Traditional Chinese medicine -- Gastrodia elata tuber

This document specifies minimum requirements and test methods for Gastrodia elata tuber that is derived from cultivated and artificially propagated Gastrodia elata Bl. It is applicable to Gastrodia elata tuber that is sold and used as Chinese materia medica, specifically excluding the wild forms of the species.

Médecine traditionnelle chinoise -- Tubercule de Gastrodia elata

General Information

Status
Published
Publication Date
07-Mar-2019
Current Stage
6060 - International Standard published
Start Date
27-Jan-2019
Completion Date
08-Mar-2019
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ISO 22212:2019 - Traditional Chinese medicine -- Gastrodia elata tuber
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INTERNATIONAL ISO
STANDARD 22212
First edition
2019-03
Traditional Chinese medicine —
Gastrodia elata tuber
Médecine traditionnelle chinoise — Tubercule de Gastrodia elata
Reference number
ISO 22212:2019(E)
ISO 2019
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ISO 22212:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

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ii © ISO 2019 – All rights reserved
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ISO 22212:2019(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Descriptions .............................................................................................................................................................................................................. 2

5 Requirements .......................................................................................................................................................................................................... 4

5.1 General characteristics ..................................................................................................................................................................... 4

5.2 Morphological features .................................................................................................................................................................... 4

5.3 Moisture ........................................................................................................................................................................................................ 4

5.4 Total ash ........................................................................................................................................................................................................ 4

5.5 Dilute ethanol-soluble extract ................................................................................................................................................... 4

5.6 Identification of marker compound(s)............................................................................................................................... 4

5.7 Content of marker compound(s) ............................................................................................................................................. 4

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

5.9 Pesticide residues ................................................................................................................................................................................. 5

5.10 Sulfur dioxide ........................................................................................................................................................................................... 5

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........................................................................................................................................ 6

7.4 Determination of dilute ethanol-soluble extract content ................................................................................... 6

7.5 Identification of marker compound(s)............................................................................................................................... 6

7.6 Determination of marker compound(s) content ....................................................................................................... 6

7.7 Determination of heavy metals ................................................................................................................................................. 6

7.8 Determination of pesticide residues .................................................................................................................................... 6

7.9 Determination of sulfur dioxide content .......................................................................................................................... 6

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

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

10 Marking and labelling ..................................................................................................................................................................................... 7

Annex A (informative) Determination of moisture content ......................................................................................................... 8

Annex B (informative) Determination of dilute ethanol-soluble extract content .................................................9

Annex C (informative) Identification of gastrodin ..............................................................................................................................10

Annex D (informative) Identification of p-hydroxybenzyl alcohol .....................................................................................12

Annex E (informative) Determination of gastrodin and p-hydroxybenzyl alcohol contents ...................14

Annex F (informative) Reference values of national and regional limits in Gastrodia elata tuber ..17

Bibliography .............................................................................................................................................................................................................................18

© ISO 2019 – All rights reserved iii
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ISO 22212:2019(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 22212:2019(E)
Introduction

Gastrodia elata tuber, the dried tuber of Gastrodia elata Bl. (Orchidaceae) after it has been steamed

thoroughly, is a medicinal herb which has been used as an anticonvulsant, analgesic and sedative to

treat general paralysis, epilepsy, tetanus and vertigo in Asian countries for thousands of years.

There are at least 16 countries and regions using Gastrodia elata tuber and its products. Major users

include China, Japan, South Korea, the United State, Australia, Austria and Singapore. Due to its great

demand and high price in the global market, trade in Gastrodia elata tuber has been complicated by

adulteration, substitution and species identification issues. The toxic roots of other species, such as the

plants of the Phytolaccaceae family, are sometimes misused as Gastrodia elata tuber, which can cause

health risks. Factors including contamination, packaging and storage conditions also affect the quality

of Gastrodia elata tuber.

The establishment of an international standard for Gastrodia elata tuber is therefore necessary to

support its quality consistency, clinical effectiveness and safety in international trade.

