ISO 23965:2022

INTERNATIONAL ISO
STANDARD 23965
First edition
2022-03
Traditional Chinese medicine —
Bupleurum chinense, Bupleurum
scorzonerifolium and Bupleurum
falcatum root
Médecine traditionnelle chinoise — Racine de Bupleurum chinense,
Bupleurum scorzonerifolium et Bupleurum falcatum
Reference number
© ISO 2022
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ii
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
Foreword
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This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
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iv
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.
v
INTERNATIONAL STANDARD ISO 23965:2022(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
...