ISO 4564:2023

© ISO 4564 – All rights reserved
2022-11-17
ISO/FDIS 4564
ISO/TC 249/ WG 1
Secretariat: SAC
Date: 2023-01-23
Traditional Chinese medicineMedicine — Scutellaria baicalensis
root
Médecine traditionnelle chinoise — Racine de Scutellaria baicalensis
FDIS stage
© ISO 2023 – All rights reserved

---------------------- Page: 1 ----------------------
ISO/FDIS 4564:20222023(E)
© ISO 20XX 2023
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
Fax: +41 22 749 09 47
EmailE-mail: copyright@iso.org
Website: www.iso.orgwww.iso.org
Published in Switzerland
ii © ISO 2022 2023 – All rights reserved

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ISO/FDIS 4564:20222023(E)
Contents
Foreword . v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Descriptions . 1
5 Requirements . 3
5.1 General characteristics . 3
5.2 Morphological features . 3
5.3 Microscopic identification . 3
5.3.1 Transverse section . 3
5.3.2 Powder . 4
5.4 Moisture . 4
5.5 Total ash . 4
5.6 Ethanol-soluble extractives . 4
5.7 Thin-layer chromatogram identification . 4
5.8 Content of marker compounds . 4
5.9 Heavy metals . 4
5.10 Pesticide residues . 4
6 Sampling . 4
7 Test methods . 4
7.1 Macroscopic identification . 4
7.2 Microscopic identification . 4
7.3 Determination of moisture content . 4
7.4 Determination of total ash content . 5
7.5 Determination of ethanol-soluble extractives . 5
7.6 Thin-layer chromatogram identification . 5
7.7 Determination of marker compound . 5
7.8 Determination of heavy metals contents . 5
7.9 Determination of pesticide residues contents . 5
8 Test report . 5
9 Packaging, storage and transportation . 5
10 Marking and labelling . 5
Annex A (informative) Thin-layer chromatogram identification . 7
Annex B (informative) Determination of marker compounds . 9
Annex C (informative) Referenced information of national and regional requirements on Scutellaria
baicalensis root . 12
Bibliography . 14

Foreword iv
Introduction v
© ISO 2022 2023 – All rights reserved iii

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ISO/FDIS 4564:20222023(E)
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 Morphological features 3
5.3 Microscopic identification 3
5.4 Moisture 4
5.5 Total ash 4
5.6 Ethanol-soluble extractives 4
5.7 Thin-layer chromatogram identification 4
5.8 Content of marker compounds 4
5.9 Heavy metals 4
5.10 Pesticide residues 4
6 Sampling 4
7 Test methods 4
7.1 Macroscopic identification 4
7.2 Microscopic identification 4
7.3 Determination of moisture content 4
7.4 Determination of total ash content 4
7.5 Determination of ethanol-soluble extractives 4
7.6 Thin-layer chromatogram identification 5
7.7 Determination of marker compounds 5
7.8 Determination of heavy metals contents 5
7.9 Determination of pesticide residues contents 5
8 Test report 5
9 Packaging, storage and transportation 5
10 Marking and labelling 5
Annex A (informative) Thin-layer chromatogram identification 7
Annex B (informative) Determination of marker compounds 9
Annex C (informative) Referenced information of national and regional requirements on Scutellaria
baicalensis root 11
Bibliography 13

iv © ISO 2022 2023 – All rights reserved

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ISO/FDIS 4564:20222023(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/directiveswww.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/patentswww.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.htmlwww.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.htmlwww.iso.org/members.html.
© ISO 2022 2023 – All rights reserved v

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ISO/FDIS 4564:20222023(E)
Introduction
Scutellaria baicalensis is a traditional herbal medicine with the common name Baikal skullcap or Chinese
skullcap. It is a species of flowering plant of the genus Lamiaceae, widely distributed in China, the Russian
Federation, Mongolia and the Democratic People's Republic of Korea. It is one of the 50 fundamental
herbs used in traditional Chinese medicine and is known as huángqín (黄芩) in Chinese. Its root is the
main medicinal part.
As a traditional Chinese herbal medicine, Scutellaria baicalensis has shown significant effects in the
treatment of various diseases and conditions, including insomnia, anxiety, stroke, fever, high cholesterol,
atherosclerosis, rabies, epilepsy, nervous tension, allergies, skin infections, inflammation and spasms. It
is also used for the treatment of hepatitis, atherosclerosis, hypertension, hyperlipidemia, type 2 diabetes,
dysentery, ulcerative colitis and respiratory disorders.
The purpose of this document is to provide systematic and comprehensive methods for the quality
control of Scutellaria baicalensis for direct medicinal and pharmaceutical use.
As national implementation can differ, national standards bodies are invited to modify the values given
in 5.45.4 and 5.55.5 in their national standards. Examples of national and regional values are given in
Annex C.Annex C.
vi © ISO 2022 2023 – All rights reserved

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ISO/FDIS 4564:2023(E)
Traditional Chinese medicineMedicine — Scutellaria baicalensis
root
1 Scope
This document specifies minimum requirements and test methods for root of Scutellaria baicalensis,
which is derived from cultivated Scutellaria baicalensis Georgi.

