Traditional Chinese medicine -- Glehnia littoralis root

This document specifies the quality and safety requirements of Glehnia littoralis root, which is derived from the plant Glehnia littoralis Fr Schmidt ex Miq. This document applies to Glehnia littoralis root that is sold and used as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.

Médecine traditionnelle chinoise -- racine de Glehnia littoralis

General Information

Status
Published
Publication Date
22-Aug-2021
Current Stage
5060 - Close of voting Proof returned by Secretariat
Start Date
06-Jul-2021
Completion Date
05-Jul-2021
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INTERNATIONAL ISO
STANDARD 23959
First edition
2021-08
Traditional Chinese medicine —
Glehnia littoralis root
Médecine traditionnelle chinoise — racine de Glehnia littoralis
Reference number
ISO 23959:2021(E)
ISO 2021
---------------------- Page: 1 ----------------------
ISO 23959:2021(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
ii © ISO 2021 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 23959:2021(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 General characteristics ..................................................................................................................................................................... 3

5.2 Macroscopic characteristics ........................................................................................................................................................ 4

5.3 Microscopic characteristics .......................................................................................................................................................... 4

5.3.1 Transverse section characteristics ................................................................................................................... 4

5.3.2 Powder characteristics ............................................................................................................................................... 4

5.4 Moisture ........................................................................................................................................................................................................ 4

5.5 Total ash ........................................................................................................................................................................................................ 4

5.6 Acid-insoluble ash ................................................................................................................................................................................ 5

5.7 Thin-layer chromatogram identification .......................................................................................................................... 5

5.8 Marker compounds ............................................................................................................................................................................. 5

5.9 Heavy metals ............................................................................................................................................................................................. 5

5.10 Pesticide residues ................................................................................................................................................................................. 5

5.11 Sulfur dioxide residue ....................................................................................................................................................................... 5

6 Sampling ........................................................................................................................................................................................................................ 5

7 Test methods ............................................................................................................................................................................................................. 6

7.1 Macroscopic identification ........................................................................................................................................................... 6

7.2 Microscopic identification ............................................................................................................................................................. 6

7.2.1 Transverse section examination ......................................................................................................................... 6

7.2.2 Powder examination ..................................................................................................................................................... 6

7.3 Determination of moisture ........................................................................................................................................................... 6

7.4 Determination of total ash ............................................................................................................................................................ 6

7.5 Determination of acid-insoluble ash .................................................................................................................................... 6

7.6 TLC identification ................................................................................................................................................................................. 6

7.7 Determination of marker compounds ................................................................................................................................ 6

7.8 Determination of heavy metals ................................................................................................................................................. 6

7.9 Determination of pesticide residues .................................................................................................................................... 6

7.10 Determination of sulfur dioxide residue .......................................................................................................................... 7

8 Test report ................................................................................................................................................................................................................... 7

9 Packaging, storage and transportation ......................................................................................................................................... 7

10 Marking and labelling ..................................................................................................................................................................................... 7

Annex A (informative) Microscopic identification ................................................................................................................................. 8

Annex B (informative) TLC identification ........................................................................................................................................................ 9

Annex C (informative) Determination of falcarinol ...........................................................................................................................11

Annex D (informative) Referenced values of national and regional limits of moisture, total

ash, acid-insoluble ash, falcarinol and heavy metals in Glehnia littoralis root ................................13

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

© ISO 2021 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO 23959:2021(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.
iv © ISO 2021 – All rights reserved
---------------------- Page: 4 ----------------------
ISO 23959:2021(E)
Introduction

Glehnia littoralis root is the dried or dried peeled root of Glehnia littoralis Fr. Schmidt ex Miq. (Apiaceae),

which is recorded in the Chinese, Japanese and Korean pharmacopoeias, Hong Kong Chinese Materia

Medica Standards and Taiwan herbal pharmacopoeia. Glehnia littoralis root is internationally recognized

as a medicinal material and there is great demand for it in the international market. However, there

are many problems seriously affecting the international trade of Glehnia littoralis root, including the

following:

1) Quality requirements for Glehnia littoralis root are different among different countries and regions.

2) Glehnia littoralis root is often substituted with fake and inferior Glehnia littoralis root.

3) Different collecting times, processing methods, packaging, transportation and storage conditions

often result in different qualities of Glehnia littoralis root.

Therefore, the establishment of an International Standard for Glehnia littoralis root is necessary

to guarantee the quality, safety and consistency of this valuable herbal medicine. This document

includes sections on morphology evaluation (general, macroscopic and microscopic characteristics),

physicochemical indexes (moisture, total ash, acid-insoluble ash, maker compounds, pesticide residues

and sulfur dioxide residue) and heavy metal (lead, arsenic, cadmium and mercury) content.

