ISO 22212:2019

INTERNATIONAL ISO
STANDARD 22212
First edition
2019-03
Traditional Chinese medicine —
Gastrodia elata tuber
Médecine traditionnelle chinoise — Tubercule de Gastrodia elata
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 . 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
Foreword
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iv © ISO 2019 – All rights reserved

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.
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.
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

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
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
...