ISO 21316:2019

INTERNATIONAL ISO
STANDARD 21316
First edition
2019-02
Traditional Chinese medicine — Isatis
indigotica root
Médecine traditionnelle chinoise — Racine d’Isatis indigotica
Reference number
©
ISO 2019
© ISO 2019
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ii © ISO 2019 – 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
5.1.1 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
Foreword
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iv © ISO 2019 – All rights reserved

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.
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 met
...