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

given in 5.4, 5.5, and 5.6 in their national standards. Examples of national and regional values are given

in Annex D.
© ISO 2021 – All rights reserved v
---------------------- Page: 5 ----------------------
INTERNATIONAL STANDARD ISO 23959:2021(E)
Traditional Chinese medicine — Glehnia littoralis root
1 Scope

This document specifies the quality and safety requirements of Glehnia littoralis root, which is derived

from the plant Glehnia littoralis Fr Schmidt ex Miq.

This document applies to Glehnia littoralis root that is sold and used as natural medicine in international

trade, including 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 1666, Starch — Determination of moisture content — Oven-drying method

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 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

World Health Organization, Quality control methods for herbal materials, 2011
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
tap root

main root of Glehnia littoralis Fr. Schmidt ex Miq. that grows straight downwards and produces smaller

side roots
Note 1 to entry: See Figure 1, B.
© ISO 2021 – All rights reserved 1
---------------------- Page: 6 ----------------------
ISO 23959:2021(E)
3.2
stem scar
scar left on the tap root when the stem is removed
Note 1 to entry: See Figure 1, B.
3.3
root length
longest distance from the bottom to the stem scar of the tap root
Note 1 to entry: See Figure 1, B.
Note 2 to entry: Length is measured in centimetres.
3.4
batch
samples collected from the same particular place at the same time
[SOURCE: ISO 21317:2019, 3.5]
4 Descriptions

Glehnia littoralis root is the dried or dried peeled root of Glehnia littoralis Fr. Schmidt ex Miq. (Apiaceae),

and the colour of its outer surface is pale yellowish-white to yellowish-brown (see Figure 1).

2 © ISO 2021 – All rights reserved
---------------------- Page: 7 ----------------------
ISO 23959:2021(E)
Key
A plant of Glehnia littoralis Fr. Schmidt ex Miq. 5 lateral root
B whole root of Glehnia littoralis Fr. Schmidt ex Miq. 6 tap root length
C transverse section of the tap root 7 stem scar
1 inflorescence 8 epidermis
2 leaf 9 phloem
3 leaf sheath 10 xylem
4 tap root 11 cambium
Figure 1 — Structure of Glehnia littoralis
5 Requirements
5.1 General characteristics
The following requirements shall be met before sampling.
a) Glehnia littoralis root shall be clean and free from foreign matter.

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

naked eye shall not be permitted.
© ISO 2021 – All rights reserved 3
---------------------- Page: 8 ----------------------
ISO 23959:2021(E)
5.2 Macroscopic characteristics

a) The root is slender-cylindrical. The top section of the root is slender, the greater portion of the

middle section of the root is thick and the end section of the root becomes slender again towards

the distal end (see Figure 1, A and B).

b) The top section of the root is often marked with remnants of yellowish-brown rhizome base.

c) The root is 9 cm to 45 cm long, 0,2 cm
...

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 23959
ISO/TC 249
Traditional Chinese Medicine —
Secretariat: SAC
Glehnia littoralis root
Voting begins on:
2021­05­10
Voting terminates on:
2021­07­05
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 23959:2021(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 23959:2021(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
CH­1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/FDIS 23959:2021(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 General characteristics ..................................................................................................................................................................... 3

5.2 Macroscopic characteristics ........................................................................................................................................................ 4

5.3 Microscopic characteristics .......................................................................................................................................................... 4

5.3.1 Transverse section characteristics ................................................................................................................... 4

5.3.2 Powder characteristics ............................................................................................................................................... 4

5.4 Moisture ........................................................................................................................................................................................................ 4

5.5 Total ash ........................................................................................................................................................................................................ 4

5.6 Acid­insoluble ash ................................................................................................................................................................................ 5

5.7 Thin-layer chromatogram identification .......................................................................................................................... 5

5.8 Marker compounds ............................................................................................................................................................................. 5

5.9 Heavy metals ............................................................................................................................................................................................. 5

5.10 Pesticide residues ................................................................................................................................................................................. 5

5.11 Sulfur dioxide residue ....................................................................................................................................................................... 5

6 Sampling ........................................................................................................................................................................................................................ 5

7 Test methods ............................................................................................................................................................................................................. 6

7.1 Macroscopic identification ........................................................................................................................................................... 6

7.2 Microscopic identification ............................................................................................................................................................. 6

7.2.1 Transverse section examination ......................................................................................................................... 6

7.2.2 Powder examination ..................................................................................................................................................... 6

7.3 Determination of moisture ........................................................................................................................................................... 6

7.4 Determination of total ash ............................................................................................................................................................ 6

7.5 Determination of acid­insoluble ash .................................................................................................................................... 6

7.6 TLC identification ................................................................................................................................................................................. 6

7.7 Determination of marker compounds ................................................................................................................................ 6

