ISO 8071:2024
(Main)Traditional Chinese medicine — Ligusticum chuanxiong rhizome
Traditional Chinese medicine — Ligusticum chuanxiong rhizome
This document specifies the quality requirements of Ligusticum chuanxiong rhizome (rhizome of Ligusticum chuanxiong Hort.). This document applies to Ligusticum chuanxiong rhizome that is sold and used as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this rhizome.
Médecine traditionnelle chinoise — Rhizome de livèche du Sichuan (Ligusticum chuanxiong)
General Information
Standards Content (Sample)
International
Standard
ISO 8071
First edition
Traditional Chinese medicine —
2024-03
Ligusticum chuanxiong rhizome
Médecine traditionnelle chinoise — Rhizome de livèche du
Sichuan (Ligusticum chuanxiong)
Reference number
© ISO 2024
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ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Descriptions . 1
5 Requirements and recommendations . 2
5.1 General .2
5.2 Morphological features .2
5.3 Microscopic features .3
5.4 Marker compound .4
5.5 Extractives .4
5.6 Total ash .4
5.7 Acid-insoluble ash .4
5.8 Moisture .4
5.9 Essential oil.4
5.10 Foreign matter .4
5.11 Heavy metals .4
5.12 Pesticide residues .4
5.13 Sulfur dioxide . .4
5.14 Aflatoxin .4
6 Sampling . 4
7 Test methods . 4
7.1 Macroscopic identification .4
7.2 Microscopic identification .5
7.3 Determination of marker compound .5
7.4 Determination of extractives .5
7.5 Determination of total ash .5
7.6 Determination of acid-insoluble ash .5
7.7 Determination of moisture .5
7.8 Determination of essential oil . .5
7.9 Determination of foreign matter .5
7.10 Determination of heavy metals .5
7.11 Determination of pesticide residues .5
7.12 Determination of sulfur dioxide .5
7.13 Determination of aflatoxin .5
8 Test report . 5
9 Marking and labelling . 6
10 Packaging, storage and transportation . 6
Annex A (informative) Determination of ferulic acid . 7
Annex B (informative) Reference of national and regional requirements .11
Annex C (informative) An example of traditional grade information for Ligusticum chuanxiong
rhizome .13
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
Ligusticum chuanxiong rhizome is one of the most commonly used Chinese materia medica in traditional
Chinese medicine. The use of Ligusticum chuanxiong rhizome in medicine was first recorded in Shennong
Bencao Jing (also called Shennong Emperor's Classic of Materia Medica) more than 2 000 years ago. And it
has been artificially planted for traditional Chinese medicine (rhizome) or food (leaf) use as Tao Hongjing
described 1 500 years ago.
Ligusticum chuanxiong rhizome has the effect of activating blood and dissolving stasis, dispelling wind
and relieving pain. Clinically, it is often used with Chinese materia medica for the purpose of awakening,
resuscitation and blood nourishing. It is the main active ingredient in many well-known prescriptions,
such as Siwu decoction and Suxiao Jiuxin pills, and is present in about 30 % of traditional Chinese medicine
[3]
prescriptions. For example, among 1 607 formulae in the Pharmacopoeia of the People's Republic of China ,
246 (15,3 %) contain Ligusticum chuanxiong rhizome.
Ligusticum chuanxiong rhizome and its products are widely used in 13 countries and regions, including Japan,
Malaysia, Singapore, the Republic of Korea and Viet Nam. According to the 'Circulation Market Analysis
Report for Traditional Chinese Medicinal Materials' by the Chinese ministry of commerce, the export volume
of Ligusticum chuanxiong rhizome was 9 160,4 tons in 2014. Therefore, there is clearly a large demand for
Ligusticum chuanxiong rhizome in the international market.
Currently, there is no globally unified standard on the quality, specification and grade of Ligusticum
chuanxiong rhizome. Therefore, creating an International Standard for Ligusticum chuanxiong rhizome is of
great significance.
As national implementation can differ, national standards bodies are invited to modify the values given in
5.4 to 5.10 according to their national requirements. Examples of national and regional values are given in
Annex B. An example of traditional grade information for Ligusticum chuanxiong rhizome is given in Annex C.
v
International Standard ISO 8071:2024(en)
Traditional Chinese medicine — Ligusticum chuanxiong rhizome
1 Scope
This document specifies the quality requirements of Ligusticum chuanxiong rhizome (rhizome of Ligusticum
chuanxiong Hort.).
This document applies to Ligusticum chuanxiong rhizome that is sold and used as natural medicine in
international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces
derived from this rhizome.
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, 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 22283, Traditional Chinese medicine — Determination of aflatoxins in natural products by LC-FLD
ISO 22590, Traditional Chinese medicine — Determination of sulfur dioxide in natural products by titration
ISO 23723, 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
Ligusticum chuanxiong rhizome
dried rhizome of Ligusticum chuanxiong Hort. (Apiaceae), after primary processing
4 Descriptions
Ligusticum chuanxiong rhizome is the dried r
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