ISO 22988:2020

Traditional Chinese medicine - Astragalus mongholicus root

This document specifies the quality and safety requirements of Astragalus mongholicus root [root of Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao]. This document applies to Astragalus mongholicus root that is sold and used as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.

Médecine traditionnelle chinoise — Racine d'astragalus mongholicus

General Information

• Status: Published
• Publication Date: 08-Jan-2020
• ICS: 11.120.10 - Medicaments
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249/WG 1 - Quality and safety of raw materials and traditional processing
• Current Stage: 9060 - Close of review
• Completion Date: 02-Sep-2030

Overview

ISO 22988:2020 - Traditional Chinese medicine - Astragalus mongholicus root - is an international standard that defines quality and safety requirements for dried Astragalus mongholicus root (the herbal drug often called Huang Qi, Astragali Radix). The standard applies to Astragalus mongholicus root sold or used as natural medicine in international trade, including whole Chinese materia medica and decoction pieces. ISO 22988:2020 helps ensure consistent identity, safety and suitability of Astragalus root in global commerce and clinical use.

Key topics and technical requirements

ISO 22988:2020 covers identification, compositional tests and safety controls with detailed test methods and sampling procedures. Major technical topics include:

• Morphological features: macroscopic descriptions and root structure (tap root, fibrous roots, epidermis, phloem, xylem).
• Identity and chemical markers: identification by thin-layer chromatography and quantification of marker compounds such as astragaloside I, II and IV; calycosin, calycosin-7-glucoside, formononetin and ononin.
• Quality parameters: determination of total polysaccharides, water-soluble extractives, total ash and moisture content.
• Safety limits and testing: procedures for heavy metals and pesticide residues analysis to ensure consumer safety.
• Physical specifications: sampling rules, root length and diameter measurements, and grade classifications.
• Test methods and reporting: defined laboratory methods (TLC, gravimetric, HPLC/DNA methods referenced where applicable) and required test reports.
• Packaging, storage and labelling: guidance for protecting quality during transport and sale; labelling requirements for oral or topical TCM products.

Note: ISO provides methods and reference requirements; national/regional bodies may adapt numerical values (see Annex F for examples).

Practical applications and intended users

ISO 22988:2020 is useful for:

• Manufacturers and processors of decoction pieces and herbal medicines to implement consistent quality control.
• Quality control laboratories performing identity, purity and contaminant testing.
• Exporters and importers engaged in international trade who must meet importing-country requirements.
• Regulators and pharmacopoeia committees harmonizing safety standards for Traditional Chinese Medicine (TCM).
• Practitioners and formulary developers seeking assurance of raw material consistency.

Adoption of ISO 22988 supports product safety, regulatory compliance, traceability and consumer confidence in Astragalus mongholicus root.

Related standards

Relevant documents referenced in ISO 22988 include:

• ISO 1575 (total ash), ISO 18664 (heavy metals in TCM), ISO 21371 (labelling), ISO 22217 / ISO 22258 (storage and pesticide determination) and WHO Quality control methods for herbal materials. These help implement the standard’s testing, storage and labelling provisions.

Standards Content (Sample)

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
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
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below or ISO’s member body in the country of the requester.
ISO copyright office
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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
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
constitute an endorsement.
For an explanation of 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 www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
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 hiptugin . Thus, the establishment of an ISO standard for Astragalus mongholicus root is
necessary to ensure the quality and safe use of this herb.
The misuse of such species in TCM remains a problem resulting in questions about the effectiveness
or unexpected side-effects of Astragalus mongholicus and Astragalus membranaceus. The establishment
of an international standard for Astragalus mongholicus root is therefore necessary to guarantee the
clinical effectiveness, safety and controllability of this valuable medicine in global commerce and trade.
Reference information on the use of Astragalus root in different countries and regions is included in
Annex F.
As national implementation may differ, national standards bodies are invited to modify the values
given in 5.2, 5.3 and 5.4 in their national standards. Examples of national and regional values are given
in Annex F.
vi © ISO 2020 – All rights reserved

