Traditional Chinese medicine -- Dendrobium officinale stem

This document specifies minimum requirements and test methods for Dendrobium officinale stem that is derived from cultivated Dendrobium officinale Kimura et Migo. It is applicable to Dendrobium officinale stem that is sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.

Médecine traditionnelle chinoise -- Tige de Dendrobium officinale

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 21370:2019 - Traditional Chinese medicine -- Dendrobium officinale stem
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INTERNATIONAL ISO
STANDARD 21370
First edition
2019-02
Traditional Chinese medicine —
Dendrobium officinale stem
Médecine traditionnelle chinoise — Tige de Dendrobium officinale
Reference number
ISO 21370:2019(E)
ISO 2019
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ISO 21370:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019

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Published in Switzerland
ii © ISO 2019 – All rights reserved
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ISO 21370:2019(E)
Contents Page

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

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

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

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

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

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

5 Requirements .......................................................................................................................................................................................................... 2

5.1 General characteristics ..................................................................................................................................................................... 2

5.2 Dendrobium officinale stem .......................................................................................................................................................... 3

5.2.1 Morphological features .............................................................................................................................................. 3

5.2.2 Thin-layer chromatogram (TLC) identification ..................................................................................... 3

5.2.3 Moisture .................................................................................................................................................................................. 3

5.2.4 Total ash .................................................................................................................................................................................. 3

5.2.5 Ethanol-soluble extractives .................................................................................................................................... 3

5.2.6 Marker compounds ........................................................................................................................................................ 3

5.2.7 Heavy metals ....................................................................................................................................................................... 3

5.2.8 Pesticide residues ........................................................................................................................................................... 4

6 Sampling ........................................................................................................................................................................................................................ 4

7 Test methods ............................................................................................................................................................................................................. 4

7.1 Macroscopic identification ........................................................................................................................................................... 4

7.2 TLC identification ................................................................................................................................................................................. 4

7.3 Determination of moisture content ...................................................................................................................................... 4

7.4 Determination of total ash ............................................................................................................................................................ 4

7.5 Determination of ethanol-soluble extractives ............................................................................................................. 4

7.6 Determination of marker compounds ................................................................................................................................ 4

7.7 Determination of heavy metals ................................................................................................................................................. 4

7.8 Determination of pesticide residues .................................................................................................................................... 4

8 Test report ................................................................................................................................................................................................................... 4

9 Packaging, storage and transportation ......................................................................................................................................... 5

10 Marking and labelling ..................................................................................................................................................................................... 5

Annex A (informative) TLC identification........................................................................................................................................................ 6

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

Annex C (informative) Determination of polysaccharides ............................................................................................................ 9

Annex D (informative) Determination of mannose and peak area ratio of mannose to glucose ........11

Annex E (informative) Reference values of national and regional limits of moisture, total

ash, ethanol-soluble extractives, polysaccharides, mannose and peak area ratio of

mannose to glucose in Dendrobium officinale stem ......................................................................................................14

Bibliography .............................................................................................................................................................................................................................15

© ISO 2019 – All rights reserved iii
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ISO 21370:2019(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 21370:2019(E)
Introduction

Dendrobium officinale stem, the dried stem of Dendrobium officinale Kimura et Migo, is a widely used

herb medicine in China and many other Asian countries. In traditional Chinese medicine, this herb is

used to treat fever, retching and excessive thirst. Modern pharmacological studies also demonstrate

its great potential in diabetes treatment and immuno-enhancement. Therefore, the market for

Dendrobium officinale has developed very rapidly, as indicated by the increase in yield, production

output and trade volume.

However, there remain many challenges, such as adulteration of similar species and lack of suitable

testing methods for quality assessment. In addition, though Dendrobium officinale has been recorded in

[4]

several pharmacopoeias and standards, such as Chinese Pharmacopoeia , Hong Kong Chinese Materia

[5] [6]

Medica Standards and Taiwan Herbal Pharmacopoeia , specifications and quality requirements of

these standards vary, thus there is a clear and urgent need to develop an international standard for

harmonizing the existing standards, as well as ensuring the safety and effectiveness of Dendrobium

officinale.

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

given in 5.2.3, 5.2.4 and 5.2.5 in their national standards. Examples of national and regional values are

given in Annex E.
© ISO 2019 – All rights reserved v
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INTERNATIONAL STANDARD ISO 21370:2019(E)
Traditional Chinese medicine — Dendrobium officinale
stem
1 Scope

This document specifies minimum requirements and test methods for Dendrobium officinale stem that

is derived from cultivated Dendrobium officinale Kimura et Migo.

It is applicable to Dendrobium officinale stem that is sold and used as 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 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, 2011

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
fresh stem
stem that is newly harvested and has not undergone any processing
3.2
dried stem
stem prepared by cleaning, cutting and then heating or sun-drying
© ISO 2019 – All rights reserved 1
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ISO 21370:2019(E)
3.3
processed stem

stem processed by trimming off the fibrous root and leaves, stir-baking while twisting to a spiral or

spring form and drying

Note 1 to entry: This is the common trade form of dried stem of Dendrobium officinale. It is usually called Tie Pi

Feng Dou in Chinese.
4 Descriptions

Dendrobium officinale stem generally has three trade forms, including fresh stem, dried stem and

processed stem (Tie Pi Feng Dou), as shown in Figure 1.
a) Fresh stem b) Dried stem c) Processed stem (Tie Pi
Feng Dou)
Key
1 node
2 leaf sheath
Figure 1 — Structure of Dendrobium officinale
5 Requirements
5.1 General characteristics
The following requirements shall be met before sampling:
a) Dendrobium officinale stem shall be clean and free from foreign matter.
2 © ISO 2019 – All rights reserved
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ISO 21370:2019(E)

b) The presence of living insects, moulds and external contaminants which are visible to the naked

eye shall not be permitted.
5.2 Dendrobium officinale stem
5.2.1 Morphological features
5.2.1.1 Fresh stem

Cylindrical, circular for cross section. Nodes distinct, unbranched. Purple-dotted leaf sheath. Externally

yellowish-green, striated longitudinally. Odour slight. Taste mild, then sweet and viscous on chewing.

5.2.1.2 Dried stem

Cylindrical, differ in length. Externally greyish-green, yellowish-green or golden yellow, striated

longitudinally, sometimes grey leaf sheath remained. Odour slight. Taste mild, then viscous on chewing.

5.2.1.3 Processed stem

Spiral or spring-like, usually with two to six spires. Texture compact, easily broken, fracture even, grey

to greyish-green. Externally yellowish-green or golden yellow, striated longitudinally, sometimes grey

leaf sheath remained. Odour slight. Taste mild, then viscous on chewing.
5.2.2 Thin-layer chromatogram (TLC) identification

The identification of Dendrobium officinale stem by thin-layer chromatogram (TLC) shall present spots

or bands with the same colour and position corresponding to those of reference standard solution.

5.2.3 Moisture
The mass fraction of moisture should not be more than 14,0 %.
NOTE The fresh stem is exempt from this test.
5.2.4 Total ash
The mass fraction of total ash should not be more than 7,0 %.
NOTE The fresh stem is exempt
...

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