ISO 23193:2020

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 23193
ISO/TC 249
Traditional Chinese medicine — Lycium
Secretariat: SAC
barbarum and Lycium chinense fruit
Voting begins on:
2020­05­08
Médecine traditionnelle chinoise — Baie de goji (baie de Lycium
barbarum et de Lycium chinense)
Voting terminates on:
2020­07­03
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 SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/FDIS 23193:2020(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN­
DARDS TO WHICH REFERENCE MAY BE MADE IN
©
NATIONAL REGULATIONS. ISO 2020

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ISO/FDIS 23193:2020(E)

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© ISO 2020
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ISO/FDIS 23193:2020(E)

Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Descriptions . 2
5 Requirements . 4
5.1 Morphological features . 4
5.1.1 Appearance . 4
5.1.2 Colour . 4
5.1.3 Dimensions . 4
5.1.4 Fracture . 4
5.1.5 Odour . 4
5.2 Microscopic characteristics . 4
5.3 Moisture . 5
5.4 Total ash . 5
5.5 Acid­insoluble ash . 5
5.6 Water-soluble extractives . 5
5.7 Thin-layer chromatogram (TLC) identification . 6
5.8 Content of polysaccharide . 6
5.9 Content of marker compound . 6
5.10 Heavy metals . 6
5.11 Pesticide residues . 6
5.12 Sulfur dioxide residues . 6
6 Sampling . 6
7 Test methods . 7
7.1 Macroscopic identification . 7
7.2 Determination of moisture content . 7
7.3 Determination of total ash content. 7
7.4 Determination of acid­insoluble ash content . 7
7.5 Determination of water-solution extractives content . 7
7.6 TLC identification . 7
7.7 Determination of polysaccharide content . 7
7.8 Determination of marker compound content . 7
7.9 Determination of heavy metals contents . 7
7.10 Determination of pesticide residues contents . 7
7.11 Determination of sulfur dioxide residues contents . 8
8 Test report . 8
9 Packaging, storage and transportation . 8
10 Marking and labelling . 8
Annex A (informative) Determination of water-soluble extractives . 9
Annex B (informative) TLC identification .10
Annex C (informative) Determination of polysaccharide content .11
Annex D (informative) Determination of betaine content .13
Annex E (informative) Reference values of national and regional limits of moisture,
total ash, water-soluble extractives, polysaccharides, betaine contents in Lycium
barbarum and Lycium chinense fruit .16
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ISO/FDIS 23193:2020(E)

Annex F (informative) Reference information and methods for differentiating Lycium
barbarum L. and Lycium chinense Mill.18
Bibliography .19
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ISO/FDIS 23193:2020(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 non­governmental, 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.
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ISO/FDIS 23193:2020(E)

Introduction
Lycium barbarum and Lycium chinense fruit, commonly called Lycium fruit or Lycii Fructus, is the dried
fruit of Lycium barbarum Linné or Lycium chinense Mill. (Fam. Solanaceae). Lycium fruit was firstly
recorded in the book ‘Divine Farmer’s Classic of Materia Medica’, and it has a long history in China, Korea,
Japan and other Southeast Asian nations, where it is used to nourish the liver and kidneys and replenish
essence to improve vision. Clinically, owing to its medicinal properties, it plays an important role in the
treatment of diseases such as immune suppression, cancer and diabetic retinopathy.
Additionally, Lycium barbarum and Lycium chinense fruit, with its sweet taste and warming property,
is widely used in functional food and cosmetics. Lycium fruit and its finished products also have a
very high reputation worldwide for their effectiveness, and account for a large market share in the
international trade of Chinese herbal medicines.
Lycium barbarum and Lycium chinense fruit is widely cultivated in the northwest of China, Korea and
Canada, among other places. However, the quality of Lycium fruit provided from different areas or by
different cultivators is quite different. In addition, though Lycium barbarum and Lycium chinense fruit
has been recorded in several pharmacopeia and standards, specifications and quality requirements
in these standards vary. Thus, there is a clear and urgent need to develop an international standard
for harmonizing the existing standards, as well as ensuring the safety and effectiveness of Lycium
barbarum and Lycium chinense fruit.
As national implementation may differ, national standards bodies are invited to modify the values
given in 5.3, 5.4, 5.5, 5.6, 5.8 and Clause 9 in their national standards. Examples of national and regional
values are given in Annex E.
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FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 23193:2020(E)
Traditional Chinese medicine — Lycium barbarum and
Lycium chinense fruit
1 Scope
This document specifies the minimum requirements and test methods for Lycium barbarum and Lycium
chinense fruit, which is derived from the plant of Lycium barbarum L. or Lycium chinense Mill.
It is applicable to Lycium barbarum and Lycium chinense fruit that is sold and used as herbal raw
materials in the international trade, including unprocessed and traditionally processed materials.
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 18664, Traditional Chinese Medicine — Determination of heavy metals in herbal medicines used in
Traditional Chinese Medicine
ISO 20409, Traditional Chinese medicine — Panax notoginseng root and rhizome
ISO 21371, Traditional Chinese medicine — Labelling requirements of products intended for oral or topical use
1)
ISO 22258, Traditional Chinese medicine — Determination of pesticide residues in natural products by GC
ISO 22590, Traditional Chinese medicine — Determination of sulfur dioxide in natural products by
2)
titration
World Health Organization Quality control methods for herbal materials, 2011
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
Lycium barbarum fruit
dried ripe fruit of Lycium barbarum L. (Fam. Solanaceae)
3.2
Lycium chinense fruit
dried ripe fruit of Lycium chinense Mill. (Fam. Solanaceae)
1) Under preparation. Stage at the time of publication: ISO/FDIS 22258:2020.
2) Under preparation. Stage at the time of publication: ISO/DIS 22590:2020.
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ISO/FDIS 23193:2020(E)

