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
Current Stage
9093 - International Standard confirmed
Completion Date
31-Oct-2022
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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
---------------------- Page: 1 ----------------------
ISO 20409:2017(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2017, Published in Switzerland

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ii © ISO 2017 – All rights reserved
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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

iv © ISO 2017 – All rights reserved
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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

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 on 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 the following

URL: w w w . i s o .org/ iso/ foreword .html.

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

© ISO 2017 – All rights reserved v
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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

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.

vi © ISO 2017 – All rights reserved
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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.
2 © ISO 2017 – All rights reserved
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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
...

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