ISO 25657

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ISO/DISFDIS 25657
Hanging: 0.63 cm, Bulleted + Level: 1 + Aligned at: 0
cm + Indent at: 0.63 cm
ISO/TC 249/SC 1
Formatted: French (France)
Secretariat: SAC
Formatted: French (France)
Date: 2026-01-2706-19
Formatted: English (United States)
Formatted: English (United States)
Formatted: English (United States)
Traditional Chinese medicine — Curculigo orchioides rhizome
Formatted: English (United States)
DISMédecine traditionnelle chinoise — Rhizome de Curculigo orchioides
Formatted: English (United States)
FDIS stage
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VoVoVotintintinggg t t terererminminminatatateseses o o onnn:::  222000222666---000111---262626

ISO/DISFDIS 25657:2026(en)
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Published in Switzerland
ii
ISO/DISFDIS 25657:2026(en)
Contents
Foreword . iii
Introduction . iii
Scope . iii
Normative references . iii
Terms and definitions . iii
Descriptions . iii
Requirements and recommendations . iii
General . iii
Morphological features . iii
Microscopical characteristics . iii
Moisture . iii
Total ash . iii
Ethanol-soluble extractives . iii
Thin-layer chromatogram (TLC) identification . iii
Marker compound(s) . iii
Heavy metals . iii
Pesticide residues . iii
Sampling . iii
Test method . iii
Macroscopic identification . iii
Microscopical identification . iii
Determination of the moisture content . iii
Determination of the total ash content . iii
Water-soluble extractives . iii
Thin-layer chromatogram (TLC) identification . iii
Determination of marker compound(s) . iii
Determination of heavy metals contents . iii
Determination of pesticide residues contents . iii
Test report . iii
Packaging, storage and transportation . iii
Marking and labelling . iii
(informative) Thin-layer chromatogram (TLC) identification . iii
(informative) Determination of the curculigoside content . iii
(informative) Determination of the orcinol glucoside content . iii
(informative) Reference values of Curculigo orchioides rhizome in different national and
regional standards . iii
Bibliography . iii
Foreword . v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
iii
ISO/DISFDIS 25657:2026(en)
4 Descriptions . 1
5 Requirements and recommendations . 3
5.1 General . 3
5.2 Morphological features . 3
5.3 Microscopical characteristics . 3
5.4 Moisture . 6
5.5 Total ash . 6
5.6 Ethanol-soluble extractives. 6
5.7 Thin-layer chromatogram (TLC) identification . 6
5.8 Marker compound(s). 6
5.9 Heavy metals . 6
5.10 Pesticide residues . 6
6 Sampling . 6
7 Test method . 6
7.1 Macroscopic identification . 6
7.2 Microscopical identification . 7
7.3 Determination of the moisture content . 7
7.4 Determination of the total ash content . 7
7.5 Water-soluble extractives . 7
7.6 Thin-layer chromatogram (TLC) identification . 7
7.7 Determination of marker compound(s) . 7
7.8 Determination of heavy metals contents . 7
7.9 Determination of pesticide residues contents . 7
8 Test report . 7
9 Packaging, storage and transportation . 8
10 Marking and labelling . 8
Annex A (informative) Thin-layer chromatogram (TLC) identification . 9
Annex B (informative) Determination of the curculigoside content . 11
Annex C (informative) Determination of the orcinol glucoside content . 16
Annex D (informative) Reference values of the Curculigo orchioides rhizome in different
national and regional standards . 20
Bibliography . 23