INTERNATIONAL STANDARD ISO 22988:2020(E)
Traditional Chinese medicine — Astragalus mongholicus
root
1 Scope
This document specifies the quality and safety requirements of Astragalus mongholicus root [root of
Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao].
This document applies to Astragalus mongholicus root that is sold and used as natural medicine 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 18664, Traditional Chinese Medicine — Determination of heavy metals in herbal medicines used in
Traditional Chinese Medicine
ISO 21371, Traditional Chinese medicine — Labelling requirements of products intended for oral or topical use
1)
ISO 22217, Traditional Chinese medicine — Storage requirements for raw materials and decoction pieces
2)
ISO 22258, Traditional Chinese medicine — Determination of pesticide residues in natural products by GC
World Health Organization 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:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
Astragalus mongholicus root
dried root of Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao
Note 1 to entry: For synonyms of the Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao, see
Table F.1.
3.2
root length
distance from the bottom to the stem scar of the tap root, in centimetres
1) Under preparation. Stage at the time of publication: ISO/DIS 22217:2019.
2) Under preparation. Stage at the time of publication: ISO/DIS 22258:2019.
3.3
root diameter
diameter of the tap root, in centimetres
3.4
root top diameter
diameter of the tap root at the stem scar of the tap root, in centimetres
3.5
root mid-diameter
diameter of the tap root at the mid-length of the tap root, in centimetres
3.6
root bottom diameter
diameter of the tap root at the bottom of the tap root, in centimetres
3.7
marker compound
astragaloside I (C H O ), astragaloside II (C H O ), astragaloside IV (C H O ), calycosin
45 72 16 43 70 15 41 68 14
(C H O ), calycosin-7-glucoside (C H O ), formononetin (C H O ), and ononin (C H O )
16 12 5 22 22 10 16 12 4 22 22 9
3.8
batch
samples collected from the same particular place at the same time, of no more than 5 000 kg
4 Descriptions
In this document, Astragalus mongholicus root is the dried root of Astragalus membranaceus (Fisch.)
Bge. var. mongholicus (Bge.) Hsiao in the family of Leguminosae shown in Figure 1.
2 © ISO 2020 – All rights reserved

Key
A plant of Astragalus mongholicus 4 fibrous root
B dried tap root 5 tap root
C longitudinal section of the tap root 6 epidermis
D slanting section of the tap root 7 phloem
E transverse section of the tap root 8 cambium
1 flower 9 xylem
2 leaf 10 radiate striations
3 stem scar
Figure 1 — Structure of Astragalus mongholicus root
5 Requirements
5.1 Morphological features
a) The roots are cylindrical, some branched, upper part relatively thick.
b) The roots are 30 cm to 90 cm long, 1 cm to 3,5 cm in diameter.
c) The outer surface is pale brownish-yellow or pale brown, with irregular, longitudinal wrinkles or
furrows.
d) The texture is hard and tenacious, uneasily broken.
e) The fracture is highly fibrous and starchy, bark yellowish-white, wood pale yellow, with radiate
striations and fissures, the centre part of old root occasionally rotten wood-shaped, blackish-
brown or hollowed.
f) The odour is weak.
g) The taste is slightly sweet and slightly bean-like on chewing.
5.2 Moisture
The content of moisture in percentage mass should not be more than 10,0 %.
5.3 Total ash
The content of total ash in percentage mass should not be more than 5,0 %.
5.4 Water-soluble extractives
The content of water-soluble extractives in percentage mass should not be less than 17,0 %.
5.5 Thin-layer chromatogram identification
The thin-layer chromatogram (TLC) of Astragalus mongholicus root shall present the spots and bands
with the same colour and position corresponding to those of reference solutions.
5.6 Total polysaccharides
The content of total polysaccharides in percentage mass shall be determined.
5.7 Marker compounds
The content of marker compounds in percentage mass shall be determined.
For example, saponins (such as astragaloside I, astragaloside II or astragaloside IV) or isoflavonoids
(such as calycosin, calycosin-7-glucoside, formononetin or ononin) shall be determined according to
relevant national or regional pharmacopoeias.
5.8 Heavy metals
The content of heavy metals including arsenic, mercury, lead and cadmium shall be determined.
5.9 Pesticide residues
The content of pesticide residues shall be determined.
5.10 Grade
The grade of Astragalus mongholicus root shall be established only when all four requirements, i.e. root
top diameter, root mid-diameter, root bottom diameter and root length, are met. The root diameter and
root length of each batch of Astragalus mongholicus root shall conform to the requirements in Table 1.
4 © ISO 2020 – All rights reserved

Table 1 — Grading requirements of Astragalus mongholicus root
Root diameter
Root length
Grade
cm
cm
Root top diameter Root mid-diameter Root bottom diameter
First > 2 > 2 ≥ 0,6 > 70
Second > 1,5 > 1,5 ≥ 0,5 > 50
Third > 1 > 1 ≥ 0,4 > 40
Fourth > 0,7 > 0,7 ≥ 0,3 —
Unqualified ≤ 0,7 ≤ 0,7 < 0,3 —
NOTE 1  The requirements are based on roots collected from different production regions of Astragalus mongholicus root.
NOTE 2  The grading requirements are established according to the traditional grading system of Astragalus mongholicus
root that has long been extensively used in the market and trading and that has also been adopted by the national standards
of the People’s Republic of China.
NOTE 3  Traditionally and practically, the market price of Astragalus mongholicus root is positively correlated with the
grades. The higher the grade, the more expensive the price in the market.
NOTE 4  The grade merely reflects size and TCM knowledge of the product, which has no clear relationship with its efficacy
and safety.
...