7.8 Determination of heavy metals ................................................................................................................................................. 6

7.9 Determination of pesticide residues .................................................................................................................................... 6

7.10 Determination of sulfur dioxide residue .......................................................................................................................... 7

8 Test report ................................................................................................................................................................................................................... 7

9 Packaging, storage and transportation ......................................................................................................................................... 7

10 Marking and labelling ..................................................................................................................................................................................... 7

Annex A (informative) Microscopic identification ................................................................................................................................. 8

Annex B (informative) TLC identification ........................................................................................................................................................ 9

Annex C (informative) Determination of falcarinol ...........................................................................................................................11

Annex D (informative) Referenced values of national and regional limits of moisture, total

ash, acid-insoluble ash, falcarinol and heavy metals in Glehnia littoralis root ................................13

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

© ISO 2021 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO/FDIS 23959:2021(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 non­governmental, 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.
iv © ISO 2021 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/FDIS 23959:2021(E)
Introduction

Glehnia littoralis root is the dried or dried peeled root of Glehnia littoralis Fr. Schmidt ex Miq. (Apiaceae),

which is recorded in the Chinese, Japanese and Korean pharmacopoeias, Hong Kong Chinese Materia

Medica Standards and Taiwan herbal pharmacopoeia. Glehnia littoralis root is internationally recognized

as a medicinal material and there is great demand for it in the international market. However, there

are many problems seriously affecting the international trade of Glehnia littoralis root, including the

following:

1) Quality requirements for Glehnia littoralis root are different among different countries and regions.

2) Glehnia littoralis root is often substituted with fake and inferior Glehnia littoralis root.

3) Different collecting times, processing methods, packaging, transportation and storage conditions

often result in different qualities of Glehnia littoralis root.

Therefore, the establishment of an International Standard for Glehnia littoralis root is necessary

to guarantee the quality, safety and consistency of this valuable herbal medicine. This document

includes sections on morphology evaluation (general, macroscopic and microscopic characteristics),

physicochemical indexes (moisture, total ash, acid-insoluble ash, maker compounds, pesticide residues

and sulfur dioxide residue) and heavy metal (lead, arsenic, cadmium and mercury) content.

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

given in 5.4, 5.5, and 5.6 in their national standards. Examples of national and regional values are given

in Annex D.
© ISO 2021 – All rights reserved v
---------------------- Page: 5 ----------------------
FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 23959:2021(E)
Traditional Chinese Medicine — Glehnia littoralis root
1 Scope

This document specifies the quality and safety requirements of Glehnia littoralis root, which is derived

from the plant Glehnia littoralis Fr Schmidt ex Miq.

This document applies to Glehnia littoralis root that is sold and used as natural medicine in international

trade, including 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 1666, Starch — Determination of moisture content — Oven-drying method

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 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

World Health Organization, Quality control methods for herbal materials, 2011
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
tap root

main root of Glehnia littoralis Fr. Schmidt ex Miq. that grows straight downwards and produces smaller

side roots
Note 1 to entry: See Figure 1 B.
© ISO 2021 – All rights reserved 1
---------------------- Page: 6 ----------------------
ISO/FDIS 23959:2021(E)
3.2
stem scar
scar left on the tap root when the stem is removed
Note 1 to entry: See Figure 1 B.
3.3
root length
longest distance from the bottom to the stem scar of the tap root
Note 1 to entry: See Figure 1 B.
Note 2 to entry: Length is measured in centimetres.
3.4
batch
samples collected from the same particular place at the same time
[SOURCE: ISO 21317:2019, 3.5]
4 Descriptions

Glehnia littoralis root is the dried or dried peeled root of Glehnia littoralis Fr. Schmidt ex Miq. (Apiaceae),

and the colour of its outer surface is pale yellowish-white to yellowish-brown (see Figure 1).

2 © ISO 2021 – All rights reserved
---------------------- Page: 7 ----------------------
ISO/FDIS 23959:2021(E)
Key
A plant of Glehnia littoralis Fr. Schmidt ex Miq. 5 lateral root
B whole root of Glehnia littoralis Fr. Schmidt ex Miq. 6 tap root length
C transverse section of the tap root 7 stem scar
1 inflorescence 8 epidermis
2 leaf 9 phloem
3 leaf sheath 10 xylem
4 tap root 11 cambium
Figure 1 — Structure of Glehnia littoralis
5 Requirements
5.1 General characteristics
The following requirements shall be met before sampling:
a) Glehnia littoralis root shall be clean and free from foreign matter.

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

naked eye shall not be permitted.
© ISO 2021 – All rights reserved 3
---------------------- Page: 8 ----------------------
ISO/FDIS 23959:2021(E)
5.2 Macroscopic characteristics

a) The root is slender-cylindrical. The top section of the root is slender, the greater portion of the

middle sect
...

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