This document applies to Scutellaria baicalensis root that are sold and used as natural medicines 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 18664, Traditional Chinese medicineMedicine — Determination of heavy metals in herbal medicines
used in Traditional Chinese medicineMedicine
ISO/TS 21310, Traditional Chinese medicine — Microscopic examination of medicinal herbs
ISO 21371, Traditional Chinese medicine — Labelling requirements of products intended for oral or topical
use
ISO 22217, Traditional Chinese medicine —Storage requirements for raw materials and decoction pieces
ISO 22258, Traditional Chinese medicine — Determination of pesticide residues in natural products by gas
chromatography
ISO 23723, 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/obphttps://www.iso.org/obp
— — IEC Electropedia: available at https://www.electropedia.org/https://www.electropedia.org/
3.1
batch
samples of no more than 5 000 kg collected from the same particular place at the same time
[SOURCE: ISO 23972:2021,3.1]

54 Descriptions
The plant and dried Scutellaria baicalensis root are shown in Figure 1.Figure 1.
© ISO 2023 – All rights reserved 1

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ISO/FDIS 4564:2023(E)
3cm
5cm
2cm

1cm

2 © ISO 2022 2023 – All rights reserved

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ISO/FDIS 4564:2023(E)
Key
A plant of Scutellaria baicalensis C tap root without lateral root
B dried tap root D transverse section of the tap root
1 flowerin
...

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 4564
ISO/TC 249
Traditional Chinese Medicine —
Secretariat: SAC
Scutellaria baicalensis root
Voting begins on:
2023-02-06
Médecine traditionnelle chinoise — Racine de Scutellaria baicalensis
Voting terminates on:
2023-04-03
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 4564:2023(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 2023

---------------------- Page: 1 ----------------------
ISO/FDIS 4564:2023(E)
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 4564
ISO/TC 249
Traditional Chinese Medicine —
Secretariat: SAC
Scutellaria baicalensis root
Voting begins on:
Médecine traditionnelle chinoise — Racine de Scutellaria baicalensis
Voting terminates on:
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
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.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
ISO copyright office
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
CP 401 • Ch. de Blandonnet 8
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
CH-1214 Vernier, Geneva
DOCUMENTATION.
Phone: +41 22 749 01 11
IN ADDITION TO THEIR EVALUATION AS
Reference number
Email: copyright@iso.org
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/FDIS 4564:2023(E)
Website: www.iso.org
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
Published in Switzerland
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN­
DARDS TO WHICH REFERENCE MAY BE MADE IN
ii
  © ISO 2023 – All rights reserved
NATIONAL REGULATIONS. © ISO 2023

---------------------- Page: 2 ----------------------
ISO/FDIS 4564:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Descriptions . 1
5 Requirements . 3
5.1 General characteristics . 3
5.2 Morphological features . 3
5.3 Microscopic identification . 3
5.3.1 Transverse section . . . 3
5.3.2 Powder . 3
5.4 Moisture . 4
5.5 Total ash . 4
5.6 Ethanol-soluble extractives . 4
5.7 Thin-layer chromatogram identification . 4
5.8 Content of marker compounds . 4
5.9 Heavy metals . 4
5.10 Pesticide residues . 4
6 Sampling . 4
7 Test methods . 4
7.1 Macroscopic identification . 4
7.2 Microscopic identification . 4
7.3 Determination of moisture content . 4
7.4 Determination of total ash content . 4
7.5 Determination of ethanol-soluble extractives . 4
7.6 Thin-layer chromatogram identification . 5
7.7 Determination of marker compound . 5
7.8 Determination of heavy metals contents . 5
7.9 Determination of pesticide residues contents. 5
8 Test report . 5
9 Packaging, storage and transportation . 5
10 Marking and labelling . 5
Annex A (informative) Thin-layer chromatogram identification . 7
Annex B (informative) Determination of marker compounds . 9
Annex C (informative) Referenced information of national and regional requirements on
Scutellaria baicalensis root .11
Bibliography .13
iii
© ISO 2023 – All rights reserved

---------------------- Page: 3 ----------------------
ISO/FDIS 4564:2023(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 2023 – All rights reserved

---------------------- Page: 4 ----------------------
ISO/FDIS 4564:2023(E)
Introduction
Scutellaria baicalensis is a traditional herbal medicine with the common name Baikal skullcap or
Chinese skullcap. It is a species of flowering plant of the genus Lamiaceae, widely distributed in China,
the Russian Federation, Mongolia and the Democratic People's Republic of Korea. It is one of the 50
fundamental herbs used in traditional Chinese medicine and is known as huángqín (黄芩) in Chinese.
Its root is the main medicinal part.
As a traditional Chinese herbal medicine, Scutellaria baicalensis has shown significant effects in
the treatment of various diseases and conditions, including insomnia, anxiety, stroke, fever, high
cholesterol, atherosclerosis, rabies, epilepsy, nervous tension, allergies, skin infections, inflammation
and spasms. It is also used for the treatment of hepatitis, atherosclerosis, hypertension, hyperlipidemia,
type 2 diabetes, dysentery, ulcerative colitis and respiratory disorders.
The purpose of this document is to provide systematic and comprehensive methods for the quality
control of Scutellaria baicalensis for direct medicinal and pharmaceutical use.
As national implementation can differ, national standards bodies are invited to modify the values given
in 5.4 and 5.5 in their national standards. Examples of national and regional values are given in Annex C.
v
© ISO 2023 – All rights reserved

---------------------- Page: 5 ----------------------
FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 4564:2023(E)
Traditional Chinese Medicine — Scutellaria baicalensis
root
1 Scope
This document specifies minimum requirements and test methods for root of Scutellaria baicalensis,
which is derived from cultivated Scutellaria baicalensis Georgi.
This document applies to Scutellaria baicalensis root that are sold and used as natural medicines 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 18664, Traditional Chinese Medicine — Determination of heavy metals in herbal medicines used in
Traditional Chinese Medicine
ISO/TS 21310, Traditional Chinese medicine — Microscopic examination of medicinal herbs
ISO 21371, Traditional Chinese medicine — Labelling requirements of products intended for oral or topical
use
ISO 22217, Traditional Chinese medicine —Storage requirements for raw materials and decoction pieces
ISO 22258, Traditional Chinese medicine — Determination of pesticide residues in natural products by gas
chromatography
ISO 23723, 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
...