Traditional Chinese medicine — Lonicera japonica flower

This document specifies 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.

Médecine traditionnelle chinoise — Fleur de Lonicera japonica

General Information

Status
Published
Publication Date
27-Feb-2019
Current Stage
9092 - International Standard to be revised
Due Date
05-Feb-2025
Completion Date
05-Feb-2025
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INTERNATIONAL ISO
STANDARD 21317
First edition
2019-02
Traditional Chinese medicine —
Lonicera japonica flower
Médecine traditionnelle chinoise — Fleur de Lonicera japonica
Reference number
©
ISO 2019
© ISO 2019
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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
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 Macroscopic characteristics . 4
5.3 Microscopic characteristics . 4
5.4 Moisture . 5
5.5 Total ash . 5
5.6 Acid-insoluble ash . 5
5.7 Dilute ethanol-soluble extract . 5
5.8 Identification of chlorogenic acid and luteoloside . 5
5.9 Chlorogenic acid content . 6
5.10 Luteoloside content . 6
5.11 Heavy metals content . 6
6 Sampling . 6
7 Test methods . 7
7.1 Macroscopic identification . 7
7.2 Microscopic identification . 7
7.3 Determination of moisture content . 7
7.4 Determination of total ash content. 7
7.5 Determination of acid-insoluble ash content . 7
7.6 Determination of dilute ethanol-soluble extract content . 7
7.7 Identification of chlorogenic acid and luteoloside . 7
7.8 Determination of chlorogenic acid content . 7
7.9 Determination of luteoloside content . 7
7.10 Determination of heavy metals content . 7
8 Test report . 8
9 Packaging, storage and transportation . 8
10 Marking and labelling . 8
Annex A (informative) Identification of chlorogenic acid and luteoloside .9
Annex B (informative) Determination of chlorogenic acid content .11
Annex C (informative) Determination of luteoloside content .13
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 .16
Bibliography .18
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

Introduction
Lonicera japonica flower is the dried flower bud or flower starting to bloom of Lonicera japonica Thunb.,
which is recorded in the Chinese, South Korean, Japanese and United States Pharmacopeias. 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.
1) Quality requirements for Lonicera japonica flower are different among different countries and
regions.
2) Lonicera japonica flower is often substituted with fake and inferior versions.
3) Different collecting times, processing methods, packaging, transportation and storage conditions
often result in different qualities of Lonicera japonica flower.
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 may differ, National Standards Bodies are invited to modify the values
given in 5.4, 5.5, 5.6, 5.7, 5.9 and 5.10 in their national standards. Examples of national and regional
values are given in Annex D.
INTERNATIONAL STANDARD ISO 21317:2019(E)
Traditional Chinese medicine — Lonicera japonica flower
1 Scope
This document specifies 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, Tea — Determination of total ash
ISO 1577, Tea — Determination of acid-insoluble ash
ISO 1666, Starch — Determination of moisture content — Oven-drying method
ISO 18664, Traditional Chinese Medicine — Determination of heavy metals in herbal medicines used in
Traditional Chinese Medicine
World Health Organization. 2011, Quality control methods for herbal materials, General advice on
sampling
CODEX STAN 1: 1985, Codex general standard for the labeling of prepackaged foods
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
dried flower bud or flower starting to bloom of Lonicera japonica Thunb.
3.2
chlorogenic acid content
mass fraction of chlorogenic acid in the sample determined in accordance with Annex B
3.3
luteoloside content
mass fraction of luteoloside in the sample determined in accordance with Annex C
3.4
dilute ethanol-soluble extract
mass fraction of extract obtained from the sample using the method specified in 7.6
3.5
batch
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).
2 © ISO 2019 – All rights reserved

I
...


INTERNATIONAL ISO
STANDARD 21317
First edition
2019-02
Traditional Chinese medicine —
Lonicera japonica flower
Médecine traditionnelle chinoise — Fleur de Lonicera japonica
Reference number
©
ISO 2019
© ISO 2019
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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
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 Macroscopic characteristics . 4
5.3 Microscopic characteristics . 4
5.4 Moisture . 5
5.5 Total ash . 5
5.6 Acid-insoluble ash . 5
5.7 Dilute ethanol-soluble extract . 5
5.8 Identification of chlorogenic acid and luteoloside . 5
5.9 Chlorogenic acid content . 6
5.10 Luteoloside content . 6
5.11 Heavy metals content . 6
6 Sampling . 6
7 Test methods . 7
7.1 Macroscopic identification . 7
7.2 Microscopic identification . 7
7.3 Determination of moisture content . 7
7.4 Determination of total ash content. 7
7.5 Determination of acid-insoluble ash content . 7
7.6 Determination of dilute ethanol-soluble extract content . 7
7.7 Identification of chlorogenic acid and luteoloside . 7
7.8 Determination of chlorogenic acid content . 7
7.9 Determination of luteoloside content . 7
7.10 Determination of heavy metals content . 7
8 Test report . 8
9 Packaging, storage and transportation . 8
10 Marking and labelling . 8
Annex A (informative) Identification of chlorogenic acid and luteoloside .9
Annex B (informative) Determination of chlorogenic acid content .11
Annex C (informative) Determination of luteoloside content .13
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 .16
Bibliography .18
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

Introduction
Lonicera japonica flower is the dried flower bud or flower starting to bloom of Lonicera japonica Thunb.,
which is recorded in the Chinese, South Korean, Japanese and United States Pharmacopeias. 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.
1) Quality requirements for Lonicera japonica flower are different among different countries and
regions.
2) Lonicera japonica flower is often substituted with fake and inferior versions.
3) Different collecting times, processing methods, packaging, transportation and storage conditions
often result in different qualities of Lonicera japonica flower.
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 may differ, National Standards Bodies are invited to modify the values
given in 5.4, 5.5, 5.6, 5.7, 5.9 and 5.10 in their national standards. Examples of national and regional
values are given in Annex D.
INTERNATIONAL STANDARD ISO 21317:2019(E)
Traditional Chinese medicine — Lonicera japonica flower
1 Scope
This document specifies 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, Tea — Determination of total ash
ISO 1577, Tea — Determination of acid-insoluble ash
ISO 1666, Starch — Determination of moisture content — Oven-drying method
ISO 18664, Traditional Chinese Medicine — Determination of heavy metals in herbal medicines used in
Traditional Chinese Medicine
World Health Organization. 2011, Quality control methods for herbal materials, General advice on
sampling
CODEX STAN 1: 1985, Codex general standard for the labeling of prepackaged foods
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
dried flower bud or flower starting to bloom of Lonicera japonica Thunb.
3.2
chlorogenic acid content
mass fraction of chlorogenic acid in the sample determined in accordance with Annex B
3.3
luteoloside content
mass fraction of luteoloside in the sample determined in accordance with Annex C
3.4
dilute ethanol-soluble extract
mass fraction of extract obtained from the sample using the method specified in 7.6
3.5
batch
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).
2 © ISO 2019 – All rights reserved

I
...

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