ISO 25657
(Main)Traditional Chinese medicine — Curculigo orchioides rhizome
- Abstract
This document specifies the quality and safety requirements and test methods of Curculigo orchioides rhizome, which is derived from the root of Curculigo orchioides Gaertn. (Fam. Amaryllidaceae). This document is applicable to Curculigo orchioides rhizome that are sold and used as natural medicines in international trade, including Chinese Materia Medica (whole medicinal material) and decoction pieces derived from this plant.
- Status
- Not Published
- Technical Committee
- ISO/TC 249 - Traditional Chinese medicine
- Current Stage
- 6000 - International Standard under publication
- Start Date
- 03-Sep-2026
- Completion Date
- 10-Oct-2026
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ISO/FDIS 25657 - Traditional Chinese medicine — Curculigo orchioides rhizome
REDLINE ISO/FDIS 25657 - Traditional Chinese medicine — Curculigo orchioides rhizome
ISO 25657 is an International Standard from ISO for the dried rhizome of Curculigo orchioides Gaertn. It specifies quality and safety requirements and test methods for material sold and used as natural medicine in international trade, including Chinese materia medica and decoction pieces. The document combines identity checks, chemical tests and handling requirements so suppliers, labs and buyers can judge whether a batch matches the standard.
What does ISO 25657 specify?
ISO 25657 covers the quality and safety of Curculigo orchioides rhizome and the methods used to verify it. It focuses on dried rhizome material used as a natural medicine, rather than on the growing plant.
The document is organized into clauses for scope, normative references, terms and definitions, descriptions, requirements and recommendations, sampling, test methods, test report, packaging, storage and transportation, and marking and labelling. It then adds four informative annexes with identification and assay methods plus reference values from other standards.
| Annex | What it covers |
|---|---|
| Annex A | Thin-layer chromatogram (TLC) identification |
| Annex B | Determination of the curculigoside content |
| Annex C | Determination of the orcinol glucoside content |
| Annex D | Reference values in different national and regional standards |
What are the key requirements of ISO 25657?
ISO 25657 sets out both physical acceptance criteria and analytical checks. In practice, a supplier or laboratory uses these to confirm identity, screen for contamination and document batch quality before trade or use.
Identity and appearance
Clause 5.1 requires the rhizome to be clean, with no leaves, stem or visible foreign matter. Living insects, mouldy rhizome and visible external contaminants are not permitted. This is the first incoming-inspection filter and helps reject obviously unsuitable material early.
Clause 5.2 describes the material as cylindrical and slightly curved, with a brownish rough surface, fine rootlet scars and transverse wrinkles. It also gives the expected length, diameter, fracture appearance, odour and taste. In practice, these features support visual sorting and help distinguish authentic material from look-alikes.
Clause 5.3 gives microscopic features for the transverse section and powder, including cork cells, cortex structure, calcium oxalate crystals, mucilage cells, starch grains and spiral vessels. These features matter when the material is cut, powdered or otherwise hard to identify by eye alone.
Quality and safety limits
Clauses 5.4 to 5.6 set limits for moisture, total ash and ethanol-soluble extractives. The standard also notes that national standards bodies may adapt the values for these items, and Annex D shows examples from other national and regional standards. For buyers and quality managers, these are the main bulk-quality checks for stability, cleanliness and extractable material.
Clause 5.7 requires TLC identification to show a spot or band with the same colour and position as the reference solution. Annex A gives the procedure and typical chromatograms. This is a practical identity test for routine release and dispute checking.
Clause 5.8 calls for determination of marker compound(s), named as curculigoside and orcinol glucoside. Annex B and Annex C provide HPLC methods for these compounds. This supports chemical profiling of the rhizome, not just visual identification.
Clause 5.9 requires determination of heavy metals, including arsenic, mercury, lead and cadmium, and Clause 5.10 requires determination of pesticide residues, including DDT, endrin, BHC, aldrin and dieldrin. These checks are important for safety assessment and for meeting import or customer specifications.
Sampling, testing and reporting
Clause 6 says sampling of raw and processed rhizomes follows ISO 23723:2021, Clause 8. Clause 7.1 requires at least 500 g from each batch for macroscopic identification, examined by sight in sunlight and checked by smell and taste. That gives a consistent starting sample for batch release.
