ISO 7177:2023

Traditional Chinese medicine — Coptis chinensis and Coptis japonica rhizome

This document specifies the minimum requirements and test methods for Coptis rhizome (the dried rhizome of Coptis chinensis Franch. and Coptis japonica Makino.). This document applies to Coptis rhizome sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from these plants. This document does not apply to the processed Coptis rhizome, including products traditionally processed with different methods, or its processing methods.

Médecine traditionnelle chinoise — Rhizome de Coptis chinensis et de Coptis japonica

General Information

• Status: Published
• Publication Date: 18-Jul-2023
• ICS: 11.120.10 - Medicaments
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249 - Traditional Chinese medicine
• Current Stage: 6060 - International Standard published
• Start Date: 19-Jul-2023
• Due Date: 15-Sep-2024
• Completion Date: 19-Jul-2023

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 7177
First edition
2023-07
Traditional Chinese medicine — Coptis
chinensis and Coptis japonica rhizome
Médecine traditionnelle chinoise — Rhizome de Coptis chinensis et
de Coptis japonica
Reference number
ISO 7177:2023(E)
© ISO 2023

---------------------- Page: 1 ----------------------
ISO 7177:2023(E)
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.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
  © ISO 2023 – All rights reserved

---------------------- Page: 2 ----------------------
ISO 7177:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Description . .2
5 Requirements . 3
5.1 General characteristics . 3
5.2 Morphological features of rhizome . 3
5.3 Microscopic identification . 3
5.4 Thin-layer chromatography (TLC) identification . 4
5.5 Moisture . 4
5.6 Total ash . 4
5.7 Acid-insoluble ash . 4
5.8 Heavy metals . 4
5.9 Pesticide residues . 5
5.10 Marker compounds . 5
6 Sampling . 5
7 Test methods . 5
7.1 Macroscopic identification . 5
7.2 Microscopic identification . 5
7.3 Thin-layer chromatography (TLC) identification . 5
7.4 Determination of moisture . 5
7.5 Determination of total ash . 5
7.6 Determination of acid-insoluble ash . 5
7.7 Determination of heavy metals . 5
7.8 Determination of pesticide residues . 5
7.9 Determination of marker compounds . 5
8 Test report . 6
9 Packaging, storage and transportation . 6
10 Marking and labelling . 6
Annex A (informative) Thin-layer chromatography (TLC) identification of Coptis rhizome .7
Annex B (informative) Determination of marker compounds by high-performance liquid
chromatography with an ultraviolet detector (HPLC-UV) . 9
Annex C (informative) National and regional requirements for Coptis rhizome .12
Bibliography .14
iii
© ISO 2023 – All rights reserved

---------------------- Page: 3 ----------------------
ISO 7177:2023(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 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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use
of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed
patent rights in respect thereof. As of the date of publication of this document, ISO had not received
notice of (a) patent(s) which may be required to implement this document. However, implementers are
cautioned that this may not represent the latest information, which may be obtained from the patent
database available at  www.iso.org/patents. ISO shall not be held responsible for identifying any or all
such patent rights.
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 7177:2023(E)
Introduction
Coptis rhizome is used as traditional Chinese medicine in China. The rhizome of Coptis japonica Makino.
is also used as herbal medicine in Japan and the Republic of Korea. As one of the most commonly used
medicinal herbs, Coptis rhizome was listed in Shennong materia Medica. Treatise on Febrile diseases
contains 113 prescriptions, including 12 containing Coptis rhizome.
However, there are still some concerns about the quality control of Coptis rhizome, outlined as follows,
which affect the trade and use of this herb.
a) The harvesting and processing methods and techniques have not been standardized. Issues such as
low efficiency, large interference from human factors and poor controllability seriously affect the
quality of Coptis rhizome materials.
b) Even though many countries or regions, such as China, Japan, the Republic of Korea and Europe,
have established pharmacopoeia standards for Coptis rhizome, the relevant requirements vary
significantly, which limits the application of those standards in global trade.
c) The lack of quality standards for certain processed products, such as Coptis rhizome products
processed with wine, ginger or Euodia fruit, makes it difficult to control their quality. This can
affect the efficacy and safety of these products.
Coptis rhizome is ranked the fourth in the priority list of single herbal medicines for developing
standards in ISO/TR 23975:2019. Thus, it is essential to develop an International Standard for Coptis
rhizome to ensure consistency in the quality of Coptis rhizome and safe use of this herb and also to
promote international trade.
In this document, the identification of commonly adulterated species of Coptis rhizome is also
introduced.
As national implementation can differ, national standards bodies are invited to modify the values given
in 5.5, 5.6 and 5.7 based on their national standards. Examples of national values are given in Annex C.
v
© ISO 2023 – All rights reserved

