ISO 22585:2022

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 22585
ISO/TC 249
Traditional Chinese medicine —
Secretariat: SAC
Codonopsis pilosula root
Voting begins on:
2021-12-14
Voting terminates on:
2022-02-08
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Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 22585:2021(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
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NATIONAL REGULATIONS. © ISO 2021

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ISO/FDIS 22585:2021(E)
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© ISO 2021
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ISO/FDIS 22585:2021(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 Morphological features . 3
5.1.1 Appearance . 3
5.1.2 Colour . 3
5.1.3 Dimensions . 3
5.1.4 Texture . 3
5.1.5 Odour and taste . 3
5.2 Moisture . 3
5.3 Total ash . 3
5.4 Acid-insoluble ash . 3
5.5 Ethanol-soluble extractives . 3
5.6 Thin-layer chromatogram (TLC) identification . 3
5.7 Contents of marker compound . 3
5.8 Heavy metals . 4
5.9 Pesticide residues . 4
5.10 Sulfur dioxide residues . . . 4
6 Sampling . 4
7 Test methods . 4
7.1 Macroscopic identification . 4
7.2 Determination of moisture content . 4
7.3 Determination of total ash content . 4
7.4 Determination of acid-insoluble ash content . 4
7.5 Determination of ethanol-solution extractives content . 4
7.6 Thin-layer chromatogram (TLC) identification . 4
7.7 Determination of lobetyolin content . 4
7.8 Determination of heavy metals content . 4
7.9 Determination of pesticide residues content . 4
7.10 Determination of sulfur dioxide residues content . 5
8 Test report . 5
9 Packaging, storage and transportation . 5
10 Marking and labelling . 5
Annex A (informative) Determination of ethanol-soluble extractives . 6
Annex B (informative) Thin-layer chromatogram (TLC) identification . 7
Annex C (informative) Determination of lobetyolin content . 9
Annex D (informative) Referenced values of Codonopsis pilosula root in different countries
and regions.12
Bibliography .14
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ISO/FDIS 22585:2021(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
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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
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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.
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ISO/FDIS 22585:2021(E)
Introduction
Codonopsis pilosula root is dried root of Codonopsis pilosula (Franch.) Nannf. (Family: Campanulaceae). It
has a long history of use in East Asian countries for invigorating the stomach and spleen and benefitting
qi.
Clinically, Codonopsis pilosula root is effective for the treatment of anaemia and malnutrition. To date,
Codonopsis pilosula root occupies a huge share of the international market. However, many problems
affect the quality of Codonopsis pilosula root, such as limited wild resources, increasing demand, the high
investment cost of planting, different quality requirements among different countries and regions, and
different packaging, transportation and storage conditions. Therefore, standardization of Codonopsis
pilosula root is required.
As national implementation can differ, national standards bodies are invited to modify the values given
in 5.2, 5.3, 5.4, 5.5 and 5.7 in their national standards. Examples of national and regional values are
given in Annex D.
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FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 22585:2021(E)
Traditional Chinese medicine — Codonopsis pilosula root
1 Scope
This document specifies the minimum requirements and test methods for Codonopsis pilosula root
derived from the plant of Codonopsis pilosula (Franch.) Nannf.
It is applicable to Codonopsis pilosula root that is sold as 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 18664, Traditional Chinese Medicine — Determination of heavy metals in herbal medicines used in
Traditional Chinese Medicine
ISO 20409, Traditional Chinese medicine — Panax notoginseng root and rhizome
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
ISO 23723:2021, Traditional Chinese medicine — General requirements for herbal raw material and
materia medica
3 Terms and definitions
No terms and definitions are listed in this document.
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
Codonopsis pilosula root
dried root of Codonopsis pilosula (Franch.) Nannf. in the family of Campanulaceaea
1
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ISO/FDIS 22585:2021(E)
3.2
marker compound
chemical constituent within a medicinal herb that can be used to ver
...