Clause 7 links most laboratory work to other ISO methods: microscopic examination, moisture, ash, water-soluble extractives, heavy metals and pesticide residues. Clause 8 then requires the test report to identify the sample, state the sampling and test methods used, give the results, record any unusual operating details or anomalies, and show the test date.
Packaging and labelling
Clause 9 requires packaging and transport to avoid odour transfer, damage and health risks, and to protect the product from light, moisture, pollution and foreign substances. Clause 10 requires package marking or labelling with the quality features from Clause 5, the mass details, origin, production and expiry dates, storage method and any destination-country regulatory items. For trade, this is the information that follows the batch through warehousing and cross-border shipment.
What terms does ISO 25657 define?
- Curculigo orchioides rhizome - the dried rhizome of Curculigo orchioides Gaertn. (Fam. Amaryllidaceae).
- Thin-layer chromatogram (TLC) - the identification approach used in Clause 5.7 and Annex A to compare sample spots with reference material.
- High-performance liquid chromatography (HPLC) - the method used in Annex B and Annex C to determine curculigoside and orcinol glucoside.
- Chemical reference substance (CRS) - the reference substance used to prepare the comparison solution in Annex A.
- Marker compound(s) - the named chemical indicators used for assay, here curculigoside and orcinol glucoside.
- Heavy metals - the safety-related group of elements checked in Clause 5.9, including arsenic, mercury, lead and cadmium.
- Pesticide residues - the residue group checked in Clause 5.10, including DDT, endrin, BHC, aldrin and dieldrin.
Who uses ISO 25657?
ISO 25657 is used by producers, processors, traders, laboratories, importers, exporters and buyers of Curculigo orchioides rhizome. It is also relevant to quality control staff and inspectors who need to confirm identity, check contamination and document conformity for natural medicine trade.
The standard is aimed at Chinese materia medica and decoction pieces derived from this plant. It is therefore most useful where batches are bought, tested, labelled and shipped as herbal raw material rather than sold as a finished medicine.
Which standards are used with ISO 25657?
- ISO 23723:2021 - provides the general requirements for herbal raw material and materia medica, and Clause 6 uses it for sampling; Clause 7 also uses it for moisture, ash and water-soluble extractives.
- ISO/TS 21310 - provides the microscopic examination method used in Clause 7.2.
- ISO 18664 - provides the heavy-metals test method used in Clause 7.8.
- ISO 22258 - provides the pesticide-residues test method used in Clause 7.9.
- ISO 22217 - provides the storage requirements referenced in Clause 9.
What does the ISO 25657 document contain?
The document includes a descriptive section with the plant and rhizome structure, shown in Figure 1, and microscopic features shown in Figure 2. It also includes a TLC procedure in Annex A with preparation steps, plate conditions, mobile phase and a typical chromatogram.
Annex B and Annex C each give an HPLC-based assay method: sample preparation, recommended column and mobile phase conditions, detector settings and a calculation formula, together with typical chromatograms. Annex D provides a comparison table of reference values used in different national and regional standards, which is useful when aligning local specifications with the ISO document.
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ISO/FDIS 25657 - Traditional Chinese medicine — Curculigo orchioides rhizome
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Frequently Asked Questions
ISO 25657 is a draft published by the International Organization for Standardization (ISO). Its full title is "Traditional Chinese medicine — Curculigo orchioides rhizome". This standard covers: This document specifies the quality and safety requirements and test methods of Curculigo orchioides rhizome, which is derived from the root of Curculigo orchioides Gaertn. (Fam. Amaryllidaceae). This document is applicable to Curculigo orchioides rhizome that are sold and used as natural medicines in international trade, including Chinese Materia Medica (whole medicinal material) and decoction pieces derived from this plant.
This document specifies the quality and safety requirements and test methods of Curculigo orchioides rhizome, which is derived from the root of Curculigo orchioides Gaertn. (Fam. Amaryllidaceae). This document is applicable to Curculigo orchioides rhizome that are sold and used as natural medicines in international trade, including Chinese Materia Medica (whole medicinal material) and decoction pieces derived from this plant.
