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
• Start Date: 31-Oct-2022
• Completion Date: 19-Apr-2025

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 2017
© ISO 2017, Published in Switzerland
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ii © ISO 2017 – All rights reserved

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
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

Foreword
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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 documents should be noted. This document was drafted in accordance with the
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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.
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.
vi © ISO 2017 – All rights reserved

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
...