Traditional Chinese medicine -- Isatis indigotica root

This document specifies the minimum requirements and test methods for Isatis indigotica root derived from the plant Isatis indigotica Fort. It is applicable to Isatis indigotica roots that are sold as Chinese material medica (whole medicinal materials) and decoction pieces derived from this plant.

Médecine traditionnelle chinoise -- Racine d’Isatis indigotica

General Information

Status
Published
Publication Date
04-Feb-2019
Current Stage
6060 - International Standard published
Start Date
12-Nov-2018
Completion Date
05-Feb-2019
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ISO 21316:2019 - Traditional Chinese medicine -- Isatis indigotica root
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INTERNATIONAL ISO
STANDARD 21316
First edition
2019-02
Traditional Chinese medicine — Isatis
indigotica root
Médecine traditionnelle chinoise — Racine d’Isatis indigotica
Reference number
ISO 21316:2019(E)
ISO 2019
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ISO 21316:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019

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ii © ISO 2019 – All rights reserved
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ISO 21316:2019(E)
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

5.1.1 Appearance ........................................................................................................................................................................... 3

5.1.2 Colour ........................................................................................................................................................................................ 3

5.1.3 Dimension .............................................................................................................................................................................. 4

5.1.4 Stem residue ........................................................................................................................................................................ 4

5.1.5 Texture ...................................................................................................................................................................................... 4

5.1.6 Fracture .................................................................................................................................................................................... 4

5.1.7 Odour ......................................................................................................................................................................................... 4

5.2 Moisture ........................................................................................................................................................................................................ 4

5.3 Total ash ........................................................................................................................................................................................................ 4

5.4 Acid-insoluble ash ................................................................................................................................................................................ 4

5.5 Ethanol-soluble extractives .......................................................................................................................................................... 4

5.6 Identification of maker compound ........................................................................................................................................ 4

5.7 Content of marker compound .................................................................................................................................................... 4

5.8 Heavy metals ............................................................................................................................................................................................. 4

5.9 Pesticide residues ................................................................................................................................................................................. 4

6 Sampling ........................................................................................................................................................................................................................ 5

7 Test methods ............................................................................................................................................................................................................. 5

7.1 Macroscopic identification ........................................................................................................................................................... 5

7.2 Determination of moisture content ...................................................................................................................................... 5

7.3 Determination of total ash content........................................................................................................................................ 5

7.4 Determination of acid-insoluble ash content ............................................................................................................... 5

7.5 Determination of ethanol-extractives content............................................................................................................. 6

7.6 Thin-layer chromatogram (TLC) identification .......................................................................................................... 6

7.7 Determination of marker compound content .............................................................................................................. 6

7.8 Determination of heavy metals contents ......................................................................................................................... 6

7.9 Determination of pesticide residues contents ............................................................................................................. 6

8 Test report ................................................................................................................................................................................................................... 6

9 Packaging, storage and transportation ......................................................................................................................................... 6

10 Marking and labelling ..................................................................................................................................................................................... 6

Annex A (informative) Determination of ethanol-soluble extractives .............................................................................. 8

Annex B (informative) Thin-layer chromatogram (TLC) identification ........................................................................... 9

Annex C (informative) Determination of (R,S)-goitrin content .............................................................................................11

Annex D (informative) National and regional limits of moisture, total ash, acid-insoluble

ash, (R,S)-goitrin and ethanol-soluble extractive contents in Isatis indigotica root ...................13

Bibliography .............................................................................................................................................................................................................................14

© ISO 2019 – All rights reserved iii
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ISO 21316:2019(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 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 2019 – All rights reserved
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ISO 21316:2019(E)
Introduction

Isatis indigotica root, dried root of Isatis indigotica Fort. (Fam. Brassicaceae), is one of the most

commonly used herbs in traditional Chinese medicine (TCM). It has a long history of use in East Asian

countries to remove heat and toxins, cool the blood and clear the throat.

Clinically, Isatis indigotica root is recognized as an important traditional Chinese herb for the prevention

and treatment of colds and malignant infectious diseases, especially SARS and H1N1. At present, Isatis

indigotica root and its processed products occupy a huge share of the international market. However,

many problems, such as different quality requirements among different countries and regions,

adulteration with Baphicacanthis root derived from the dried root and rhizome of Baphicacanthus cusia

(Nees) Bremek (Fam. Acanthaceae), and different packaging, transportation and storage conditions,

can affect the quality of Isatis indigotica root.

Therefore, the establishment of an international standard is necessary to establish the quality

requirements of Isatis indigotica root to support its clinical effectiveness and safety. This document

consists of a morphology observation of macroscopic characteristics, phytochemical indexes, and

standardized physical and chemical tests (moisture, total ash and acid-insoluble ash). Glucosinolates

with multi-bioactivities are specific compositions of the plant in the Brassicaceae family. Among them,

(R,S)-goitrin with high specificity reflects bioactivities relevant to the effects of Isatis indigotica root.

Using (R,S)-goitrin as the marker, TLC identification and HPLC assay methods are established in this

document.

As national implementation may differ, National Standards Bodies are invited to modify the values

given in 5.2, 5.3, 5.4 and 5.5 in their national standards. Examples of national and regional values are

given in Annex D.
© ISO 2019 – All rights reserved v
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INTERNATIONAL STANDARD ISO 21316:2019(E)
Traditional Chinese medicine — Isatis indigotica root
1 Scope

This document specifies the minimum requirements and test methods for Isatis indigotica root derived

from the plant Isatis indigotica Fort.

It is applicable to Isatis indigotica roots that are sold as Chinese material 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
ISO 20409, Traditional Chinese medicine — Panax notoginseng root and rhizome

ISO 21371, Traditional Chinese medicine — Labelling requirements of products intended for oral or topical use

CAC/MRL01, Maximum Residue Limits for Pesticides in Foods
CODEX STAN 229, Analysis of pesticide residues: Recommended methods

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
root
dried root of Isatis indigotica Fort. (Fam. Brassicaceae)
3.2
batch

group of samples collected from the same particular place at the same time, no more than 5 000 kg

3.3
final sample
sample for the test required in this document

Note 1 to entry: Final samples may be packed in different materials meeting conditions for specific tests (e.g.

moisture or total ash).
© ISO 2019 – All rights reserved 1
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ISO 21316:2019(E)
4 Descriptions

Isatis indigotica root is the dried root of Isatis indigotica Fort in the family of Brassicaceae as shown in

Figur
...

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