ISO 25661
(Main)Traditional Chinese medicine — Polygonatum kingianum, Polygonatum sibiricum, and Polygonatum cyrtonema rhizome
- Abstract
This document specifies the minimum requirements and test methods for Polygonati rhizome, which is derived from the plant of Polygonatum kingianum Coll.et Hemsl., Polygonatum sibiricum Red., and Polygonatum cyrtonema Hua (Fam. Liliaceace). This document is applicable to Polygonati rhizome that is sold and used as herbal raw materials in the international trade, including Chinese materia medica (whole medicinal materials) 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
- 10-Sep-2026
- Completion Date
- 10-Oct-2026
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ISO/FDIS 25661 - Traditional Chinese medicine — Polygonatum kingianum, Polygonatum sibiricum, and Polygonatum cyrtonema rhizome
REDLINE ISO/FDIS 25661 - Traditional Chinese medicine — Polygonatum kingianum, Polygonatum sibiricum, and Polygonatum cyrtonema rhizome
ISO 25661 is an ISO standard for Traditional Chinese medicine - Polygonatum kingianum, Polygonatum sibiricum, and Polygonatum cyrtonema rhizome. It specifies minimum requirements and test methods for Polygonati rhizome used as herbal raw material in international trade, including Chinese materia medica and decoction pieces. It is written for people who need a common basis for identification, quality control, sampling, test reporting, storage, and labelling.
What does ISO 25661 specify?
ISO 25661 specifies how to recognize Polygonati rhizome, what quality and safety characteristics to check, and which test methods to use. It applies to the dried rhizome derived from the three named Polygonatum species and to material sold and used in international trade.
The document is organized into 10 clauses and 3 informative annexes.
| Annex | What it covers |
|---|---|
| Annex A | Thin-layer chromatogram (TLC) identification of Polygonati rhizome |
| Annex B | Determination of the solomonseal polysaccharides content |
| Annex C | Reference information of national and regional requirements on Polygonati rhizome |
Clauses 1 to 10 cover the scope, normative references, terms and definitions, descriptions, requirements and recommendations, sampling, test methods, test report, packaging, storage and transportation, and marking and labelling. In practice, this structure lets a user move from identification to testing to handling and documentation in one document.
What are the key requirements of ISO 25661?
ISO 25661 combines identity checks, quality limits, contaminant testing, and handling rules for traded Polygonati rhizome. The practical aim is to make sure a lot is the right plant material, is fit for use, and is described consistently.
Identity and appearance
Clauses 4 and 5.1 to 5.4 require the material to match the declared plant source and its characteristic appearance. The rhizome should be clean, free from fibrous roots and foreign matter, and it should not show living insects, mould, external contamination visible to the naked eye, or unpleasant and rancid odour.
For day-to-day receiving inspection, this means the lot can be screened first by sight and smell before laboratory work starts. Clause 5.2 describes the typical macroscopic features for Polygonatum kingianum, Polygonatum sibiricum, and Polygonatum cyrtonema, and Clause 5.3 gives the microscopic features seen in transverse section. Figure 1 and Figure 2 support this identification.
Chemical identification and quality checks
Clause 5.4 uses TLC to confirm identity by comparing the position and colour of spots with the herbal reference solution. Clause 5.9 requires determination of marker compounds, including solomonseal polysaccharides. In practice, this gives a chemical check that complements the appearance-based identification.
Clause 5.5 to 5.8 cover foreign matter, moisture, total ash, and extractives. These are the usual bulk-quality measures for herbal raw materials, so they help buyers and laboratories judge cleanliness, dryness, and overall material quality. Clause 5.7 sets total ash at not more than 5.0 % by mass.
Safety-related measurements
Clauses 5.10 to 5.13 require determination of heavy metals, sulfur dioxide, pesticide residues, and aflatoxins. Heavy metals include arsenic, mercury, lead, cadmium, and copper. Aflatoxins include aflatoxin B1, B2, G1, and G2.
