ISO/FDIS 21317

Formatted: French (France)
ISO/DISFDIS 21317
Formatted: French (France)
ISO/TC 249/SC 1
Secretariat: SAC
Date: 2026-06-1708-19
Traditional Chinese medicine — Lonicera japonica flower
DISFDIS stage
VVVoootttiiing bng bng beeegigiginsnsns o o on:n:n: 202 202 202555---111111---202020
VoVoVotintintinggg t t terererminminminatatateseses o o onnn:::  222000222666---000222---121212

ISO/DISFDIS 21317:2026(en)
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication
may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying,
or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO
at the address below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
Formatted: French (France)
E-mail: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO/DISFDIS 21317:2026(en)
Contents
Foreword . iii
Introduction . iii
Scope . iii
Normative references . iii
Terms and definitions . iii
Descriptions . iii
Requirements and recommendations . iii
General characteristics . iii
Macroscopic characteristics . iii
Microscopic characteristics . iii
Moisture content . iii
Total ash content . iii
Acid-insoluble ash content . iii
Dilute ethanol-soluble extract content . iii
Identification of chlorogenic acid and luteoloside . iii
Content of marker compounds . iii
Heavy metals content . iii
Sampling . iii
Test methods . iii
Macroscopic identification . iii
Microscopic identification . iii
Determination of moisture . iii
Determination of total ash . iii
Determination of acid-insoluble ash . iii
Determination of dilute ethanol-soluble extract . iii
Identification of chlorogenic acid and luteoloside . iii
Determination of marker compounds . iii
Determination of heavy metals . iii
Test report . iii
Packaging, storage and transportation . iii
Marking and labelling . iii
(informative) Identification of chlorogenic acid and luteoloside . iii
(informative) Determination of chlorogenic acid content . iii
(informative) Determination of luteoloside content . iii
(informative) Reference values of national and regional limits of moisture, total ash, acid-
insoluble ash, dilute ethanol-soluble extract, chlorogenic acid, luteoloside and heavy
metals in Lonicera japonica flower . iii
(informative) Reference information for Lonicera macranthoides , Lonicera hypoglauca ,
Lonicera confusa , and Lonicera fulvotomentosa . iii
Bibliography . iii
Foreword . v
Introduction . vii
1 Scope . 1
iii
ISO/DISFDIS 21317:2026(en)
2 Normative references . 1
3 Terms and definitions . 1
4 Descriptions . 2
5 Requirements and recommendations . 5
5.1 General characteristics . 5
5.2 Macroscopic characteristics . 5
5.3 Microscopic characteristics. 5
5.4 Moisture content . 6
5.5 Total ash content . 7
5.6 Acid-insoluble ash content . 7
5.7 Dilute ethanol-soluble extract content . 7
5.8 Identification of chlorogenic acid and luteoloside . 7
5.9 Content of marker compounds . 7
5.10 Heavy metals content . 7
6 Sampling . 7
7 Test methods . 8
7.1 Macroscopic identification . 8
7.2 Microscopic identification . 8
7.3 Determination of moisture . 8
7.4 Determination of total ash . 8
7.5 Determination of acid-insoluble ash . 8
7.6 Determination of dilute ethanol-soluble extract . 8
7.7 Identification of chlorogenic acid and luteoloside . 8
7.8 Determination of marker compounds . 8
7.9 Determination of heavy metals . 8
8 Test report . 8
9 Packaging, storage and transportation . 9
10 Marking and labelling . 9
Annex A (informative) Identification of chlorogenic acid and luteoloside . 10
Annex B (informative) Determination of chlorogenic acid content . 13
Annex C (informative) Determination of luteoloside content . 17
Annex D (informative) Reference values of national and regional limits of moisture, total ash,
acid-insoluble ash, dilute ethanol-soluble extract, chlorogenic acid, luteoloside and
heavy metals in Lonicera japonica flower . 21
Annex E (informative) Reference information for Lonicera macranthoides, Lonicera hypoglauca,
Lonicera confusa, and Lonicera fulvotomentosa . 23
Bibliography . 26

iv
ISO/DISFDIS 21317:2026(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
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 documentsdocument 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).
