ISO/FDIS 23965

Traditional Chinese medicine -- Bupleurum chinense, Bupleurum scorzonerifolium and Bupleurum falcatum root

Titre manque

General Information

• Status: Published
• ICS: 11.120.10 - Medicaments
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249/WG 1 - Quality and safety of raw materials and traditional processing
• Current Stage: 5020 - FDIS ballot initiated: 2 months. Proof sent to secretariat
• Start Date: 15-Dec-2021
• Completion Date: 15-Dec-2021

Standards Content (sample)

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 23965
ISO/TC 249
Traditional Chinese medicine —
Secretariat: SAC
Bupleurum chinense, Bupleurum
Voting begins on:
2021-12-15 scorzonerifolium and Bupleurum
falcatum root
Voting terminates on:
2022-02-09
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 23965:2021(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 2021
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ISO/FDIS 23965:2021(E)
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© ISO 2021

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© ISO 2021 – All rights reserved
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ISO/FDIS 23965:2021(E)
Contents Page

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

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

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

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

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

4 Description ........................................................................................................................................... ......................................................................2

5 Requirements .......................................................................................................................................................................................................... 4

5.1 General characteristics ................................................................................................................................................................... 4

5.2 Macroscopic characteristics ....................................................................................................................................................... 4

5.2.1 Bupleurum chinense .......................................................................................................................................................... 4

5.2.2 Bupleurum scorzonerifolium ...................................................................................................................................... 4

5.2.3 Bupleurum falcatum ......................................................................................................................................................... 4

5.3 Moisture ....................................................................................................................................................................................................... 4

5.4 Total ash ....................................................................................................................................................................................................... 4

5.5 Acid-insoluble ash ................................................................................................................................................................................ 4

5.6 Thin-layer chromatogram (TLC) identification ........................................................................................................ 5

5.7 Toxic adulterants of Bupleurum longiradiatum root .............................................................................................. 5

5.8 Ethanol-soluble extractives ........................................................................................................................................................ 5

5.9 Content of marker compounds ................................................................................................................................................. 5

5.10 Heavy metals ............................................................................................................................................................................................ 5

5.11 Pesticide residues ................................................................................................................................................................................ 5

5.12 Sulfur dioxide residues ......... ........................................................................................................................................................... 5

6 Sampling ....................................................................................................................................................................................................................... 5

7 Test methods ............................................................................................................................................................................................................ 5

7.1 Macroscopic identification ........................................................................................................................................................... 5

7.2 Determination of moisture content ..................................................................................................................................... 5

7.3 Determination of total ash and acid-insoluble ash content ............................................................................ 5

7.4 Determination of ethanol-soluble extractives content ....................................................................................... 5

7.5 Thin-layer chromatogram (TLC) identification ........................................................................................................ 6

7.6 Identification of the toxic adulterants of Bupleurum longiradiatum root ........................................... 6

7.7 Determination of marker compound(s)............................................................................................................................ 6

7.8 Determination of heavy metals ............................................................................................................................................... 6

7.9 Determination of pesticide residues ................................................................................................................................... 6

7.10 Determination of sulfur dioxide residues ...................................................................................................................... 6

8 Test report .................................................................................................................................................................................................................. 6

9 Packaging, storage and transportation ...................................................................................................................................... 6

10 Marking and labelling .................................................................................................................................................................................... 7

Annex A (informative) Determination of moisture content ....................................................................................................... 8

Annex B (informative) Determination of total ash and acid-insoluble ash content ..........................................9

Annex C (informative) Determination of ethanol-soluble extractives content ...................................................10

Annex D (informative) Thin-layer chromatogram (TLC) identification ....................................................................11

Annex E (informative) Identification of the toxic adulterants of Bupleurum longiradiatum

root ..................................................................................................................................................................................................................................13

Annex F (informative) Determination of marker compounds ..............................................................................................16

Annex G (informative) National and regional requirements for Bupleurum chinense,

Bupleurum scorzonerifolium and Bupleurum falcatum root ...............................................................................19

iii
© ISO 2021 – All rights reserved
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ISO/FDIS 23965:2021(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

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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.

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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.
© ISO 2021 – All rights reserved
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ISO/FDIS 23965:2021(E)
Introduction

Bupleurum chinense, Bupleurum scorzonerifolium and Bupleurum falcatum root, namely Bupleuri Radix,

are well-known traditional Chinese materia medica which have liver-protection, antipyretic and anti-

inflammatory qualities. Bupleuri Radix is sold in many countries as medicinal materials or decoction

pieces. Bupleuri Radix originates from cross-pollinating plants, which can easily lead to a hybrid of

their provenance, in turn resulting in mixed sources of herbs. This can lead to difficulties in herb

authenticity, as well as variations in herb efficacy and safety. Bupleuri Radix is included in several

pharmacopeia, but with different plant origins. Thus, there is a need to standardize the quality to

bring benefits to consumers and the enterprises involved in the processing, management and trade of

Bupleurum chinense, Bupleurum scorzonerifolium and Bupleurum falcatum root.

As national implementation can differ, national standards bodies can modify the values given in 5.3, 5.4,

5.5, and 5.8 in their national standards. Examples of national and regional values are given in Annex G.

© ISO 2021 – All rights reserved
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FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 23965:2021(E)
Traditional Chinese medicine — Bupleurum chinense,
Bupleurum scorzonerifolium and Bupleurum falcatum root
1 Scope

This document specifies minimum requirements and test methods for Bupleurum chinense, Bupleurum

scorzonerifolium and Bupleurum falcatum root.

