ISO 7177:2023

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
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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
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This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
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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
...