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
6060 - International Standard published
Start Date
24-Jan-2019
Completion Date
28-Feb-2019
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ISO 21317:2019 - Traditional Chinese medicine -- Lonicera japonica flower
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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 21317:2019(E)
ISO 2019
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ISO 21317:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

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ii © ISO 2019 – All rights reserved
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ISO 21317:2019(E)
Contents Page

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

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

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

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

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

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

5 Requirements .......................................................................................................................................................................................................... 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

© ISO 2019 – All rights reserved iii
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ISO 21317:2019(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 21317:2019(E)
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.
© ISO 2019 – All rights reserved v
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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

© ISO 2019 – All rights reserved 1
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ISO 21317:2019(E)
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
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ISO 21317:2019(E)
Key
1 Lonicera japonica flower in different flowering stages 6 bract (leaf-like)
2 Lonicera japonica flower selected for medicinal use 7 calyx tube
3 length 8 calyx lobes
4 diameter 9 pistil
5 calyx 10 stamen
Figure 1 — The structure of Lonicera japonica flower
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ISO 21317:2019(E)
5 Requirements
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.

b) Lonicera japonica flower shall be clean and free from foreign matter except for a few leaf-like bracts.

c) The presence of living insects, mould and external contaminants which are visible to the naked eye

shall not be permitted.
5.2 Macroscopic characteristics

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).
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ISO 21317:2019(E)
Key
1 glandular hairs
2 non-glandular hairs
Figure 2 — The structures of glandular hairs and non-glandular hairs
5.4 Moisture

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.
5.5 Total ash

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

The mass fraction of acid-insoluble ash should not be more than 3,0 %. See the values listed in Annex D,

Table D.1 for additional information.
5.7 Dilute ethanol-soluble extract

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) shall

present spots obtained from the test and reference solutions in the same positions with the same

retention values and colour after evenly spraying the chromogenic agent.
© ISO 2019 – All rights reserved 5
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