded in "Kaibao Bencao" in the Song Dynasty, and called "solution throat swelling first medicine" in
[2]
"Becao Qiuzhen" in the Qing Dynasty .
Sophora tonkinensis root and rhizome can clear heat and detoxify, reduce swelling and enhance pharynx.
It demonstrates anti-tumour, anti-inflammation, anti-oxidation, antibacterial and immunity-enhancing
effects. It is often used in the clinical treatment of pharyngitis and tonsillitis, and its preparations are also
used in the treatment of chronic hepatitis and liver cancer as adjuvant therapy.
More than 200 compounds have been identified from the Sophora tonkinensis root and rhizome, mainly
include alkaloids, flavonoids, triterpenoids, triterpenoid saponins, and polysaccharides, where alkaloids
both serve as the important material basis for the pharmacodynamic action and the main substances causing
toxicity. The adverse events induced by Sophora tonkinensis root and rhizome and its alkaloids include nerve
injury, hepatic injury, cardiovascular injury, kidney injury and reproductive injury, and gastrointestinal
reaction. Quinolizidine alkaloids are the main toxic components, mainly including matrine, oxymatrine,
cytisine, sophocarpine, oxysophocarpine, sophoridine, sophoramine, and lehmannine. The mechanism of
toxicity needs further study. Because of the coexisting of its efficacy and poison, long-term or high-dose
administration often leads to a series of safety problems in the clinical application process.
At present, the quality of Sophora tonkinensis root and rhizome varies greatly. It is mainly represented by
the substitution of other varieties in medicine, such as Menispermun dauricum, Indigofera fortunei, Mogjanin
philippinensis. There are also the above-ground parts (non-medicinal parts) adulterated with Sophora
tonkinensis sold as Sophora tonkinensis root and rhizome.
Moreover, Sophora tonkinensis root and rhizome is ranked no. 54 in the priority list of single herbal medicines
[3]
for developing standards in ISO/TR 23975. Therefore, it is necessary to standardize the quality and safety
control of Sophora tonkinensis root and rhizome, so as to provide reference for studying the toxicity of
Sophora tonkinensis root and rhizome.
As national implementation can differ, national standards bodies are invited to modify the values given in
5.6 and 5.10 in their national standards. Examples of national and regional values are given in Annex C.

v
International Standard ISO 24900:2026(en)
Traditional Chinese medicine — Sophora tonkinensis root and
rhizome
1 Scope
This document specifies the minimum requirements and test methods for Sophora tonkinensis root and
rhizome.
This document applies to Sophora tonkinensis root and rhizome sold and used as 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/TS 21310, Traditional Chinese medicine — Microscopic examination of medicinal herbs
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
Sophora tonkinensis root and rhizome
dried root and rhizome of Sophora tonkinensis Gagnep. (Fam. Leguminosae)
3.2
marker compo
...