For practical control, these checks address contamination from cultivation, processing, storage, or transport. They are especially relevant for importers, exporters, and quality laboratories that need evidence that a shipment meets food or herbal material safety expectations.
Sampling and test methods
Clause 6 says to sample according to ISO 23723:2021, Clause 8. Clause 7 then ties each measurement to a method, so the document is not just descriptive - it tells users how to test.
Clause 7.1 requires macroscopic identification on random samples of not less than 250 g, examined by naked eye in sunlight and smell. Clause 7.2 refers microscopic examination to ISO/TS 21310. Clause 7.3 and Annex A give the TLC procedure, Clause 7.8 and Annex B give the polysaccharides assay, and Clauses 7.9 to 7.12 refer the contaminant tests to ISO 18664, ISO 22590, ISO 22258, and ISO 22283. This matters because laboratories can follow named methods instead of developing their own.
Reporting, packaging, storage, and labelling
Clause 8 requires the test report to identify the sample, state the standard used, identify the sampling and test methods, give the results, record operating details and anomalies, and state the test date. That makes results traceable in trade, auditing, and dispute resolution.
Clause 9 requires storage and transport conditions in line with ISO 22217 and says the product should be kept in a normal-temperature, dry place, protected from light, moisture, pollution, and foreign substances. Clause 10 refers labelling to ISO 21371 and requires the product name, Latin scientific name, quality features, weights, origin, dates, batch number, expiry date, storage and transport methods, and any destination-country regulatory items.
What terms does ISO 25661 define?
- Polygonati rhizome - The dried rhizome of Polygonatum kingianum, Polygonatum sibiricum, and Polygonatum cyrtonema.
- Chinese materia medica - Whole medicinal materials used in traditional Chinese medicine trade.
- Decoction pieces - Processed pieces derived from the plant for medicinal use.
- TLC - Thin-layer chromatogram identification used to compare the test solution with a reference solution.
- Marker compounds - Chemical constituents used to support quality assessment, including solomonseal polysaccharides.
- Foreign matter - Unwanted material mixed with the herbal raw material.
- Heavy metals - Contaminants measured in the material, including arsenic, mercury, lead, cadmium, and copper.
- Aflatoxins - Fungal toxins that the standard requires users to measure in the material.
Who uses ISO 25661?
ISO 25661 is used by growers, processors, traders, importers, exporters, laboratory staff, and quality managers working with Polygonati rhizome. It is also useful for buyers and regulators who need a shared basis for identity checks, contaminant testing, sampling, and package labelling.
In practice, it supports batch acceptance, supplier specification, routine laboratory testing, and documentation for international trade. It is especially relevant where herbal raw materials are bought as whole medicinal materials or decoction pieces.
Which standards are used with ISO 25661?
ISO 25661 relies on several other ISO documents for methods and handling requirements:
- ISO 23723:2021 - gives general requirements for herbal raw material and materia medica, including sampling and several routine test methods used in Clauses 6 and 7.
- ISO/TS 21310 - provides the microscopic examination method used for Clause 7.2.
- ISO 21371 - provides labelling requirements used in Clause 10.
- ISO 22217 - provides storage requirements for raw materials and decoction pieces used in Clause 9.
- ISO 22258 - provides the gas chromatography method for pesticide residues used in Clause 7.11.
- ISO 22283 - provides the LC-FLD method for aflatoxins used in Clause 7.12.
- ISO 22590 - provides the titration method for sulfur dioxide used in Clause 7.10.
- ISO 18664 - provides the heavy metals determination method used in Clause 7.9.
What does the ISO 25661 document contain?
ISO 25661 contains a species description, macroscopic and microscopic identification guidance, and a set of quality requirements for traded Polygonati rhizome. It also includes a standard test-report checklist, storage and transport guidance, and labelling items for the package.