3.3
batch
samples collected from the same particular place at the same time, of no more than 1 000 kg
3.4
final sample
samples for the test required in this document
Note 1 to entry: Final samples may be packed in different materials meeting conditions for specific tests (e.g.
moisture or total ash).
4 Descriptions
The structure of Lycium barbarum L., Lycium chinense Mill. and the dried ripe fruit are shown in Figure 1.
Different features such as leaves, flowers and fruits in Lycium barbarum L. and Lycium chinense Mill.,
and methods for differentiating these two species, are given in Annex F.
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ISO/FDIS 23193:2020(E)

a)  Plant of Lycium barbarum L. b)  Plant of Lycium Chinese Mill.
c)  Dried ripe fruits (upper: Lycium barbarum fruit; lower: Lycium chinense fruit)
Key
1 fruit spur
2 flower
3 corolla expended to show stamens
4 stamen
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ISO/FDIS 23193:2020(E)

5 pistil
6 pistil stalk scar
7 fruit stalk scar
Figure 1 — Structure of Lycium barbarum and Lycium chinense fruit
5 Requirements
5.1 Morphological features
5.1.1 Appearance
The fruit is nearly fusiform or elliptical. Pericarp is soft and externally roughly wrinkled. Sarcocarp is
pulpy, soft and tender.
5.1.2 Colour
The external surface is red or dark red with a pistil stalk scar (6) at the apex and a white fruit stalk scar
(7) at the base, as in Figure 1 c).
5.1.3 Dimensions
The fruit is 6 mm to 20 mm in length measured from the base to the end of the fruit and 3 mm to 10 mm
in diameter measured at the base of the fruit.
5.1.4 Fracture
20 to 50 seeds are present inside one fruit, kidney-shaped and nearly flat, ca. 2 mm; the external surface
of the seeds is pale yellow or yellowish brown in the fruit of Lycium barbarum L., while the seeds in
one fruit of Lycium chinense Mill. are numerous, kidney-shaped and nearly flat, 2,5 mm to 3 mm; the
external surface colour of the seeds is yellow.
5.1.5 Odour
The odour is slight, and the taste is at first sweet and then slightly bitter for Lycium chinense fruit, and
sweet and not bitter for Lycium barbarum fruit.
5.2 Microscopic characteristics
See Figure 2. The powder is yellowish­orange or reddish­brown. Epidermal cells of outer pericarp (1)
are polygonal or elongated-polygonal, about 60 μm in diameter, with straight or slightly wavy walls,
covered with a thick cuticle, with distinct, more­or­less parallel striations. Parenchymatous cells of
mesocarp (2) are thin­walled subpolygonal, containing reddish­orange or brownish­red spherical
aleurone granules (3). Fragments of starch
...