Field Code Changed
Attention is drawnISO draws attention to the possibility that some of the elementsimplementation of this
document may beinvolve the subjectuse of (a) patent(s). ISO takes no position concerning the evidence,
validity or applicability of any claimed patent rights. in respect thereof. As of the date of publication of this
document, ISO had not received notice of (a) patent(s) which may be required to implement this document.
However, implementers are cautioned that this may not represent the latest information, which may be
obtained from the patent database available at www.iso.org/patents. 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),
see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 249/, Traditional medicine, SC 1, Traditional
Chinese medicine.
This second edition cancels and replaces the first edition (ISO 21317:2019) which has been technically
revised.
The main changes are as follows:
— in Introduction, the Pinyin name (Jinyinhua) of Lonicera japonica flower has been added;
— the normatvie references have been updated;
— in Clause 5, 5.9 and 5.10 have been combined as 5.9;
— in Clause 7, 7.8 and 7.9 have been combined as 7.8;
— in Annex D, the content has been updated, and the information of Lonicera japonica flower recorded in the
European Pharmacopoeia has been added;
— Annex E has been added;
— in Bibliography, the order and content have been updated.
v
ISO/DISFDIS 21317:2026(en)
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.
vi
ISO/DISFDIS 21317:2026(en)
Introduction
Lonicera japonica flower, also known as Jinyinhua, is the dried flower bud or flower starting to bloom of
Lonicera japonica Thunb., which is recorded in the Chinese, Korean, American and European Pharmacopeias
[1][2][3][4] [1] [2] [3] [4] [5] [5]
, and Hong Kong Chinese Materia Medica Standards . Lonicera japonica flower is
internationally recognized as a traditional Chinese herbal medicine, and there is great demand for it in the
international market. However, there are many problems seriously affecting the international trade of
Lonicera japonica flower, including the following.
a) Quality requirements for Lonicera japonica flower are different among different countries and regions.
Formatted: Numbered + Level: 1 + Numbering Style: a,
b, c, … + Start at: 1 + Alignment: Left + Aligned at: 0
b) Lonicera japonica flower is often substituted with fake and inferior versions, such as Lonicera
cm + Indent at: 0 cm
macranthoides, Lonicera hypoglauca, Lonicera confusa, and Lonicera fulvotomentosa flower (also known
Formatted: Numbered + Level: 1 + Numbering Style: a,
as Shanyinhua).
b, c, … + Start at: 2 + Alignment: Left + Aligned at: 0
cm + Indent at: 0 cm
c) Different collecting times, processing methods, packaging, transportation and storage conditions often
Formatted: Numbered + Level: 1 + Numbering Style: a,
result in different qualities of Lonicera japonica flower.
b, c, … + Start at: 3 + Alignment: Left + Aligned at: 0
cm + Indent at: 0 cm
Therefore, the establishment of an international standard for Lonicera japonica flower is necessary to
guarantee the quality, safety and consistency of this valuable herbal medicine. This document includes
sections on morphology evaluation, physicochemical indexes and heavy metals content.
As national implementation maycan differ, national standards bodies are invited to modify the values given in
5.4, 5.5, 5.6 and 5.7 in their national standards. Examples of national and regional values are given in Annex
D.
Lonicera macranthoides, Lonicera hypoglauca, Lonicera confusa, and Lonicera fulvotomentosa flower is
different from Lonicera japonica flower, and the differences are mainly focused on the description,
identification and the determination of marker compounds which are detailed given in Annex E for Lonicera
macranthoides, Lonicera hypoglauca, Lonicera confusa, and Lonicera fulvotomentosa flower.
vii
ISO/DISFDIS 21317:2026(en)
Traditional Chinese medicine — Lonicera japonica flower
1 Scope
This document specifies the minimum requirements and test methods for Lonicera japonica flower, which is
derived from the plant Lonicera japonica Thunb. It is applicable to Lonicera japonica flower that is sold and
used as traditional Chinese medicine.
