ISO 21317:2019

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
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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
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This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
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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

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
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).
4 © ISO 2019 – All rights reserved

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.
...