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

given in 5.3, 5.4, 5.5 and 5.7 in their national standards. Examples of national and regional values are

given in Annex F.
© ISO 2019 – All rights reserved v
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INTERNATIONAL STANDARD ISO 22212:2019(E)
Traditional Chinese medicine — Gastrodia elata tuber
1 Scope

This document specifies minimum requirements and test methods for Gastrodia elata tuber that is

derived from cultivated and artificially propagated Gastrodia elata Bl.

It is applicable to Gastrodia elata tuber that is sold and used as Chinese materia medica, specifically

excluding the wild forms of the species.
2 Normative references
ISO 1575, Tea — Determination of total ash

ISO 5379, Starches and derived products — Determination of sulfur dioxide content — Acidimetric method

and nephelometric method

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

CODEX STAN 229-1993, REV.1-2003, Analysis of pesticide residues: Recommended methods

CAC/MRL01-2009, Maximum Residue Limits for Pesticides in Foods
World Health Organization. 2011, Quality control methods for herbal materials
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
Gastrodia elata tuber

dried tuber of Gastrodia elata Bl. (Orchidaceae) after it has been steamed or boiled thoroughly

3.2
bud

undeveloped or embryonic shoot in red-brown to dark brown, which is parrot-beak-shaped and grows

on the apex of the tuber
Note 1 to entry: See Figure 1.
3.3
latent bud

bud which remains undeveloped or dormant, arranged along the body of Gastrodia elata tuber

Note 1 to entry: See Figure 1.
© ISO 2019 – All rights reserved 1
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ISO 22212:2019(E)
3.4
sample
portion taken from the batch (3.5) during one single sampling action
3.5
batch
samples (3.4) collected from the same particular place at the same time
Note 1 to entry: This is not more than 5 000 kg.
3.6
final sample
samples (3.4) for the test required in this standard

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

moisture or total ash).
4 Descriptions

Gastrodia elata tuber is the dried tuber of Gastrodia elata Bl. (Orchidaceae) after it has been steamed or

boiled thoroughly, as shown in Figure 1.
2 © ISO 2019 – All rights reserved
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ISO 22212:2019(E)
A B C
Key
A front view
B lateral view
C cross-sectional view
1 bud or remain of stem
2 latent bud
3 longitudinal wrinkle
4 rounded scar
5 tuber width
6 tuber length
7 tuber thickness
8 epidermis
9 hypodermis
10 stele
11 vascular bundle
Figure 1 — Structure of Gastrodia elata tuber
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ISO 22212:2019(E)
5 Requirements
5.1 General characteristics
The following requirements shall be met before sampling:
a) Gastrodia elata tuber shall be clean and free from foreign matter;

b) the presence of living insects, mouldy tuber and external contaminants which are visible to the

naked eye shall not be permitted.
5.2 Morphological features

a) The tuber is ellipsoid or slat-shaped, slightly compressed, shrunken and somewhat curved.

b) The tuber is 3 cm to 15 cm long, 1,5 cm to 6 cm wide, and 0,5 cm to 4 cm thick.

c) The tuber mass is no less than 12 g.

d) The outer surface is yellowish-white to pale yellowish-brown, with longitudinal wrinkles and many

transverse annulations arranged along latent buds. The brown thread is sometimes visible. There

are reddish-brown to deep brown parrot-beak-shaped buds or remains of stem on the apex. There

is a rounded scar at the lower end of the tuber.
e) The texture is hard and uneasily broken.
f) The fracture is fairly even, yellowish-white to brownish, and horny.
g) The odour is slight, and the taste is sweetish.
5.3 Moisture
The mass fraction of moisture should not be more than 15,0 %.
5.4 Total ash
The mass fraction of total ash should not be more than 4,5 %.
5.5 Dilute ethanol-soluble extract

The mass fraction of dilute ethanol-soluble extract should not be less than 15,0 %.

5.6 Identification of marker compound(s)

The identification of marker compound(s), such as gastrodin or p-hydroxybenzyl alcohol, with thin-

layer chromatography (TLC) shall present the spots or brands obtained from the test and reference

solutions in the same position with the same colour.
5.7 Content of marker compound(s)

The content of marker compound(s) should be determined. For example, the sum of the mass fraction of

gastrodin and p-hydroxybenzyl alcohol should not be less than 0,25 %.
5.8 Heavy metals
The contents of heavy metals including arsenic, mercury, lead and cadmium
...

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