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 1575:1987, Tea — Determination of total ash
ISO 1577:1987, Tea — Determination of acid-insoluble ash
ISO 1666:1996, Starch — Determination of moisture content — Oven-drying method
ISO 18664:2015, Traditional Chinese Medicine — Determination of heavy metals in herbal medicines used in
Traditional Chinese Medicine
ISO/TS 21310:2025, Traditional Chinese medicine — Microscopic examination of medicinal herbs
ISO 21371:2018, Traditional Chinese medicine — Labelling requirements of products intended for oral or topical
use
ISO 22217:2020, Traditional Chinese medicine —Storage requirements for raw materials and decoction pieces
ISO 23723:2021, 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 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
Lonicera japonica flower, noun
dried flower bud or flower starting to bloom of Lonicera japonica Thunb.
3.2
chlorogenic acid content, noun
mass fraction of chlorogenic acid in the sample
3.3
luteoloside content, noun
mass fraction of luteoloside in the sample
ISO/DISFDIS 21317:2026(en)
3.4
dilute ethanol-soluble extract content, noun
mass fraction of extract obtained from the sample
3.5
batch, noun
samples collected from the same particular place at the same time
4 Descriptions
In this document, Lonicera japonica flower is the dried flower bud or flower starting to bloom of Lonicera
japonica Thunb. It is externally yellowish-white, greenish-white to yellowish-green, gradually darkening over
time to a golden colour (see Figure 1).
ISO/DISFDIS 21317:2026(en)
ISO/DISFDIS 21317:2026(en)
Key
1 Lonicera japonica flower in different flowering stages
2 Lonicera japonica flower selected for medicinal use
3 length
4 diameter
5 calyx
6 bract (leaf-like)
7 calyx tube
8 calyx lobes
9 pistil
10 stamen
ISO/DISFDIS 21317:2026(en)
Figure 1 — The structure of Lonicera japonica flower
5 Requirements and recommendations
5.1 General characteristics
The following requirements shall be met before sampling.
a) Lonicera japonica flower shall be the dried flower bud or flower starting to bloom.
Formatted: Numbered + Level: 1 + Numbering Style: a,
b, c, … + Start at: 1 + Alignment: Left + Aligned at: 0
b) Lonicera japonica flower shall be clean and free from foreign matter except for a few leaf-like bracts. cm + Indent at: 0 cm
Formatted: Numbered + Level: 1 + Numbering Style: a,
c) The presence of living insects, mould and external contaminants which are visible to the naked eye shall
b, c, … + Start at: 2 + Alignment: Left + Aligned at: 0
not be permitted.
cm + Indent at: 0 cm
Formatted: Numbered + Level: 1 + Numbering Style: a,
5.2 Macroscopic characteristics
b, c, … + Start at: 3 + Alignment: Left + Aligned at: 0
cm + Indent at: 0 cm
Flower buds are clavate, tapered downwards, slightly curved; 1,5 cm to 3,5 cm long, about 3 mm in diameter
in the upper part and 1,5 mm in diameter in the lower part, with a densely pubescent surface; externally
yellowish-white or greenish-white, gradually darkening over time to yellowish-brown. The foliaceous bracts
are occasionally visible. The calyx is green, pubescent, five-lobed at the apex and about 2 mm long.
5.3 Microscopic characteristics
Lonicera japonica flower pedicels are covered with numerous glandular hairs and non-glandular hairs. The
heads of glandular hairs are multicellular, turbinate, subround or slightly oblate, usually 30 μm to 70 μm in
diameter, exceptionally up to 110 μm. The stalks of glandular hairs are unicellular or multicellular with up to
five cells, usually 20 μm to 70 μm long, exceptionally up to 700 μm. There are two types of non-glandular hairs:
(i) thick walls, unicellular, 45 μm to 900 μm long, 15 μm to 40 μm in diameter, with fine verrucae on the
surface, some have a corneous spiral; (ii) thin walls, slender, curved or shrinkage, with fine verrucae on the
surface (see Figure 2).
ISO/DISFDIS 21317:2026(en)
Key
1 glandular hairs
2 non-glandular hairs
Figure 2 — The structures of glandular hairs and non-glandular hairs
5.4 Moisture content
The mass fraction of moisture should not be more than 15,0 %. See the values listed in Annex D, Table D.1 for
additional information.
