Traditional Chinese medicine -- Ganoderma lucidum fruiting body

This document specifies minimum requirements and test methods for Ganoderma lucidum fruiting body that is derived from Ganoderma lucidum (Leyss. ex Fr.) Karst. It is applicable to Ganoderma lucidum fruiting body that is sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this fungus.

Médecine traditionnelle chinoise -- Organe fructifère de Ganoderma lucidum

General Information

Status
Published
Publication Date
19-Dec-2018
Current Stage
6060 - International Standard published
Start Date
14-Nov-2018
Completion Date
20-Dec-2018
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ISO 21315:2018 - Traditional Chinese medicine -- Ganoderma lucidum fruiting body
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INTERNATIONAL ISO
STANDARD 21315
First edition
2018-12
Traditional Chinese medicine —
Ganoderma lucidum fruiting body
Médecine traditionnelle chinoise — Organe fructifère de
Ganoderma lucidum
Reference number
ISO 21315:2018(E)
ISO 2018
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ISO 21315:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2018

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ii © ISO 2018 – All rights reserved
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ISO 21315:2018(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Descriptions .............................................................................................................................................................................................................. 2

5 Requirements .......................................................................................................................................................................................................... 2

5.1 General characteristics ..................................................................................................................................................................... 2

5.2 Ganoderma lucidum fruiting body ...................................................................................................................................... 3

5.2.1 Morphological features of fruiting body ...................................................................................................... 3

5.2.2 Thin-layer chromatogram (TLC) identification .................. ................................................................... 3

5.2.3 Moisture .................................................................................................................................................................................. 3

5.2.4 Total ash .................................................................................................................................................................................. 3

5.2.5 Water-soluble extractives ........................................................................................................................................ 3

5.2.6 Marker compounds ........................................................................................................................................... ............. 3

5.2.7 Heavy metals ....................................................................................................................................................................... 3

5.2.8 Pesticide residues ........................................................................................................................................................... 3

6 Sampling ........................................................................................................................................................................................................................ 4

7 Test methods ............................................................................................................................................................................................................. 4

7.1 Macroscopic identification ........................................................................................................................................................... 4

7.2 TLC identification ................................................................................................................................................................................. 4

7.3 Determination of moisture content ...................................................................................................................................... 4

7.4 Determination of total ash ............................................................................................................................................................ 4

7.5 Determination of water-soluble extractives .................................................................................................................. 4

7.6 Determination of marker compounds ................................................................................................................................ 4

7.7 Determination of heavy metals ................................................................................................................................................. 4

7.8 Determination of pesticide residues .................................................................................................................................... 4

8 Test report ................................................................................................................................................................................................................... 4

9 Packaging, storage and transportation ......................................................................................................................................... 5

10 Marking and labelling ..................................................................................................................................................................................... 5

Annex A (informative) TLC identification........................................................................................................................................................ 6

Annex B (informative) Determination of water-soluble extractives ................................................................................... 8

Annex C (informative) Determination of polysaccharides ............................................................................................................ 9

Annex D (informative) Determination of ganoderic acid A .......................................................................................................11

Annex E (informative) Reference values of national and regional limits of moisture, total

ash, water-soluble extractives, polysaccharides, ganoderic acid A and heavy metals

in Ganoderma lucidum fruiting body ............................................................................................................................................14

Bibliography .............................................................................................................................................................................................................................15

© ISO 2018 – All rights reserved iii
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ISO 21315:2018(E)
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 documents 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).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

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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 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 2018 – All rights reserved
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ISO 21315:2018(E)
Introduction

Ganoderma lucidum fruiting body is the dried fruiting body of Ganoderma lucidum (Leyss. ex Fr.)

Karst., which is also known as Lingzhi or Reishi. It has been used as a medicinal mushroom in many

Asian countries for more than 2000 years, such as China, Japan and Korea, making it one of the oldest

mushrooms known to have been used medicinally. This fungus can tonify Qi, and is traditionally used

to treat fatigue, cough and insomnia in traditional Chinese medicine. Modern pharmacological studies

also demonstrate its great potential in tumour treatment and immuno-enhancement. Therefore,

the market of Ganoderma lucidum has developed very rapidly, as indicated by the increase in yield,

production output and trade volume.

