Traditional Chinese medicine — Codonopsis pilosula root

This document specifies the minimum requirements and test methods for Codonopsis pilosula root derived from the plant of Codonopsis pilosula (Franch.) Nannf. It is applicable to Codonopsis pilosula root that is sold as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.

Médecine traditionnelle chinoise — Racine de Codonopsis pilosula

General Information

Status
Published
Publication Date
29-Mar-2022
Current Stage
5020 - FDIS ballot initiated: 2 months. Proof sent to secretariat
Start Date
14-Dec-2021
Completion Date
14-Dec-2021
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INTERNATIONAL ISO
STANDARD 22585
First edition
2022-03
Traditional Chinese medicine —
Codonopsis pilosula root
Médecine traditionnelle chinoise — Racine de Codonopsis pilosula
Reference number
ISO 22585:2022(E)
© ISO 2022
---------------------- Page: 1 ----------------------
ISO 22585:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022

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

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on

the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below

or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
© ISO 2022 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 22585:2022(E)
Contents Page

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

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

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

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

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

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

5 Requirements .......................................................................................................................................................................................................... 3

5.1 Morphological features ................................................................................................................................................................... 3

5.1.1 Appearance ............................................................................................................................................................................. 3

5.1.2 Colour ........................................................................................................................................................................................... 3

5.1.3 Dimensions .............................................................................................................................................................................. 3

5.1.4 Texture ........................................................................................................................................................................................ 3

5.1.5 Odour and taste ................................................................................................................................................................... 3

5.2 Moisture ....................................................................................................................................................................................................... 3

5.3 Total ash ....................................................................................................................................................................................................... 3

5.4 Acid-insoluble ash ................................................................................................................................................................................ 3

5.5 Ethanol-soluble extractives ........................................................................................................................................................ 3

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

5.7 Contents of marker compound ................................................................................................................................................. 3

5.8 Heavy metals ............................................................................................................................................................................................ 4

5.9 Pesticide residues ................................................................................................................................................................................ 4

5.10 Sulfur dioxide residues ......... .................................................................................................................................. ......................... 4

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

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

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

7.2 Determination of moisture content ..................................................................................................................................... 4

7.3 Determination of total ash content ...................................................................................................................................... 4

7.4 Determination of acid-insoluble ash content ............................................................................................................... 4

7.5 Determination of ethanol-solution extractives content .................................................................................... 4

7.6 Thin-layer chromatogram (TLC) identification ........................................................................................................ 4

7.7 Determination of lobetyolin content ................................................................................................................................... 4

7.8 Determination of heavy metals content .......................................................................................................................... 4

7.9 Determination of pesticide residues content .............................................................................................................. 4

7.10 Determination of sulfur dioxide residues content .................................................................................................. 5

8 Test report .................................................................................................................................................................................................................. 5

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

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

Annex A (informative) Determination of ethanol-soluble extractives ........................................................................... 6

Annex B (informative) Thin-layer chromatogram (TLC) identification ........................................................................ 7

Annex C (informative) Determination of lobetyolin content ..................................................................................................... 9

Annex D (informative) Referenced values of Codonopsis pilosula root in different countries

and regions..............................................................................................................................................................................................................12

Bibliography .............................................................................................................................................................................................................................14

iii
© ISO 2022 – All rights reserved
---------------------- Page: 3 ----------------------
ISO 22585:2022(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
---------------------- Page: 4 ----------------------
ISO 22585:2022(E)
Introduction

Codonopsis pilosula root is dried root of Codonopsis pilosula (Franch.) Nannf. (Family: Campanulaceae). It

has a long history of use in East Asian countries for invigorating the stomach and spleen and benefitting

qi.

Clinically, Codonopsis pilosula root is effective for the treatment of anaemia and malnutrition. To date,

Codonopsis pilosula root occupies a huge share of the international market. However, many problems

affect the quality of Codonopsis pilosula root, such as limited wild resources, increasing demand, the high

investment cost of planting, different quality requirements among different countries and regions, and

different packaging, transportation and storage conditions. Therefore, standardization of Codonopsis

pilosula root is required.

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

in 5.2, 5.3, 5.4, 5.5 and 5.7 in their national standards. Examples of national and regional values are

given in Annex D.
© ISO 2022 – All rights reserved
---------------------- Page: 5 ----------------------
INTERNATIONAL STANDARD ISO 22585:2022(E)
Traditional Chinese medicine — Codonopsis pilosula root
1 Scope

This document specifies the minimum requirements and test methods for Codonopsis pilosula root

derived from the plant of Codonopsis pilosula (Franch.) Nannf.

It is applicable to Codonopsis pilosula root that is sold as Chinese materia medica (whole medicinal

materials) and decoction pieces derived from this plant.
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 1577, Tea — Determination of acid-insoluble 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

ISO 22217, Traditional Chinese medicine —Storage requirements for raw materials and decoction pieces

ISO 22258, Traditional Chinese medicine — Determination of pesticide residues in natural products by gas

chromatography

ISO 22590, Traditional Chinese medicine — Determination of sulfur dioxide in natural products by titration

ISO 23723:2021, Traditional Chinese medicine — General requirements for herbal raw material and

materia medica
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
Codonopsis pilosula root

dried root of Codonopsis pilosula (Franch.) Nannf. in the family of Campanulaceaea

© ISO 2022 – All rights reserved
---------------------- Page: 6 ----------------------
ISO 22585:2022(E)
3.2
marker compound

chemical constituent within a medicinal herb that can be used to verify its quality

Note 1 to entry: Usually described as active ingredients or chemicals that confirm the correct botanical identity

of the starting material.
Note 2 to entry: There may be one or more marker compounds for a medicinal herb.
4 Descriptions
Codono
...

