ISO/FDIS 21370

ISO/DISFDIS 21370
ISO/TC 249/SC 1
Secretariat: SAC
Date: 2025-08-2510-09
Traditional Chinese medicine — Dendrobium officinale stem
Médecine traditionnelle chinoise — Tige de Dendrobium officinale
DISFDIS stage
Warning for WD’s and CD’s
This document is not an ISO International Standard. It is distributed for review and comment. It is subject to change
without notice and may not be referred to as an International Standard.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which
they are aware and to provide supporting documentation.

ISO/DISFDIS 21370:2025(en)
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ii
ISO/DISFDIS 21370:2025(en)
Contents
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Descriptions . 2
5 Quality and safety requirements and recommendations . 4
5.1 General characteristics . 4
5.2 Morphological features . 4
5.3 Thin-layer chromatography (TLC) identification . 4
5.4 Moisture . 4
5.5 Total ash . 4
5.6 Ethanol-soluble extractives. 4
5.7 Marker compounds . 5
5.8 Heavy metals . 5
5.9 Pesticide residues . 5
6 Sampling . 5
7 Test methods . 5
7.1 Macroscopic identification . 5
7.2 TLC identification. 5
7.3 Determination of moisture content . 5
7.4 Determination of total ash . 5
7.5 Determination of ethanol-soluble extractives . 5
7.6 Determination of marker compounds . 5
7.7 Determination of heavy metals. 5
7.8 Determination of pesticide residues . 5
8 Test report . 6
9 Packaging, storage and transportation . 6
10 Marking and labelling . 6
Annex A (informative) TLC identification . 7
Annex B (informative) Determination of polysaccharides . 9
Annex C (informative) Determination of mannose and peak area ratio of mannose to glucose . 11
Annex D (informative) Reference information of national and regional requirements . 14
Bibliography . 15

iii
ISO/DISFDIS 21370:2025(en)
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
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ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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This document was prepared by Technical Committee ISO/TC 249, Traditional medicine, Subcommittee SC 1,
Traditional Chinese medicine.
This second edition cancels and replaces the first edition (ISO 21370:2019), which has been technically
revised.
The main changes are as follows:
— addition of the definition of "stem" in 3.1;
— addition of the definition of "Dendrobium officinale stem" in 3.2;
— update of Normative references and Bibliography;
— Clause 4: insertion of Figure 1 a) "plant of Dendrobium officinale stem';
— Annex D: update of the edition date of the Chinese Pharmacopoeia; addition of the data from the Korean
Herbal Pharmacopoeia; removal of all data from Taiwan Herbal Pharmacopoeia.
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/DISFDIS 21370:2025(en)
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, also known as Tiepishihu in Chinese. 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 several
[1] [2]
pharmacopoeias and standards, such as Chinese Pharmacopoeia , the Korean Herbal Pharmacopoeia and
[3]
Hong Kong Chinese Materia Medica Standards , specifications and quality requirements of these standards
vary, thus there is a clear and urgent need to develop an international standardInternational Standard for
harmonizing the existing standards, as well as ensuring the safety and effectiveness of Dendrobium officinale.
As national implementation can differ, national standards bodies are invited to modify the values given in 5.4,
5.5 and 5.6 in their national standards. Examples of national and regional values are given in Annex D.
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ISO/DISFDIS 21370:2025(en)
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 18664, Traditional Chinese Medicine — Determination of heavy metals in herbal medicines used in
Traditional Chinese Medicine
ISO 19609-2, Traditional Chinese medicine — Quality and safety of raw materials and finished products made
with raw materials — Part 2: Identity testing of constituents of herbal origin
ISO 21371, Traditional Chinese medicine — Labelling requirements of products intended for oral or topical use
ISO 22217, Traditional Chinese medicine —Storage requirements for raw materials and decoction pieces
ISO 22258, Traditional Chinese medicine — Determination of pesticide residues in natural products by gas
chromatography
ISO 23723, Traditional Chinese medicine — General requirements for herbal raw material and materia medica
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at httphttps://www.electropedia.org/
Field Code Changed
3.1
stem
generally cylindrical organ that bears leaves, typically functioning in support and elevation of leaves and
reproductive structures and in conduction of water, minerals, and sugars; in vascular plants initially derived
from the epicotyl of the embryo and generally growing upward. (plant part)
[SOURCE: Simpson (2019)]
3.23.1
Dendrobium officinale stem
stem () of Dendrobium officinale Kimura et Migo, including fresh stem (3.2), dried stem (3.3) and processed stem
(3.4) and processed stem ()
ISO/DISFDIS 21370:2025(en)
3.33.2
fresh stem
stem that is newly harvested and has not undergone any processing
3.43.3
dried stem
stem prepared by cleaning, cutting and then heating or sun-drying
3.53.4
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 Tiepi Fengdou
in Chinese.
4 Descriptions
Dendrobium officinale stem generally has three trade forms, including fresh stem, dried stem and processed
stem (Tiepi Fengdou), as shown in Figure 1.
ISO/DISFDIS 21370:2025(en)
Inserted Cells
Inserted Cells
Inserted Cells
a) plantPlant of Dendrobium officinale stem b) freshFresh stem c) driedDried stem d) processedProcessed
stem (Tiepi
Fengdou)
Key
1 leaf
2 leaf sheath
3 root
4 node
ISO/DISFDIS 21370:2025(en)
Figure 1 — Structure of Dendrobium officinale
5 Quality and safety requirements and recommendations
5.1 General characteristics
The following requirements shall be met before sampling:
a) Dendrobium officinale stem shall be clean and free from foreign matter.
b) The presence of living insects, moulds and external contaminants which are visible to the naked eye shall
not be permitted.
5.2 Morphological features
5.2.1 Fresh stem
The stem is cylindrical. The nodes are distinct and unbranched. The leaf sheath is adorned with purple dots.
Externally, it appears yellowish-green with longitudinal stripes. The odour is slight, while the taste is mild
initially, becoming sweet and viscous upon chewing.
5.2.2 Dried stem
The stem is cylindrical and vary in length. Externally, it is greyish-green, yellowish-green, or golden yellow,
with longitudinal stripes. Sometimes, a grey leaf sheath remains attached. The odour is slight. The taste is mild
initially, becoming viscous upon chewing.
5.2.3 Processed stem
It is spiral or spring-like, usually with 2 to 6 sp
...