ISO 25661

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)
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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

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ISO/DISFDIS 25661:2026(en)
Foreword
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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.
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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.
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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
...