ISO/DISFDIS 21317:2026(en)
5.5 Total ash content
The mass fraction of total ash should not be more than 10,0 %. See the values listed in Annex D, Table D.1 for
additional information.
5.6 Acid-insoluble ash content
The mass fraction of acid-insoluble ash should be determined. See the values listed in Annex D, Table D.1 for
additional information.
5.7 Dilute ethanol-soluble extract content
The mass fraction of dilute ethanol-soluble extract should not be less than 16,0 %. See the values listed in
Annex D, Table D.2 for additional information.
5.8 Identification of chlorogenic acid and luteoloside
The identification of chlorogenic acid and luteoloside with thin layer chromatography (TLC) should present
spots specific to these compounds.
5.9 Content of marker compounds
The mass fraction of marker compounds such as chlorogenic acid and luteoloside should be determined.
5.10 Heavy metals content
Heavy metals such as lead, arsenic, cadmium and mercury should be determined.
6 Sampling
Sampling of Lonicera japonica flower shall be in accordance with the method specified in ISO 23723:2021 .
Formatted: Numbered + Level: 1 + Numbering Style: a,
b, c, … + Start at: 1 + Alignment: Left + Aligned at: 0
a) From a batch of five containers or packaging units, take a sample from each one.
cm + Indent at: 0 cm
Formatted: Numbered + Level: 1 + Numbering Style: a,
b) From a batch of between 6 and 50 units, take a sample from five.
b, c, … + Start at: 2 + Alignment: Left + Aligned at: 0
cm + Indent at: 0 cm
c) From a batch of over 50 units, sample 10 %, rounding up the number of units to the nearest multiple of
10. For example, a batch of 51 units would be sampled as 60 units — i.e. take samples from six packages.
Formatted: Numbered + Level: 1 + Numbering Style: a,
b, c, … + Start at: 3 + Alignment: Left + Aligned at: 0
d) From each selected container or package, take three original samples from the top, middle and bottom of
cm + Indent at: 0 cm
the container or package. The three original samples should then be combined into a pooled sample that
Formatted: Numbered + Level: 1 + Numbering Style: a,
should be carefully mixed.
b, c, … + Start at: 4 + Alignment: Left + Aligned at: 0
cm + Indent at: 0 cm
e) The average sample is obtained by quartering. Take some of the pooled sample, adequately mixed, place
Formatted: Numbered + Level: 1 + Numbering Style: a,
in an even, square-shaped heap and divide this diagonally into four equal parts. Take two diagonally
b, c, … + Start at: 5 + Alignment: Left + Aligned at: 0
opposite parts and mix carefully.
cm + Indent at: 0 cm
f) Repeat the process as necessary until the required quantity, to within ± 10 %, is obtained. Formatted: Numbered + Level: 1 + Numbering Style: a,
b, c, … + Start at: 6 + Alignment: Left + Aligned at: 0
cm + Indent at: 0 cm
g) Using the same quartering procedure, divide the average sample into four final samples, taking care that
each portion is representative of the bulk material.
Formatted: Numbered + Level: 1 + Numbering Style: a,
b, c, … + Start at: 7 + Alignment: Left + Aligned at: 0
h) The final samples are tested for the measurement and analyses specified in Table 1. Ground samples shall
cm + Indent at: 0 cm
be used in the measurement and analyses, except the identification of macroscopic characteristics. The
Formatted: Numbered + Level: 1 + Numbering Style: a,
test samples shall be finely ground into 65 mesh, carefully mixed and sealed.
b, c, … + Start at: 8 + Alignment: Left + Aligned at: 0
cm + Indent at: 0 cm
ISO/DISFDIS 21317:2026(en)
Table 1 — Maximum weight of batch and minimum weight of final sample
Minimum weight of final sample
Maximum weight
g
of batch
For analysis of For analysis of
kg
For other analyses
chlorogenic acid luteoloside
5 000 250 250 250
NOTENOTENOTE Other analyses include the identification of macroscopic and microscopic
...