The informative annexes add practical laboratory material. Annex A gives a TLC procedure and a chromatogram comparison approach, Annex B gives a UV-visible spectrophotometric procedure and calculation for solomonseal polysaccharides, and Annex C summarizes national and regional requirement examples for comparison. Figure 1 shows the plant and rhizome structure, and Figure 2 shows the transverse section features used in identification.
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Frequently Asked Questions
ISO 25661 is a draft published by the International Organization for Standardization (ISO). Its full title is "Traditional Chinese medicine — Polygonatum kingianum, Polygonatum sibiricum, and Polygonatum cyrtonema rhizome". This standard covers: This document specifies the minimum requirements and test methods for Polygonati rhizome, which is derived from the plant of Polygonatum kingianum Coll.et Hemsl., Polygonatum sibiricum Red., and Polygonatum cyrtonema Hua (Fam. Liliaceace). This document is applicable to Polygonati rhizome that is sold and used as herbal raw materials in the international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
This document specifies the minimum requirements and test methods for Polygonati rhizome, which is derived from the plant of Polygonatum kingianum Coll.et Hemsl., Polygonatum sibiricum Red., and Polygonatum cyrtonema Hua (Fam. Liliaceace). This document is applicable to Polygonati rhizome that is sold and used as herbal raw materials in the international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
ISO 25661 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 25661 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 25661
ISO/TC 249/SC 1
Traditional Chinese medicine —
Secretariat: SAC
Polygonatum kingianum,
Voting begins on:
Polygonatum sibiricum, and
2026-07-15
Polygonatum cyrtonema rhizome
Voting terminates on:
2026-09-09
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 25661:2026(en) © ISO 2026
FINAL DRAFT
ISO/FDIS 25661:2026(en)
International
Standard
ISO/FDIS 25661
ISO/TC 249/SC 1
Traditional Chinese medicine —
Secretariat: SAC
Polygonatum kingianum,
Voting begins on:
Polygonatum sibiricum, and
Polygonatum cyrtonema rhizome
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 25661:2026(en) © ISO 2026
ii
ISO/FDIS 25661:2026(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Descriptions . 2
5 Requirements and recommendations . 4
5.1 General characteristics .4
5.2 Morphological features .4
5.3 Microscopic characteristics .5
5.4 Thin-layer chromatogram (TLC) identification .5
5.5 Foreign matter .5
5.6 Moisture .6
5.7 Total ash .6
5.8 Extractives .6
5.9 Marker compounds .6
5.10 Heavy metals .6
5.11 Sulfur dioxide . .6
5.12 Pesticide residues .6
5.13 Aflatoxins .6
6 Sampling . 6
7 Test methods . 6
7.1 Macroscopic identification .6
7.2 Microscopic examination .6
7.3 Thin-layer chromatogram (TLC) identification .6
7.4 Determination of foreign matters .6
7.5 Determination of the moisture content .7
7.6 Determination of the total ash content .7
7.7 Determination of the extractives content .7
7.8 Determination of the solomonseal polysaccharides content .7
7.9 Determination of the heavy metals content .7
7.10 Determination of the sulfur dioxide content .7
7.11 Determination of the pesticide residues content .7
7.12 Determination of the aflatoxins content .7
8 Test report . 7
9 Packaging, storage and transportation . 7
10 Marking and labelling . 8
Annex A (informative) Thin-layer chromatogram (TLC) identification of Polygonati rhizome . 9
Annex B (informative) Determination of the solomonseal polysaccharides content .10
Annex C (informative) Reference information of national and regional requirements on
Polygonati rhizome .11
Bibliography .13
iii
ISO/FDIS 25661:2026(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, 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 25661:2026(en)
Introduction
Polygonati rhizome (Huang Jing) is the dried rhizome of Polygonatum kingianum Collett & Hemsl.,
Polygonatum sibiricum Redouté, and Polygonatum cyrtonema Hua (Fam. Liliaceace). It is found in China,
Korea, Japan, Vietnam, Myanmar, Laos, Thailand, Mongolia, and eastern Siberia, Russia. The dried rhizome
of Polygonatum falcatum A. Gray is also used as Polygonati rhizome in Japanese Pharmacopoeia and Korean
Pharmacopoeia.