---------------------- Page: 5 ----------------------
INTERNATIONAL STANDARD ISO 7177:2023(E)
Traditional Chinese medicine — Coptis chinensis and Coptis
japonica rhizome
1 Scope
This document specifies the minimum requirements and test methods for Coptis rhizome (the dried
rhizome of Coptis chinensis Franch. and Coptis japonica Makino.).
This document applies to Coptis rhizome sold and used as Chinese materia medica (whole medicinal
materials) and decoction pieces derived from these plants.
This document does not apply to the processed Coptis rhizome, including products traditionally
processed with different methods, or its processing methods.
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 22217:2020, 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 23723:2021, 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
Coptis rhizome
dried rhizome of Coptis chinensis Franch. and Coptis japonica Makino.
3.2
bridge piece
morphological feature of Coptis rhizome with its rhizome internodes as smooth as stem
1
© ISO 2023 – All rights reserved

---------------------- Page: 6 ----------------------
ISO 7177:2023(E)
4 Description
Coptis rhizome is the dried rhizome of Coptis chinensis Franch. and Coptis japonica Makino., collected in
autumn, removed from rootlets and soil and dried, as shown in Figure 1.
a) Plant of Coptis chinensis Franch. b) Plant of Coptis japonica Makino.
c) Coptis chinensis rhizome d) Coptis japonica rhizome
Key
1 leaf
2 petiolate
3 phyllode
4 bridge piece
5 rhizome
6 fibrous root
7 flower
8 nodular bump
Figure 1 — Structure of Coptis rhizome
2
  © ISO 2023 – All rights reserved

---------------------- Page: 7 ----------------------
ISO 7177:2023(E)
5 Requirements
5.1 General characteristics
The following requirements shall be met before sampling:
a) Coptis rhizome shall be clean and free from leaves and foreign matter.
b) The presence of living insects, mouldy fruit and external contaminants which are visible to the
naked eye shall not be permitted.
5.2 Morphological features of rhizo
...

DRAFT INTERNATIONAL STANDARD
ISO/DIS 7177
ISO/TC 249 Secretariat: SAC
Voting begins on: Voting terminates on:
2022-07-20 2022-10-12
Traditional Chinese Medicine — Coptis chinensis and Coptis
japonica rhizome
ICS: 11.120.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
This document is circulated as received from the committee secretariat.
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 7177:2022(E)
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 SUPPORTING DOCUMENTATION. © ISO 2022

---------------------- Page: 1 ----------------------
ISO/DIS 7177:2022(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 7177
ISO/TC 249 Secretariat: SAC
Voting begins on: Voting terminates on:

Traditional Chinese Medicine — Coptis chinensis and Coptis
japonica rhizome
ICS: 11.120.10
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2022
THEREFORE SUBJECT TO CHANGE AND MAY
This document is circulated as received from the committee secretariat.
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: [phone]
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: [e-mail]
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 7177:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
  © ISO 2022 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022

---------------------- Page: 2 ----------------------
ISO/DIS 7177:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Description . .2
5 Requirements . 2
5.1 General characteristics . 2
5.2 Morphological features of rhizome . 3
5.3 Microscopic identification . 3
5.4 Thin-layer chromatogram (TLC) identification . 4
5.5 Moisture . 4
5.6 Total ash . 4
5.7 Acid-insoluble ash . 4
5.8 Heavy metals . 4
5.9 Pesticide residues . 5
5.10 Marker compounds . 5
6 Sampling . 5
7 Test methods . 5
7.1 Macroscopic identification . 5
7.2 Microscopic identification . 5
7.3 Thin-layer chromatogram (TLC) identification . 5
7.4 Determination of moisture . 5
7.5 Determination of total ash . 5
7.6 Determination of acid-insoluble ash . 5
7.7 Determination of heavy metals . 5
7.8 Determination of pesticide residues . 5
7.9 Determination of marker compounds . 6
8 Test report . 6
9 Packaging, storage, and transportation . 6
10 Marking and labelling . 6
Annex A (informative) Thin-layer chromatogram (TLC) identification . 7
Annex B (informative) Determination of marker compounds by HPLC-UV .9
Annex C (informative) Reference information of national and regional requirements .12
Bibliography .14
iii
© ISO 2022 – All rights reserved