This document applies to Bupleurum chinense, Bupleurum scorzonerifolium and Bupleurum falcatum root

that are sold and used as natural medicines in international trade, including Chinese materia medica

(whole medicinal materials) and decoction pieces.
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 18664, Traditional Chinese Medicine — Determination of heavy metals in herbal medicines used in

Traditional Chinese Medicine

ISO 21371, Traditional Chinese medicine — Labelling requirements of products intended for oral or topical

use

ISO 22258, Traditional Chinese medicine — Determination of pesticide residues in natural products by gas

chromatography

ISO 22590, Traditional Chinese medicine — Determination of sulfur dioxide in natural products by titration

ISO 23723, 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 terminology databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
root mass
average mass of final samples of root
Note 1 to entry: Root mass is measured in grams.
3.2
root length
largest distance from the bottom of the tap root to the stem scar
Note 1 to entry: Root length is measured in centimetres.
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ISO/FDIS 23965:2021(E)
3.3
batch
samples collected from the same particular place at the same time
3.4
sample
representative material taken from a product, or part of a product
[SOURCE: ISO 11596:2008, 2.14, modified]
3.5
final sample
sample for the test required in this document
[SOURCE: ISO 21316:2019, 3.3, modified — Note to entry removed.]
4 Description

The structures of Bupleurum chinense DC., Bupleurum scorzonerifolium Willd., Bupleurum falcatum L.

and the dried root are shown in Figure 1.
a) Plant of Bupleurum chinense DC. b) Bupleurum chinense root
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ISO/FDIS 23965:2021(E)
c) Plant of Bupleurum scorzonerifolium Willd. d) Bupleurum scorzonerifolium root
e) Plant of Bupleurum falcatum L. f) Bupleurum falcatum root
Key
1 flowering branch 5 cross-section of fruit
2 flower 6 stamen
3 inflorescence 7 sepal
4 fruit
Figure 1 — Structures of Bupleurum chinense, Bupleurum scorzonerifolium and
Bupleurum falcatum root
© ISO 2021 – All rights reserved
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ISO/FDIS 23965:2021(E)
5 Requirements
5.1 General characteristics
The following requirements shall be met before sampling:

a) Bupleurum chinense, Bupleurum scorzonerifolium and Bupleurum falcatum root materials shall be

clean and dry.

b) The presence of living insects, mouldy root and external contaminants which are visible to the

naked eye shall not be permitted.
c) The shape of the root shall be cylindrical or long and conical.

d) The root mass and the number of the residues shall be measured by electronic balance and counting.

e) The outer surface shall be light brown with intermittent longitudinal wrinkles.

5.2 Macroscopic characteristics
5.2.1 Bupleurum chinense

The whole root is cylindrical or elongated conical, branched in the lower part, 6 cm to 15 cm in length

and 0,3 cm to 0,8 cm in diameter. The upper part consists of a bulgy root crown, usually composed

of 3 to 15 stem bases as well as the fibrous remnants of the leaf bases. The outer surface is blackish-

brown or light brown, marked with longitudinal wrinkles and showing rootlet scars and lenticel-like

protuberances. The texture is hard and compact, and difficult to break. The fracture shows concentric

fibrous rings in the wood; the bark is thin, light brown or orange-brown, while the wood is whitish-

yellow.
5.2.2 Bupleurum scorzonerifolium

The whole root is thinner than that of Bupleurum chinense, elongated conical, usually unbranched or

very slightly branched in the lower part, up to 15 cm long and 0,3 cm to 0,5 cm in diameter. The root

crown bears numerous fibres from the bases of wilted leaves in a brush-like shape. The outer surface

is blackish-brown or reddish-brown and shows numerous annular striations near the root crown. The

texture is slightly soft and the root breaks easily. The fracture is even and non-fibrous.

5.2.3 Bupleurum falcatum

The whole root is a long conical or column shape, single or branched, 10 cm to 15 cm in length and

0,5 cm to 1,5 cm in diameter. The upper part is thick and the lower part thin. The apex has numerous

hairy fibres from withered leaves. The external surface is pale brown to brown with deep wrinkles.

The texture is easily broken and the fractured surface is somewhat fibrous.
5.3 Moisture
The mass fraction of moisture should not be more than 10,0 %.
5.4 Total ash
The mass fraction of ash should not be more than 9,0 %.
5.5 Acid-insoluble ash
The mass fraction of acid insoluble ash should not be more than 3,5 %.
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ISO/FDIS 23965:2021(E)
5.6 Thin-layer chromatogram (TLC) identification

The identification of marker compound, such as saikosaponin a, with TLC shall present the spots or

bands obtained from the test and reference drug solution in the same position with the same colour.

5.7 Toxic adulterants of Bupleurum longiradiatum root

The characteristic fingerprint for the toxic adulterants of Bupleurum longiradiatum root should be

determined.
5.8 Ethanol-soluble extractives
The mass fraction of ethanol-soluble extracts should not be less than 11,0 %.
5.9 Content of marker compounds

The content of marker compounds such as saikosaponin a and d shall be determined.

5.10 Heavy metals

The content of heavy metals such as arsenic, mercury, lead and cadmium shall be determined.

5.11 Pesticide residues

The content of pesticide residues such as benzene hexachloride, DDT and pentachloronitrobenzene

shall be determined.
5.12 Sulfur dioxide residues
The content of sulfur dioxide residues should be determined.
6 Sampling

Sampling of Bupleurum chinense, Bupleurum scorzonerifolium and Bupleurum falcatum root shall be

carried out in accordance with ISO 23723.
7 Test methods
7.1 Macroscopic identification

Samples of not less than 500 g are taken from each batch randomly and observed with the naked eye,

smelled and tasted.
7.2 Determination of moisture content
See Annex A for additional information.
7.3 Determination of total ash and acid-insoluble ash content
See Annex B for additional information.
...