Polygonati rhizome has been commonly consumed as a health food supplement and in traditional Chinese
medicine (TCM) for thousands of years due to high nutritional and medicinal values. In Mingyi Bielu (220 AD
to 450 AD), a classic medical text from ancient China, Polygonati rhizome was recorded as one of extremely
valuable herbs. According to the traditional Chinese medicine theory, Polygonati rhizome has the functions
of tonifying the Qi and the Yin, strengthening the spleen, moistening the lung and tonifying the kidney.
Modern pharmacological studies have shown that Polygonati rhizome not only has the effects of lowering
blood sugar, lowering blood lipids, anti-oxidation, anti-cancer, anti-inflammation and antibacterial, but also
has the pharmacological effects of anti-fatigue, immune regulation and anti-aging. This is related to the rich
chemical components of Polygonati rhizome, such as polysaccharide, saponins, flavonoids, alkaloids and
amino acids. Along with a growing number of studies on Polygonati rhizome, various beneficial nutrients
within Polygonati rhizome are being proposed, including carbohydrate, dietary fibre, mineral, vitamin,
sugar, amino acid, fatty acid and protein. Thus, Polygonati rhizome is considered as a popular nutritious
food and herb worldwide.
Polygonati rhizome as a special medicinal and edible material, has a lot of international attention and
demand. Searching publications on Polygonati rhizome in the PubMed database for the past ten years reveals
that more than 25 countries and regions have carried out relevant research. The global average annual trade
volume of Polygonati rhizome from 2018 to 2022 was about 5 962 t, and the global average annual trade value
is about 57,43 million US dollars. The world's main export countries of Polygonati rhizome are concentrated
in China, Myanmar and India. Among them, China and Myanmar account for about 95,1 % of the world's
annual exports. The main import countries and regions of Polygonati rhizome are: Japan, South Korea, Hong
Kong, Taiwan, Vietnam, Malaysia, the United States, Singapore, Thailand, Germany, Ireland, France, New
Zealand, Spain, Canada, Australia, Italy, Indonesia, Sudan, the Netherlands, the Russian Federation, India, the
United Kingdom, etc. According to Chinese customs data, China's export trade volume of Polygonati rhizome
was 2 809 t (in 2018), 2 911 t (in 2019), 3 399 t (in 2020), 6 236 t (in 2021) and 7 001 t (in 2022) with an
annual average export trade value of about 45,57 million US dollars. The analysis of international trade data
shows that the growing demand for Polygonati rhizome in the global market has provided a market basis for
the development of a Polygonati rhizome International Standard.
However, the quality of Polygonati rhizome provided from different areas or by different cultivators varies
a lot. Although Polygonati rhizome has been recorded in Chinese Pharmacopoeia, Japanese Pharmacopoeia,
Korean pharmacopoeia and Hong Kong Chinese Medicinal Material Standards, these standards are not
harmonized and can be unsuitable for the purpose of international trade of Polygonati rhizome. Thus, there
is a clear and urgent need to develop an International Standard for harmonizing the existing standards, as
well as ensuring the safety and quality of Polygonati rhizome.
As national implementation can differ, national standards bodies can modify the values given in 5.7 in their
national standards. Examples of national and regional values are given in Annex C.
v
FINAL DRAFT International Standard ISO/FDIS 25661:2026(en)
Traditional Chinese medicine — Polygonatum kingianum,
Polygonatum sibiricum, and Polygonatum cyrtonema rhizome
1 Scope
This document specifies the requirements and test methods for Polygonati rhizome, which is derived from
the plant of Polygonatum kingianum Collett & Hemsl., Polygonatum sibiricum Redouté, and Polygonatum
cyrtonema Hua (Fam. Liliaceace).
