Traditional Chinese medicine — Fermented Cordyceps powder

This document specifies a set of requirements and a test method to control the quality of fermented Cordyceps powder, including test items such as identification, assay, water content, residue on ignition, microbial limit and heavy metals. It is applicable to fermented Cordyceps powder which is produced by liquid fermentation with extracted strain of Ophiocordyceps sinensis (Berk.).

Médecine traditionnelle chinoise — Poudre de Cordyceps fermenté

General Information

Status
Published
Publication Date
17-Nov-2022
Current Stage
6060 - International Standard published
Due Date
10-Mar-2023
Completion Date
18-Nov-2022
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ISO 4754:2022 - Traditional Chinese medicine — Fermented Cordyceps powder Released:18. 11. 2022
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INTERNATIONAL ISO
STANDARD 4754
First edition
2022-11
Traditional Chinese medicine —
Fermented Cordyceps powder
Médecine traditionnelle chinoise — Poudre de Cordyceps fermenté
Reference number
ISO 4754:2022(E)
© ISO 2022
---------------------- Page: 1 ----------------------
ISO 4754:2022(E)
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© ISO 2022

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

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© ISO 2022 – All rights reserved
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ISO 4754:2022(E)
Contents Page

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

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

1 S c op e ................................................................................................................................................................................................................................. 1

2 Nor m at i ve r ef er enc e s ..................................................................................................................................................................................... 1

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

4 Recommendations and requirements .......................................................................................................................................... 2

4.1 Characteristics........................................................................................................................................................................................ 2

4.2 T hin-layer chromatography (TLC) identification ................................................................................................... 2

4.3 H igh-performance liquid chromatography (HPLC) identification ........................................................... 2

4.4 A mino acid analyser identification ...................................................................................................................................... 2

4.5 H eavy metals ............................................................................................................................................................................................ 2

4.6 L oss on drying ......................................................................................................................................................................................... 2

4.7 Residue on ignition ............................................................................................................................................................................. 2

4.8 M icrobial limit ......................................................................................................................................................................................... 2

4.9 A flatoxins .................................................................................................................................................................................................... 2

4.10 C ontent of total amino acids ....................................................................................................................................................... 2

4.11 C ontent of mannitol ............................................................................................................................................................................ 2

4.12 C ontent of adenosine ......................................................................................................................................................................... 2

5 Te s t me t ho d ............................................................................................................................................................................................................... 3

5.1 Ch aracteristics........................................................................................................................................................................................ 3

5.2 T LC identification ......... ............................................................. ........................................................................................................... 3

5.3 H PLC identification ............................................................................................................................................................................. 3

5.4 A mino acid analyser identification ...................................................................................................................................... 3

5.5 D etermination of heavy metals ............................................................................................................................................... 3

5.6 D etermination of loss on drying ............................................................................................................................................. 3

5.7 D etermination of residue on ignition ................................................................................................................................. 3

5.8 M icroorganism examination ...................................................................................................................................................... 3

5.9 D etermination of aflatoxin .......................................................................................................................................................... 3

5.10 D etermination of total amino acids ..................................................................................................................................... 3

5.11 D etermination of mannitol .......................................................................................................................................................... 3

5.12 D etermination of adenosine ....................................................................................................................................................... 4

6 Te s t r ep or t .................................................................................................................................................................................................................. 4

Annex A (informative) Test method for identification by thin layer chromatography (TLC) ................5

Annex B (informative) Test method for identification by high-performance liquid

chromatography (HPLC) .............................................................................................................................................................................. 7

Annex C (normative) Test method for deoxyribonucleic acid (DNA) sequencing ............................................10

Annex D (informative) Test method for adenosine by HPLC ...................................................................................................12

Annex E (informative) Reference values of national and regional limits of heavy metals,

microbiological examination and aflatoxins ......................................................................................................................14

Bibliography .............................................................................................................................................................................................................................16

iii
© ISO 2022 – All rights reserved
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ISO 4754:2022(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.