However, there remain many challenges, such as adulteration of similar species, and lack of suitable

testing methods for quality assessment. In addition, though Ganoderma lucidum has been recorded in

several pharmacopoeias, such as Chinese Pharmacopoeia, United States Pharmacopeia Herbal Medicines

Compendium and the Korean Herbal Pharmacopoeia, the specifications and quality requirements in

these standards vary. Therefore, there is a clear and urgent need to develop an international standard

for harmonizing the existing standards, as well as ensuring the safety and effectiveness of Ganoderma

lucidum fruiting body.

As national implementation may differ, National Standards Bodies are invited to modify the values

given in 5.2.3, 5.2.4 and 5.2.5 in their national standards. Examples of national and regional values are

given in Annex E.
© ISO 2018 – All rights reserved v
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INTERNATIONAL STANDARD ISO 21315:2018(E)
Traditional Chinese medicine — Ganoderma lucidum
fruiting body
1 Scope

This document specifies minimum requirements and test methods for Ganoderma lucidum fruiting

body that is derived from Ganoderma lucidum (Leyss. ex Fr.) Karst.

It is applicable to Ganoderma lucidum fruiting body that is sold and used as Chinese materia medica

(whole medicinal materials) and decoction pieces derived from this fungus.
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 1575, Tea — Determination of total ash

ISO 18664, Traditional Chinese Medicine — Determination of heavy metals in herbal medicines used in

Traditional Chinese Medicine
ISO 20409, Traditional Chinese medicine — Panax notoginseng root and rhizome

ISO 21371, Traditional Chinese medicine — Labelling requirements of products intended for oral or topical use

CAC/MRL01, Maximum Residue Limits for Pesticides in Food
CODEX STAN 229, Analysis of pesticide residues: Recommended methods

World Health Organization. 2011, Quality control methods for herbal materials, General advice on

sampling
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
3.1
fruiting body
dried sporocarp of Ganoderma lucidum (Leyss. ex Fr.) Karst.
3.2
reference standard

authentic substance used as a measurement base for TLC identification or marker compound

quantification
© ISO 2018 – All rights reserved 1
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ISO 21315:2018(E)
4 Descriptions

Ganoderma lucidum fruiting body is the dried fruiting body of Ganoderma lucidum (Leyss. ex Fr.) Karst.

in the family of Ganodermataceae shown in Figure 1.
a) Fruiting body of Ganoderma lucidum b) Vertical section of pileus
Key
1 pileus
2 stipe
3 pileus diameter
4 stipe length
5 spore
6 crust
7 context
8 tube
Figure 1 — Structure of Ganoderma lucidum
5 Requirements
5.1 General characteristics
The following requirements shall be met before sampling.
a) Ganoderma lucidum fruiting body shall be clean and free from foreign matter.
2 © ISO 2018 – All rights reserved
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ISO 21315:2018(E)

b) The presence of living insects, moulds and external contaminants which are visible to the naked

eye shall not be permitted.
5.2 Ganoderma lucidum fruiting body
5.2.1 Morphological features of fruiting body

a) Outline of fruiting body umbrella-shaped, pileus reniform, semi-rounded or surrounded, 10 cm to

30 cm in diameter, 1 cm to 4 cm thick.

b) Colour of pileus varies, yellowish-brown to reddish-brown, lustrous, with circular stripe and

radiate wrinkle.

c) Stipe cylinder, usually 4 cm to 15 cm long, 1 cm to 3,5 cm in diameter, reddish-brown, luminous;

attachment of the stipe to the pileus varies from lateral to nearly central.
d) Spore small and fine, yellowish-brown.
e) Odour slightly aromatic, taste slightly bitter.

f) Crust hard, colour similar to pileus or darker, the context varies in colour from yellowish-brown to

dark brown, the length of tube layer varies from short (less than one-third of the pileus thickness)

to long (more than one-third of the pileus thickness).
5.2.2 Thin-layer chromatogram (TLC) identification

The identification of Ganoderma lucidum fruiting body with thin-layer chromatogram (

...

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