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 22585
ISO/TC 249
Traditional Chinese medicine —
Secretariat: SAC
Codonopsis pilosula root
Voting begins on:
2021-12-14
Voting terminates on:
2022-02-08
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 22585:2021(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. © ISO 2021
---------------------- Page: 1 ----------------------
ISO/FDIS 22585:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

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

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on

the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below

or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
© ISO 2021 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/FDIS 22585:2021(E)
Contents Page

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

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

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

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

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

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

5 Requirements .......................................................................................................................................................................................................... 3

5.1 Morphological features ................................................................................................................................................................... 3

5.1.1 Appearance ............................................................................................................................................................................. 3

5.1.2 Colour ........................................................................................................................................................................................... 3

5.1.3 Dimensions .............................................................................................................................................................................. 3

5.1.4 Texture ........................................................................................................................................................................................ 3

5.1.5 Odour and taste ................................................................................................................................................................... 3

5.2 Moisture ....................................................................................................................................................................................................... 3

5.3 Total ash ....................................................................................................................................................................................................... 3

5.4 Acid-insoluble ash ................................................................................................................................................................................ 3

5.5 Ethanol-soluble extractives ........................................................................................................................................................ 3

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

5.7 Contents of marker compound ................................................................................................................................................. 3

5.8 Heavy metals ............................................................................................................................................................................................ 4

5.9 Pesticide residues ................................................................................................................................................................................ 4

5.10 Sulfur dioxide residues ......... .................................................................................................................................. ......................... 4

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

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

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

7.2 Determination of moisture content ..................................................................................................................................... 4

7.3 Determination of total ash content ...................................................................................................................................... 4

7.4 Determination of acid-insoluble ash content ............................................................................................................... 4

7.5 Determination of ethanol-solution extractives content .................................................................................... 4

7.6 Thin-layer chromatogram (TLC) identification ........................................................................................................ 4

7.7 Determination of lobetyolin content ................................................................................................................................... 4

7.8 Determination of heavy metals content .......................................................................................................................... 4

7.9 Determination of pesticide residues content .............................................................................................................. 4

7.10 Determination of sulfur dioxide residues content .................................................................................................. 5

8 Test report .................................................................................................................................................................................................................. 5

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

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

Annex A (informative) Determination of ethanol-soluble extractives ........................................................................... 6

Annex B (informative) Thin-layer chromatogram (TLC) identification ........................................................................ 7

Annex C (informative) Determination of lobetyolin content ..................................................................................................... 9

Annex D (informative) Referenced values of Codonopsis pilosula root in different countries

and regions..............................................................................................................................................................................................................12

Bibliography .............................................................................................................................................................................................................................14

iii
© ISO 2021 – All rights reserved
---------------------- Page: 3 ----------------------
ISO/FDIS 22585:2021(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 2021 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/FDIS 22585:2021(E)
Introduction

Codonopsis pilosula root is dried root of Codonopsis pilosula (Franch.) Nannf. (Family: Campanulaceae). It

has a long history of use in East Asian countries for invigorating the stomach and spleen and benefitting

qi.

Clinically, Codonopsis pilosula root is effective for the treatment of anaemia and malnutrition. To date,

Codonopsis pilosula root occupies a huge share of the international market. However, many problems

affect the quality of Codonopsis pilosula root, such as limited wild resources, increasing demand, the high

investment cost of planting, different quality requirements among different countries and regions, and

different packaging, transportation and storage conditions. Therefore, standardization of Codonopsis

pilosula root is required.

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

in 5.2, 5.3, 5.4, 5.5 and 5.7 in their national standards. Examples of national and regional values are

given in Annex D.
© ISO 2021 – All rights reserved
---------------------- Page: 5 ----------------------
FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 22585:2021(E)
Traditional Chinese medicine — Codonopsis pilosula root
1 Scope

This document specifies the minimum requirements and test methods for Codonopsis pilosula root

derived from the plant of Codonopsis pilosula (Franch.) Nannf.

It is applicable to Codonopsis pilosula root that is sold as Chinese materia medica (whole medicinal

materials) and decoction pieces derived from this plant.
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 1577, Tea — Determination of acid-insoluble 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

ISO 22217, Traditional Chinese medicine —Storage requirements for raw materials and decoction pieces

ISO 22258, Traditional Chinese medicine — Determination of pesticide residues in natural products by gas

chromatography

ISO 22590, Traditional Chinese medicine — Determination of sulfur dioxide in natural products by titration

ISO 23723:2021, Traditional Chinese medicine — General requirements for herbal raw material and

materia medica
3 Terms and definitions
No terms and definitions are listed in this document.

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
Codonopsis pilosula root

dried root of Codonopsis pilosula (Franch.) Nannf. in the family of Campanulaceaea

© ISO 2021 – All rights reserved
---------------------- Page: 6 ----------------------
ISO/FDIS 22585:2021(E)
3.2
marker compound
chemical constituent within a medicinal herb that can be used to ver
...

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