ISO 9319:2024

International
Standard
ISO 9319
First edition
Traditional Chinese medicine —
2024-02
Poria cocos sclerotium
Médecine traditionnelle chinoise — Poria cocos sclerotium
Reference number
© ISO 2024
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Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Descriptions . 2
5 Quality and safety requirements and recommendations . 2
5.1 General characteristics .2
5.2 Morphological features .3
5.2.1 Whole poria .3
5.2.2 Cubic poria .3
5.2.3 Sliced poria .3
5.3 Microscopic identification .3
5.4 Thin-layer chromatography (TLC) .3
5.5 Chemical colour reaction .3
5.6 Moisture .3
5.7 Total ash .4
5.8 Extractives .4
5.8.1 Ethanol-soluble extractives .4
5.8.2 Water-soluble extractives .4
5.9 Content of marker compound(s) .4
5.10 Heavy metals .4
5.11 Pesticide residues .4
5.12 Sulfur dioxide . .4
6 Sampling . 4
7 Test methods . 4
7.1 Macroscopic identification .4
7.2 Microscopic identification .4
7.3 Thin-layer chromatographic identification .4
7.4 Determination of moisture .4
7.5 Determination of total ash .5
7.6 Determination of extractives .5
7.7 Determination of pachymic acid .5
7.8 Determination of heavy metals .5
7.9 Determination of pesticide residues .5
7.10 Determination of sulfur dioxide .5
8 Test report . 5
9 Packaging, storage and transportation . 5
10 Marking and labelling . 5
Annex A (informative) Thin-layer chromatographic identification . 7
Annex B (informative) Determination of pachymic acid . 9
Annex C (informative) National and regional requirements.12
Bibliography .13

iii
Foreword
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iv
Introduction
Poria cocos sclerotium is the dried sclerotium of the fungus Poria cocos (Schw.) Wolf (Polyporaceae). It is a
medicinal herb which has been widely used as functional food and crude drug to promote urination to drain
dampness, fortify the spleen and calm the heart in Asian countries for thousands of years.
The products of Poria cocos sclerotium are sold all over the world. There are at least 23 countries and
regions using Poria cocos sclerotium and its products. Major users include China, Japan, the Republic of
Korea, Viet Nam, Malaysia and Singapore. Factors including producing areas, processing, packaging and
storage conditions affect the quality of Poria cocos sclerotium. The quality of Poria cocos in the market can
be unstable.
[1]
Poria cocos sclerotium is recorded in the Pharmacopoeia of the People's Republic of China , the European
[5] [2] [4]
Pharmacopoeia , the Japanese Pharmacopoeia and the Korean Pharmacopoeia . However, the
requirements and test methods of Poria cocos in these national and regional standards are varied and can
cause barriers to international trade. In addition, due to its great demand in the global market, trade in
Poria cocos sclerotium can be complicated by adulteration and substitution issues. The establishment of
an International Standard for Poria cocos sclerotium is therefore necessary to ensure quality consistency,
support clinical safety and effectiveness and promote international trade.
As national implementation can differ, national standards bodies are invited to modify the values given in
5.6 and 5.7 in their national standards. Examples of national and regional values are given in Annex C.

v
International Standard ISO 9319:2024(en)
Traditional Chinese medicine — Poria cocos sclerotium
1 Scope
This document specifies the quality, safety requirements and test methods for Poria cocos sclerotium that is
derived from the fungus Poria cocos (Schw.) Wolf.
It is applicable to Poria cocos sclerotium 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 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 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 22258, Traditional Chinese medicine — Det
...