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 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.
© ISO 2022 – All rights reserved
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ISO 4754:2022(E)
Introduction

Cordyceps sinensis, known as “冬虫夏草”, Chinese Pinyin Dong Chong Xia Cao (winter worm, summer

plant), is a rare raw material used in traditional Chinese medicine. Cordyceps sinensis enjoys equal

popularity with ginseng and velvet and ranks first among these three tonic medicines. The use of

Cordyceps sinensis can be traced to AD 863, during the Tang Dynasty, in the Youyang Essays by Duan

Chengshi. In recent years, the efficacy of Cordyceps sinensis has been further confirmed and its extensive

and significant efficacy is acknowledged worldwide.

The bioactivities of Cordyceps sinensis include immunoregulation, anti-bacteria, anti-cancer, anti-

oxidation, anti-aging, blood sugar control and fat reduction. Due to the specific environment required

for the growth of Cordyceps sinensis, the resources of wild Cordyceps sinensis are limited. Increasing

market demand has therefore resulted in high prices. Driven by increased interest, wild Cordyceps

sinensis is facing extinction due to plunder digging, which impacts its natural ecological environment.

The culture of Cordyceps sinensis has become a hot topic of research, with a focus on liquid fermentation

technology. Fermented Cordyceps powder is manufactured with strain extracted from wild Cordyceps

sinensis by low-temperature liquid fermentation, simulating the growth environment of wild Cordyceps

sinensis. Quality control for fermented Cordyceps powder is complicated. There are many functional

active substances in fermented Cordyceps powder, including polysaccharide compounds, alkaloids

(Cordycepin), peptide compounds, sterols, terpenoids and other secondary metabolites. The content of

these substances in fermented Cordyceps sinensis determines to a large extent the quality and efficacy

of fermented Cordyceps powder. Traditional analytical methods vary and depend highly on experience.

It is difficult to determine the quality of fermented Cordyceps powder with existing methods.

A guarantee of the quality of fermented Cordyceps powder is crucial to ensure the quality and safety

of medicines and health products made from fermented Cordyceps powder. Exploring quality control

methods of fermented Cordyceps powder and creating a standard combining traditional Chinese

medicine characteristics and current technology will have profound influence on the industry of

fermented Cordyceps powder.

As national implementation can differ, national standards bodies are invited to modify the values given

in 4.5, 4.8 and 4.9. Reference values of national and regional limits of heavy metals, microbiological

examination and aflatoxins are given in Annex E.
© ISO 2022 – All rights reserved
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INTERNATIONAL STANDARD ISO 4754:2022(E)
Traditional Chinese medicine — Fermented Cordyceps
powder
1 S cope

This document specifies a set of requirements and a test method to control the quality of fermented

Cordyceps powder, including test items such as identification, assay, water content, residue on ignition,

microbial limit and heavy metals.

It is applicable to fermented Cordyceps powder which is produced by liquid fermentation with extracted

strain of Ophiocordyceps sinensis (Berk.).
2 Normat ive 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 1762, Paper, board, pulps and cellulose nanomaterials — Determination of residue (ash content) on

ignition at 525 °C
ISO 6673, Green coffee — Determination of loss in mass at 105 degrees C
ISO 13903:2005, Animal feeding stuffs — Determination of amino acids content

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

Traditional Chinese Medicine

ISO 22283, Traditional Chinese medicine — Determination of aflatoxins in natural products by LC-FLD

ISO 22467, Traditional Chinese medicine — Determination of microorganisms in natural products

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

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

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
Ophiocordyceps sinensis (Berk.)
sac fungi parasite in bat moth larvae
3.2
fermented Cordyceps powder

dried powder of mycelium obtained by liquid fermentation of Ophiocordyceps sinensis (Berk.)

© ISO 2022 – All rights reserved
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ISO 4754:2022(E)
4 R ecommendations and requirements
4.1 Characteristics
The powder should be grey to greyish yellow, slightly fishy and salty.
4.2 Thin-layer chromat
...

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