ISO 20409:2017

Traditional Chinese medicine — Panax notoginseng root and rhizome

ISO 20409:2017are derived from the plant Panax notoginseng (Burk.) F.H. Chen. It is applicable to notoginseng root and rhizome that are sold and used as food supplements, functional food or natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.

Médecine traditionnelle chinoise — Rhizome et racine de Panax notoginseng

General Information

• Status: Published
• Publication Date: 22-May-2017
• ICS: 11.120.10 - Medicaments
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249 - Traditional Chinese medicine
• Current Stage: 9093 - International Standard confirmed
• Completion Date: 31-Oct-2022

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 20409
First edition
2017-06
Traditional Chinese medicine —
Panax notoginseng root and rhizome
Médecine traditionnelle chinoise — Rhizome et racine de Panax
notoginseng
Reference number
ISO 20409:2017(E)
©
ISO 2017

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ISO 20409:2017(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland
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ISO 20409:2017(E)

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Descriptions . 2
5 Requirements . 4
5.1 General characteristics . 4
5.2 Notoginseng root . 4
5.2.1 Morphological features of root . 4
5.2.2 Moisture . 4
5.2.3 Total ash . 4
5.2.4 Acid-insoluble ash . 4
5.2.5 Ethanol-soluble extractives . 4
5.2.6 Identification of notoginsenoside R and ginsenosides Rg , Re, and Rb .
1 1 1 4
5.2.7 Content of notoginsenoside R and ginsenosides Rg and Rb .
1 1 1 4
5.2.8 Heavy metals . 5
5.2.9 Pesticide residues . 5
5.2.10 Root weight, root length and root number per 500 g . 5
5.3 Notoginseng rhizome . 5
5.3.1 Morphological features of rhizome . 5
5.3.2 Moisture . 5
5.3.3 Total ash . 5
5.3.4 Acid-insoluble ash . 5
5.3.5 Ethanol-soluble extractives . 5
5.3.6 Identification of notoginsenoside R and ginsenosides Rg , Re, and Rb .
1 1 1 6
5.3.7 Content of notoginsenoside R and ginsenosides Rg and Rb .
1 1 1 6
5.3.8 Heavy metals . 6
5.3.9 Pesticide residues . 6
6 Sampling . 6
7 Test methods . 7
7.1 Macroscopic identification . 7
7.2 Determination of moisture content . 7
7.3 Determination of total ash content. 7
7.4 Determination of acid-insoluble ash content . 7
7.5 Determination of ethanol-soluble extractives content . 7
7.6 Identification of notoginsenoside R and ginsenosides Rg , Re, and Rb .
1 1 1 7
7.7 Determination of notoginsenoside and ginsenosides content . 7
7.8 Determination of heavy metals . 7
7.9 Determination of pesticide residues . 7
7.10 Root weight . 7
7.11 Root length . 8
7.12 Root number per 500 g . 8
8 Test report . 8
9 Packaging, storage and transportation . 8
10 Marking and labelling . 8
Annex A (normative) Determination of moisture content . 9
Annex B (normative) Determination of ethanol-soluble extractives content .10
Annex C (normative) Identification of ginsenosides Rb , Re, Rg and notoginsenoside R .11
1 1 1
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ISO 20409:2017(E)

Annex D (normative) Determination of notoginsenoside R and ginsenosides Rg and Rb .13
1 1 1
Annex E (informative) Reference values of national and regional limits of notoginsenoside
R ginsenosides Rg , Re, Rb and Rd in notoginseng.16
1, 1 1
Bibliography .17
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ISO 20409:2017(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
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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
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
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For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
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URL: w w w . i s o .org/ iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
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ISO 20409:2017(E)