---------------------- Page: 3 ----------------------
ISO/DIS 7177:2022(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.
iv
  © ISO 2022 – All rights reserved

---------------------- Page: 4 ----------------------
ISO/DIS 7177:2022(E)
Introduction
Coptis rhizome is the dried rhizome of Coptis chinensis Franch., Coptis deltoidea C.Y. Cheng et Hsiao, and
Coptis teeta Wall. used in traditional Chinese medicine (TCM) in China. The rhizome of Coptis japonica
Makino. is also used as an herbal medicine in Japan and South Korea. As one of the commonly used
medicinal herb, Coptis rhizome was listed in Shennong materia Medica. Treatise on February-related
diseases contains 113 prescriptions, including 12 containing Coptis rhizome.
In TCM, Coptis rhizome has a cold property and bitter flavour. It belongs to heart, spleen, stomach,
liver, gallbladder, and large intestine meridians. And it is often used to clear heat, dry dampness, purge
fire and remove the toxin. Its main chemical components are alkaloids, including berberine, coptisine,
palmatine and epiberberine. It also contains ferulic acid, chlorogenic acid, quercetin, and other non-
alkaloid components. Modern pharmacological studies have shown that the alkaloids in Coptis
rhizome can resist pathogenic microorganisms and inhibit various diseases and conditions, including
arrhythmia, cancer, diabetes, and inflammation. It can also regulate immune and platelet functions, and
protect the gastric mucosa. The alkaloids of Coptis rhizome have been widely used clinically for treating
digestive, respiratory, and dermatological infectious diseases, and certain cardiovascular conditions,
In the global trade of Coptis rhizome, according to the China Customs data, Coptis rhizome from the
mainland of China is mainly exported to Japan, South Korea, the United States, India, Singapore,
Thailand, Vietnam, Malaysia, Hong Kong, Macao, and Taiwan. From 2012 to 2016, the average annual
export trade of Coptis rhizome amounted to US$ 4,12 million, which was one of the main Chinese herbal
medicines exported from China.
However, there are still some concerns on the quality control of Coptis rhizome as follows, which affects
the trade and use of this herb.
1. The harvesting and processing methods and techniques have not been standardized. The problems,
such as low efficiency, large interference from human factors, and poor controllability, seriously
affect the quality of Coptis rhizome materials.
2. Even though many countries or regions, e.g., China, Japan, Korea, and Europe, have established
Pharmacopoeia standards for Coptis rhizome, the relevant requirements vary significantly, which
limits the application of those standards in the global trade.
3. The lack of quality standards for certain processed products, such as Coptis rhizome products
processed with wine, ginger, or Euodia fruit, makes it difficult to control their quality. This may
affect the efficacy and safety of these products.
Moreover, Coptis rhizome is ranked the fourth in the ISO/TR 23975: 2019 Traditional Chinese
medicine — Priority list of single herbal medicines for developing standards. Thus, it is essential to
develop the international standard for Coptis rhizome to ensure the consistency in the quality of Coptis
rhizome, which is for the safe use of this herb and also promote the international trade.
In this document, the identification of commonly adulterated species of Coptis rhizome is also
introduced.
In addition, as the requirement and implementation may differ in different countries, the users are
invited to modify the values given in 5.5, 5.6, 5.7, and 5.10 according to their national standards.
Examples of national values are given in Annex C.
v
© ISO 2022 – All rights reserved

---------------------- Page: 5 ----------------------
DRAFT INTERNATIONAL STANDARD ISO/DIS 7177:2022(E)
Traditional Chinese Medicine — Coptis chinensis and Coptis
japonica rhizome
1 Scope
This document specifies the minimum requirements and test methods for Coptis rhizome [the dried
rhizome of Coptis chinensis Franch. and Coptis japonica Makino.].
This document applies to Coptis rhizome sold and used as Chinese materia medica (whole medicinal
materials) and decoction pieces derived from these plants.
This document does not apply to the processed Coptis rhizome, including the products traditionally
processed with different methods, and its processing methods.
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 terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: avai
...