This document is applicable to Polygonati rhizome that is sold and used as herbal raw materials in the
international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces
derived from this plant.
2 Normative references
The following
...
Style Definition: List Continue 1: Indent: Left: 0 cm,
ISO/DISFDIS 25661
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: 2026-04-2107-01
Traditional Chinese medicine — Polygonatum kingianum,,
Polygonatum sibiricum, and Polygonatum cyrtonema rhizome
DISFDIS stage
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ISO/DISFDIS 25661:2026(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 25661:2026(en)
Contents
Foreword . iii
Introduction . iii
Scope . iii
Normative references . iii
Terms and definitions . iii
Descriptions . iii
Requirements and recommendations . iii
General characteristics . iii
Morphological features . iii
Microscopic characteristics . iii
Thin-layer chromatogram (TLC) identification . iii
Foreign matter . iii
Moisture . iii
Total ash . iii
Extractives . iii
Marker compounds . iii
Heavy metals . iii
Sulfur dioxide . iii
Pesticide residues . iii
Aflatoxins . iii
Sampling . iii
Test methods . iii
Macroscopic identification . iii
Microscopic examination . iii
Thin-layer chromatogram (TLC) identification . iii
Determination of foreign matters . iii
Determination of the moisture content . iii
Determination of the total ash content . iii
Determination of the extractives content . iii
Determination of the solomonseal polysaccharides content . iii
Determination of the heavy metals content . iii
Determination of the sulfur dioxide content . iii
Determination of the pesticide residues content . iii
Determination of the aflatoxins content . iii
Test report . iii
Packaging, storage and transportation . iii
Marking and labelling . iii
(informative) Thin-layer chromatogram (TLC) identification of Polygonati rhizome . iii
(informative) Determination of the solomonseal polysaccharides content . iii
(informative) Reference information of national and regional requirements on Polygonati
rhizome . iii
Bibliography . iii
Foreword . v
Introduction . vi
iii
ISO/DISFDIS 25661:2026(en)
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Descriptions . 2
5 Requirements and recommendations . 5
5.1 General characteristics . 5
5.2 Morphological features . 5
5.3 Microscopic characteristics. 6
5.4 Thin-layer chromatogram (TLC) identification . 8
5.5 Foreign matter . 8
5.6 Moisture . 8
5.7 Total ash . 8
5.8 Extractives . 8
5.9 Marker compounds . 8
5.10 Heavy metals . 8
5.11 Sulfur dioxide . 8
5.12 Pesticide residues . 8
5.13 Aflatoxins . 8
6 Sampling . 8
7 Test methods . 8
7.1 Macroscopic identification . 8
7.2 Microscopic examination . 9
7.3 Thin-layer chromatogram (TLC) identification . 9
7.4 Determination of foreign matters . 9
7.5 Determination of the moisture content . 9
7.6 Determination of the total ash content . 9
7.7 Determination of the extractives content . 9
7.8 Determination of the solomonseal polysaccharides content . 9
7.9 Determination of the heavy metals content . 9
7.10 Determination of the sulfur dioxide content . 9
7.11 Determination of the pesticide residues content . 9
7.12 Determination of the aflatoxins content . 9
8 Test report . 9
9 Packaging, storage and transportation . 10
10 Marking and labelling . 10
Annex A (informative) Thin-layer chromatogram (TLC) identification of Polygonati rhizome . 11
Annex B (informative) Determination of the solomonseal polysaccharides content . 13
Annex C (informative) Reference information of national and regional requirements on
Polygonati rhizome . 14
Bibliography . 16
iv
ISO/DISFDIS 25661:2026(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, 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 25661:2026(en)
Introduction
Polygonati rhizome (Huang Jing) is the dried rhizome of Polygonatum kingianum Collett & Hemsl.,
Polygonatum sibiricum Redouté, and Polygonatum cyrtonema Hua (Fam. Liliaceace). It is found in China, Korea,
Japan, Vietnam, Myanmar, Laos, Thailand, Mongolia, and eastern Siberia, Russia. The dried rhizome of
Polygonatum falcatum A. Gray is also used as Polygonati rhizome in Japanese Pharmacopoeia and Korean
Pharmacopoeia.
