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

Overview

ISO 7177:2023 - Traditional Chinese medicine - Coptis chinensis and Coptis japonica rhizome specifies minimum requirements and test methods for Coptis rhizome (dried rhizome of Coptis chinensis Franch. and Coptis japonica Makino.). The standard applies to whole Chinese materia medica and decoction pieces, and focuses on identity, purity and safety parameters to support consistent quality, international trade and regulatory compliance for this commonly used TCM herb.

Key topics and technical requirements

• Identification and description
  • Macroscopic and microscopic characteristics for Coptis chinensis and Coptis japonica (shape, size ranges, surface features, colour, odour and taste).
  • Microscopic features (cork layers, cortex, stone cells, vascular bundles) and common adulterant identification.
• Analytical methods
  • Thin-layer chromatography (TLC) identification (Annex A) - required fluorescent spot pattern matching reference.
  • Marker compound determination (Annex B) - quantification of alkaloids such as berberine, epiberberine, coptisine and palmatine (HPLC-UV method described).
• Quality and safety limits
  • Moisture ≤ 14.0% (mass fraction)
  • Total ash ≤ 5.0% (mass fraction)
  • Acid-insoluble ash ≤ 2.5% (mass fraction)
  • Determination of heavy metals (As, Hg, Pb, Cd) and pesticide residues required.
• Sampling and testing
  • Sampling per ISO 23723:2021.
  • Test methods reference ISO/TS 21310 (microscopy), ISO 18664 (heavy metals), ISO 22258 (pesticide residues) and internal test clauses.
• Packaging, storage and labelling
  • Guidance aligns with ISO 22217 (storage) and ISO 21371 (labelling) for decoction pieces and raw material handling.

Applications and who uses it

ISO 7177:2023 is used by:

• Quality control laboratories and analytical chemists validating TLC and HPLC-UV methods for Coptis rhizome.
• Herbal raw material suppliers, growers and processors to meet minimum quality specs for Coptis chinensis and Coptis japonica.
• Manufacturers of decoction pieces and finished TCM products to ensure ingredient compliance and safety (heavy metals, pesticides).
• Regulators, customs authorities and standards bodies harmonizing trade requirements for Traditional Chinese Medicine (TCM) ingredients.
• Researchers and pharmacopoeia committees benchmarking marker compound assays and identity tests.

Practical benefits include improved batch-to-batch consistency, reduced adulteration risk, safer herbal products, and smoother international trade for Coptis rhizome.

Related standards

Normative references cited in ISO 7177:2023 include:

• ISO 23723:2021 (sampling; general requirements)
• ISO/TS 21310 (microscopic examination)
• ISO 18664 (heavy metals)
• ISO 22258 (pesticide residues)
• ISO 21371 (labelling)
• ISO 22217 (storage)

For national implementation details and example values, see Annex C of ISO 7177:2023.

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 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
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Phone: [phone]
Email: [e-mail]
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Published in Switzerland
ii
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
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
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electrotechnical standardization.
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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
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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
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
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
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
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
...