ISO 5106:2025

International
Standard
ISO 5106
First edition
Traditional Chinese medicine —
2025-02
Polygala tenuifolia and Polygala
sibirica root
Médecine traditionnelle chinoise — Racine de Polygala tenuifolia
et Polygala sibirica
Reference number
© ISO 2025
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ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Description . . 2
5 Quality and safety requirements and recommendations . 4
5.1 General characteristics .4
5.2 Macroscopic characteristics .4
5.3 Microscopic characteristics .4
5.3.1 Transverse section . . .4
5.3.2 Powder .4
5.4 Moisture .5
5.5 Total ash .5
5.6 Thin layer chromatogram . .5
5.7 Ethanol-soluble extractives .5
5.8 Content of marker compound(s) .5
5.9 Mycotoxins .5
5.10 Heavy metals .5
5.11 Pesticide residues .5
5.12 Sulfur dioxide residues . .5
6 Sampling . 5
7 Test methods . 5
7.1 Macroscopic identification .5
7.2 Thin-layer chromatographic identification .5
7.3 Determination of moisture .5
7.4 Determination of total ash and acid-insoluble ash .6
7.5 Determination of ethanol-soluble extractives .6
7.6 Determination of marker compound(s).6
7.7 Determination of mycotoxins .6
7.8 Determination of heavy metals .6
7.9 Determination of pesticide residues .6
7.10 Determination of sulfur dioxide residues .6
8 Test report . 6
9 Packaging, storage and transportation . 6
10 Marking and Labelling . 7
Annex A (informative) Thin-layer chromatographic identification . 8
Annex B (informative) Determination of marker compound(s) .10
Annex C (informative) National and regional requirements for Polygala root .13
Bibliography .15

iii
Foreword
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This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
Any feedback or questions on this document should be directed to the user’s national standards body. A
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iv
Introduction
Polygala root is the dried root of Polygala tenuifolia Willd. or Polygala sibirica L. (Polygalaceae). It has the
functions of soothing the nerves, promoting heart and kidney health, removing phlegm, and reducing
swelling. It is used for insomnia, dreaminess, trance, uncomfortable expectoration, sore swelling, breast
swelling and pain. The medicinal materials, decoction pieces and extracts of Polygala root are widely sold
in China, Japan, Republic of Korea, Southeast Asia, North America and other regions. Polygala root has
been included in Chinese Pharmacopoeia, Japanese Pharmacopoeia, Korean Pharmacopoeia and European
Pharmacopoeia, but their requirements and test methods are different. Besides, there are traditional
Chinese medicine (TCM) such as Liriope spicata root on the market, which is usually confused with Polygala
root; and the aflatoxins in Polygala root may exceed the maximum residue limit if stored improperly. In
addition, the grade of medicinal materials is not linked to the intrinsic quality. These problems can affect
the international trade of Polygala root. Therefore, it is necessary to establish an International Standard to
bring benefits to the consumers, enterprises and companies involved in the processing, management and
trade of Polygala tenuifolia and Polygala sibirica root, and ensure its quality and safety.
As national implementation can differ, national standards bodies are invited to modify the values given in
5.5 in their national standards. Examples of national and regional values are given in Annex C.

v
International Standard ISO 5106:2025(en)
Traditional Chinese medicine — Polygala tenuifolia and
Polygala sibirica root
1 Scope
This document specifies the minimum requirements and test methods for Polygala tenuifolia and Polygala
sibirica root.
It applies to Polygala tenuifolia and Polygala sibirica root that are sold and used as natural medicines in
international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces.
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 15378, Primary packaging materials for medicinal products — Particular requirements for the application
of ISO 9001:2015, with reference to good manufacturing practice (GMP)
ISO 18664, Traditional Chinese Medicine — Determination of heavy metals in herbal medicines used in
Traditional Chinese Medicine
ISO 21371, Traditional Chinese medicine — Labelling requirements of products intended for oral or topical use
ISO 22217, Traditional Chinese medicine —Storage requirements for raw materials and decoction pieces
ISO 22283, Traditional Chinese medicine — Determination of aflatoxins in natural prod
...