ISO 22988:2020

INTERNATIONAL ISO
STANDARD 22988
First edition
2020-01
Traditional Chinese medicine —
Astragalus mongholicus root
Médecine traditionnelle chinoise — Racine d'astragalus
mongholicus
Reference number
©
ISO 2020
© ISO 2020
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ii © ISO 2020 – All rights reserved

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
5.2 Moisture . 4
5.3 Total ash . 4
5.4 Water-soluble extractives . 4
5.5 Thin-layer chromatogram identification . 4
5.6 Total polysaccharides . 4
5.7 Marker compounds . 4
5.8 Heavy metals . 4
5.9 Pesticide residues . 4
5.10 Grade . 4
6 Sampling . 5
7 Test methods . 6
7.1 Macroscopic identification . 6
7.2 Determination of moisture content . 6
7.3 Determination of total ash content. 6
7.4 Determination of water-soluble extractives content . 6
7.5 Thin-layer chromatogram identification . 6
7.6 Determination of total polysaccharides content. 6
7.7 Determination of marker compound content . 6
7.8 Determination of heavy metals content . 6
7.9 Determination of pesticide residues content . 6
7.10 Root diameter . 7
7.11 Root length . 7
8 Test report . 7
9 Packaging, storage and transportation . 7
10 Marking and labelling . 7
Annex A (informative) Determination of moisture content . 8
Annex B (informative) Determination of water-soluble extractives content .9
Annex C (informative) Thin-layer chromatogram identification .10
Annex D (informative) Determination of total polysaccharides content .12
Annex E (informative) Determination of marker compound content .13
Annex F (informative) Reference information of national and regional requirements on
Astragalus root .16
Bibliography .19
Foreword
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iv © ISO 2020 – All rights reserved

Introduction
The Astragalus root (also called Astragali Radix, Milkvetch Root, Huang Qi in Mandarin, or 黄芪 or
黄耆 in Han characters) is one of the most frequently used herbal medicines in traditional Chinese
medicine (TCM).
Of roughly 80 000 TCM formulae recorded in classic TCM books, around 7,3 % contain the Astragalus
root as an ingredient. For example, of 1 493 formulae in the Chinese Pharmacopeia (2015 edition), there
are 202 which contain the Astragalus root (accounting for 13,53 %); among 148 kampo medicines for
prescription from the Ministry of Health, Labour and Welfare (MHLW) of Japan, there are 15 formulae
containing the Astragalus root (accounting for 10,14 %). In the United States, the Astragalus root is
widely sold as a dietary supplement ingredient.
Based on the statistics report for the Department of Market Supervision, Ministry of Commerce of the
People's Republic of China, the volume of Astragalus exported from China in 2015 was 4 477,2 tons,
worth 28,330,614 US$. The destination countries and regions included Malaysia, the United States,
Japan, South Korea, Australia, Thailand, Singapore, Indonesia, Vietnam, Hong Kong and Taiwan.
The Astragalus root has been used in TCM for a very long time and remains a highly valued herb today
because of its significant effects, which include:
— Efficacy supported by modern research: controls inflammation, boosts the immune system, slows
or prevents the growth of tumours, protects the cardiovascular system, regulates and prevents
diabetes and comorbidities related to diabetes, contains antioxidative and anti-ageing capabilities,
heals wounds, alleviates symptoms of chemotherapy, treats cold and flu, and provides supplemental
therapy for chronic asthma.
— Traditional indications: qi deficiency and lack of strength, reduced food intake, sloppy stool, sunken
middle qi, chronic diarrhoea, prolapse of the rectum, bloody stool, flooding and spotting, exterior
deficiency with spontaneous sweating, qi deficiency oedema, interior heat wasting-thirst, blood
deficiency and sallow complexion, hemiplegia, impediment pain, numbness, abscesses and long-
term nonhealed cellulitis caused by diabetic complications.
Two species of Astragalus, namely Astragalus mongholicus and Astragalus membranaceus, are
[1] [2]
included in the British Pharmacopoeia , the Pharmacopoeia of the People's Republic of China , the
[3] [4] [5]
European Pharmacopoeia , the Japanese Pharmacopoeia , the Korean Pharmacopoeia and the
[6]
United States Pharmacopoeia (see Table F.1). This document deals with Astragalus mongholicus;
while ISO/NP 21311 deals with Astragalus membranaceus. These two species are different in terms
of morphology and identification. Astragalus membranaceus has small numbers of large leaflets,
while Astragalus mongholicus has large numbers of small leaflets. These species can be identified and
[7] [8]
differentiated by the HPLC method and DNA barcoding . There are also many other Astragalus
species that are morphologically similar to Astragalus mongholicus, some of which are toxic. The
toxic species of Astragalus include Astragalus emoryanus var. emoryanus, Astragalus emoryanus var.
terlinguensis, Astragalus miser var. oblongifolius, Astragalus miser var. serotinus, Astragalus miser var.
hylophilus, Astragalus michauxii, Astragalus Canadensis, Astragalus oreganus, Astragalus variabilis,
Astragalus strictus, Astragalus hamiensis, Astragalus tibetanus, Astragalus confertus, Astragalus rigidulus,
and Astragalus leucoephalus, which can contain poisonous substances such as miserotoxin, karakin,
[9]
cibarin and hiptugi
...