Polygonati rhizome has been commonly consumed as a health food supplement and in traditional Chinese
medicine (TCM) for thousands of years due to high nutritional and medicinal values. In Mingyi Bielu (220 AD
to 450 AD), a classic medical text from ancient China, Polygonati rhizome was recorded as one of extremely
valuable herbs. According to the traditional Chinese medicine theory, Polygonati rhizome has the functions of
tonifying the Qi and the Yin, strengthening the spleen, moistening the lung and tonifying the kidney. Modern
pharmacological studies have shown that Polygonati rhizome not only has the effects of lowering blood sugar,
lowering blood lipids, anti-oxidation, anti-cancer, anti-inflammation and antibacterial, but also has the
pharmacological effects of anti-fatigue, immune regulation and anti-aging. This is related to the rich chemical
components of Polygonati rhizome, such as polysaccharide, saponins, flavonoids, alkaloids and amino acids.
Along with a growing number of studies on Polygonati rhizome, various beneficial nutrients within Polygonati
rhizome are being proposed, including carbohydrate, dietary fibre, mineral, vitamin, sugar, amino acid, fatty
acid and protein. Thus, Polygonati rhizome is considered as a popular nutritious food and herb worldwide.
Polygonati rhizome as a special medicinal and edible material, has a lot of international attention and demand.
Searching publications on Polygonati rhizome in the PubMed database for the past ten years reveals that more
than 25 countries and regions have carried out relevant research. The global average annual trade volume of
Polygonati rhizome from 2018 to 2022 was about 5 962 t, and the global average annual trade value is about
57,43 million US dollars. The world's main export countries of Polygonati rhizome are concentrated in China,
Myanmar and India. Among them, China and Myanmar account for about 95,1 % of the world's annual exports.
The main import countries and regions of Polygonati rhizome are: Japan, South Korea, Hong Kong, Taiwan,
Vietnam, Malaysia, the United States, Singapore, Thailand, Germany, Ireland, France, New Zealand, Spain,
Canada, Australia, Italy, Indonesia, Sudan, the Netherlands, the Russian Federation, India, the United Kingdom,
etc. According to Chinese customs data, China's export trade volume of Polygonati rhizome was 2 809 t (in
2018), 2 911 t (in 2019), 3 399 t (in 2020), 6 236 t (in 2021) and 7 001 t (in 2022) with an annual average
export trade value of about 45,57 million US dollars. The analysis of international trade data shows that the
growing demand for Polygonati rhizome in the global market has provided a market basis for the development
of a Polygonati rhizome International Standard.
However, the quality of Polygonati rhizome provided from different areas or by different cultivators varies a
lot. Although Polygonati rhizome has been recorded in Chinese Pharmacopoeia, Japanese Pharmacopoeia,
Korean pharmacopoeia and Hong Kong Chinese Medicinal Material Standards, these standards are not
harmonized and can be unsuitable for the purpose of international trade of Polygonati rhizome. Thus, there is
a clear and urgent need to develop an International Standard for harmonizing the existing standards, as well
as ensuring the safety and quality of Polygonati rhizome.
As national implementation can differ, national standards bodies can modify the values given in 5.7 in their
national standards. Examples of national and regional values are given in Annex C.
vi
ISO/DISFDIS 25661:2026(en)
Traditional Chinese medicine — Polygonatum kingianum,
Polygonatum sibiricum, and Polygonatum cyrtonema rhizome
1 Scope
This document specifies the requirements and test methods for Polygonati rhizome, which is derived from the
plant of Polygonatum kingianum Collett & Hemsl., Polygonatum sibiricum Redouté, and Polygonatum
cyrtonema Hua (Fam. Liliaceace).
This document is applicable to
...