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ISO/DISFDIS 25657:2026(en)
Foreword
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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
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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 medicine, Subcommittee SC 1,
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.
v
ISO/DISFDIS 25657:2026(en)
Introduction
The Curculigo orchioides rhizome is the dried rhizome of Curculigo orchioides Gaertn. (Fam. Amaryllidaceae),
which is known as Xian Mao (仙茅) in Chinese pinyin, Curculiginis, Kali Musli available in international
markets, which has a long history of medicinal use and a wide range of clinical applications in China, Japan,
Korea, Vietnam, Myanmar, India and other East Asian countries. The Curculigo orchioides rhizome is
considered to have attributes beneficial to the kidney and liver channels, and it is traditionally valued and
reported for treating impotence, limb limpness, arthritis of the lumbar and knee joints and watery diarrhea.
The Curculigo orchioides rhizome has a complex chemical composition, including various constituents such as
phenols and phenolic glucosides, norlignans, terpenoids, alkaloids and flavones. Modern pharmacological
studies have reported that phenols and phenolic glucosides, norlignans and terpenoids are the main active
constituents in the Curculigo orchioides rhizome for enhancing adaptive effects, increasing
immunomodulation, having anti-oxidant, anti-osteoporosis, hepatoprotective, oestrogenic activities and
effects on sexual behaviour.
In global trade, based on Chinese customs data, there is a relatively large demand for Curculigo orchioides
rhizomes in the Chinese Materia Medica market at home and abroad. Between 2017 and 2022, 200 ttoto 300
t ()tons of Curculigo orchioides rhizomesrhizome have been exported to Japan, Korea, Hongkong of China and
other countries and regions every year. In addition, between 2017 and 2022, 1 000 toftons of Curculigo
orchioides rhizomes have been imported from Myanmar and Vietnam every year.
As a globally used herbal medicine, the Curculigo orchioides rhizome has been widely used in polyherbal
formulations of Traditional Chinese, Kampo and Indian medicines. It has also been included in the
[1] [1]
pharmacopoeia of many countries and regions, such as the Chinese Pharmacopoeia (20202025 edition) ,) ,
th [2] [2]
the Korean Herbal Pharmacopoeia (4 edition) ,) , the Hong Kong Chinese Materia Medica
[3] [3] [4] [4]
Standards (Volume 4) ) and the Ayurveda Pharmacopeia of India (Part I, Volume 4) .) . However,
specifications and quality requirements in these standards are not unified due to the lack of an International
Standard for the Curculigo orchioides rhizome.
Additionally, the quality of the Curculigo orchioides rhizome provided from different areas varies a lot. The
Curculigo orchioides rhizome is ranked as a relatively high priority in the priority list of single herbal medicines
[5]
for developing standards, as defined in ISO/TR 23975 .ISO/TR 23975:2025. Thus, there is a clear and urgent
need to develop an International Standard for harmonizing these existing standards, as well as ensuring the
safety and effectiveness of the Curculigo orchioides rhizome.
As national implementations can differ, national standards bodies can modify the values given in 5.65.4, 5.5
and 5.85.6 to adapt to their national standards. Examples of national and regional values are given in Annex
D.Annex D.
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ISO/DISFDIS 25657:2026(en)
Traditional Chinese medicine — Curculigo orchioides rhizome
1 Scope
This document specifies the quality and safety requirements and test methods for the Curculigo
orchioides rhizome, which is derived from the dried rhizome of Curculigo orchioides Gaertn. (Fam.
Amaryllidaceae).
This document is applicable to Curculigo orchioides rhizomes that are 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/TS 21310, Traditional Chinese medicine — Microscopic examination of medicinal herbs
ISO 2131721371, Traditional Chinese medicine — Lonicera japonica flowerLabelling 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 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
Formatted: List Continue 1
— — IEC Electropedia: available at https://www.electropedia.org/
3.1
Curculigo orchioides rhizome
Formatted: Font: Bold
dried rhizome of Curculigo orchioides Gaertn. (Fam. Amaryllidaceae)
4 Descriptions
In this document, the structure of Curculigo orchioides Gaertn. (Fam. Amaryllidaceae) and the dried rhizome
are shown in Figure 1.Figure 1.
ISO/DISFDIS 25657:2026(en)
b)  rhizome of Curculigo orchioides rhizome
Formatted: Figure subtitle
Gaertn.
ISO/DISFDIS 25657:2026(en)
a) Plant plant of Curculigo orchioides Gaertn.
Formatted: Font: Italic
Formatted: Figure subtitle
Key
1 leaf
2 rhizome
3 flower
4 length
5 diameter
Figure 1 — Structure of the plant and rhizome of Curculigo orchioides Gaertn.
5 Requirements and recommendations
5.1 General
The following requirements shall be met before the sampling in accordance with Clause 6.Clause 6.
a) The Curculigo orchioides rhizome shall be clean and free from leaves, stem and foreign matter.
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b, c, … + Start at: 1 + Alignment: Left + Aligned at: 0
b) The presence of living insects, mouldy rhizome and external contaminants which are visible to the naked cm + Indent at: 0 cm
eye shall not be permitted.
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b,
...