Introduction
Panax notoginseng root and rhizome are medicinal parts of Panax notoginseng (Burk.) F.H. Chen named
Sanqi, which is a well-known traditional Chinese medicine. Due to its ability to treat bleeding, blood
stasis and some other blood disorders, Panax notoginseng root and rhizome soared to great importance
th
during Qing dynasty times after being praised by the master herbalist Li Shizhen in the 16 century.
Panax notoginseng root and rhizome are native to the southern Chinese provinces of Yunnan and
Guangxi, as well as Vietnam. The root and rhizome exhibit a variety of botanical and biochemical
similarities to ginseng, and are frequently consumed as soup. Despite this high rate of consumption,
there are relatively few reported side effects, making Panax notoginseng root and rhizome two of the
safest substances in traditional Chinese medicine. While most often consumed as a popular food tonic,
practitioners of Oriental medicine know Panax notoginseng root and rhizome best for the medicinal
qualities: moving stagnant blood, stopping bleeding and resolving swelling. Due to the high price and
demand in the global market, trade in Panax notoginseng root and rhizome has been complicated by
substitution, adulteration and species identification issues. The genuine material is often replaced by
less valuable material(s), some of which exhibit potentially toxic properties. Therefore, the establishment
of an international standard for Panax notoginseng root and rhizome is necessary to support the clinical
effectiveness, safety and consistency of this valuable medicine in international trade.
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INTERNATIONAL STANDARD ISO 20409:2017(E)
Traditional Chinese medicine — Panax notoginseng root
and rhizome
1 Scope
This document specifies minimum requirements and test methods for notoginseng root and rhizome
which are derived from the plant Panax notoginseng (Burk.) F.H. Chen.
It is applicable to notoginseng root and rhizome that are sold and used as food supplements, functional
food or 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 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
CODEX STAN 229-1993, REV.1-2003: Analysis of pesticide residues: Recommended methods
CODEX STAN 1-1985: Codex general standard for the labelling of prepackaged foods
CAC/MRL01-2009: Maximum Residue Limits for Pesticides in Foods
World Health Organization 2011: Quality control methods for herbal materials, General advice on sampling
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:
— IEC Electropedia: available at http:// www.e lectropedia. org/
— ISO Online browsing platform: available at http:// www. iso. org/o bp
3.1
notoginseng
plant of Panax notoginseng (Burk.) F. H. Chen that has been cultivated for at least three years
3.2
root weight
average weight of final samples of root
3.3
root length
largest distance from the bottom to the stem scar of the tap root
Note 1 to entry: See Figure 1.
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ISO 20409:2017(E)

3.4
root diameter
diameter of the tap root
3.5
root number per 500 g
number of tap roots per 500 g
3.6
batch
samples collected from the same particular place at the same time
Note 1 to entry: This is not more than 5 000 kg.
3.7
final sample
samples after the final sampling
4 Descriptions
In this document, dried notoginseng root and rhizome consist of tap root, lateral root and rhizome, as
shown in Figure 1.
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ISO 20409:2017(E)

a) Plant of Panax notoginseng b) Dried tap root
c) Transverse section of the tap root d) Dried rhizome
Key
1 fruit 8 rootlets 15 ray
2 flower 9 tap root length 16 xylem
3 leaf 10 stem scar 17 central cylinder
4 stem 11 warty protrusion 18 stem scar
5 rhizome 12 lateral root scar 19 strip-shaped protruding
6 tap root 13 epidermis 20 root scar
7 lateral root 14 phloem
Figure 1 — Structure of notoginseng
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ISO 20409:2017(E)

5 Requirements
5.1 General characteristics
The following requirements shall be met before sampling.
a) Notoginseng root and rhizome shall be clean and free from rootlets and foreign matter.
b) The presence of living insects, mouldy root and rhizome and external contaminants which are
visible to the naked eye shall not be permitted.
5.2 Notoginseng root
5.2.1 Morphological features of root
a) The shape of the tap root is subconical or cylindrical as shown in Figure 1 b).
b) The root length is 1 cm to 6 cm long, and the root diameter is 1 cm to 4 cm.
c) The outer surface is greyish-yellow or greyish-brown with intermittent longitudinal wrinkles and
branch root scar.
d) Stem scars at the apex are surrounded by warty protrusions.
e) The texture is heavy and compact.
f) The fracture is greyish-green, yellowish-green or greyish-white with xylem rays distributed
radially.
5.2.2 Moisture
The mass fraction of moisture shall not be more than 12,0 % (w/w).
5.2.3 Total ash
The mass fraction of total ash shall not be more than 6,0 % (w/w).
5.2.4 Acid-insoluble ash
The mass fraction of acid-insoluble ash shall not be more than 1,0 % (w/w).
5.2.5 Ethanol-soluble extractives
The mass fraction of ethanol-soluble extractives shall be more than 16,0 % (w/w).
5.2.6 Identification of notoginsenoside R and ginsenosides Rg , Re, and Rb
1 1 1
The identification of notoginsenoside R and ginsenosides Rg , Re, and Rb with thin-layer
1 1 1
chromatogram (TLC) o
...