ISO 25657 is classified under the following ICS (International Classification for Standards) categories: 11.120.10 - Medicaments. The ICS classification helps identify the subject area and facilitates finding related standards.
ISO 25657 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
FINAL DRAFT
International
Standard
ISO/FDIS 25657
ISO/TC 249/SC 1
Traditional Chinese medicine —
Secretariat: SAC
Curculigo orchioides rhizome
Voting begins on:
Médecine traditionnelle chinoise — Rhizome de Curculigo 2026-07-08
orchioides
Voting terminates on:
2026-09-02
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO/FDIS 25657:2026(en) © ISO 2026
FINAL DRAFT
ISO/FDIS 25657:2026(en)
International
Standard
ISO/FDIS 25657
ISO/TC 249/SC 1
Traditional Chinese medicine —
Secretariat: SAC
Curculigo orchioides rhizome
Voting begins on:
Médecine traditionnelle chinoise — Rhizome de Curculigo
orchioides
Voting terminates on:
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2026
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/FDIS 25657:2026(en) © ISO 2026
ii
ISO/FDIS 25657:2026(en)
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 . 2
5.1 General .2
5.2 Morphological features .2
5.2.1 Appearance .2
5.2.2 Colour .3
5.2.3 Dimensions .3
5.2.4 Texture .3
5.2.5 Odour and taste .3
5.3 Microscopical characteristics .3
5.4 Moisture .4
5.5 Total ash .4
5.6 Ethanol-soluble extractives .4
5.7 Thin-layer chromatogram (TLC) identification .4
5.8 Marker compound(s) .5
5.9 Heavy metals .5
5.10 Pesticide residues .5
6 Sampling . 5
7 Test method . 5
7.1 Macroscopic identification .5
7.2 Microscopical identification .5
7.3 Determination of the moisture content .5
7.4 Determination of the total ash content .5
7.5 Water-soluble extractives .5
7.6 Thin-layer chromatogram (TLC) identification .5
7.7 Determination of marker compound(s).5
7.8 Determination of heavy metals contents .5
7.9 Determination of pesticide residues contents.5
8 Test report . 6
9 Packaging, storage and transportation . 6
10 Marking and labelling . 6
Annex A (informative) Thin-layer chromatogram (TLC) identification . 7
Annex B (informative) Determination of the curculigoside content . 9
Annex C (informative) Determination of the orcinol glucoside content .11
Annex D (informative) Reference values of the Curculigo orchioides rhizome in different
national and regional standards .13
Bibliography . 14
iii
ISO/FDIS 25657:2026(en)
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
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. 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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
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.
iv
ISO/FDIS 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 to 300
tons of Curculigo orchioides rhizome have been exported to Japan, Korea, Hongkong of China and other
countries and regions every year. In addition, between 2017 and 2022, 1 000 tons 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]
pharmacopoeia of many countries and regions, such as the Chinese Pharmacopoeia (2025 edition) ,
th [2]
the Korean Herbal Pharmacopoeia (4 edition) , the Hong Kong Chinese Materia Medica Standards (Volume
[3] [4]
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
[5]
medicines for developing standards, as defined in 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 5.4, 5.5
and 5.6 to adapt to their national standards. Examples of national and regional values are given in Annex D.
v
FINAL DRAFT International Standard ISO/FDIS 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 examinatio
...
Style Definition: List Continue 1: Indent: Left: 0 cm,
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
VVVoootttiiing bng bng beeegigiginsnsns o o on:n:n: 202 202 202555---111111---030303
VoVoVotintintinggg t t terererminminminatatateseses o o onnn::: 222000222666---000111---262626
ISO/DISFDIS 25657:2026(en)
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication
may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying,
or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO
at the address below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
Formatted: French (France)
E-mail: copyright@iso.org
Website: www.iso.org
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
iv
ISO/DISFDIS 25657:2026(en)
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
ISO technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. 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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights
in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s)
which may be required to implement this document. However, implementers are cautioned that this may not
represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
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.
vi
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.
Formatted: Numbered + Level: 1 + Numbering Style: a,
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.
Formatted: Numbered + Level: 1 + Numbering Style: a,
b,
...