ISO 7450:2023

INTERNATIONAL ISO
STANDARD 7450
First edition
2023-10
Traditional Chinese medicine —
Pinellia ternata tuber
Médecine traditionnelle chinoise — Tubercule de Pinellia ternata
Reference number
© ISO 2023
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ii
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Description . .2
5 Quality and safety requirements and recommendations . 3
5.1 General characteristics . 3
5.2 Morphological features of the tuber . 3
5.2.1 Raw Pinellia ternata tuber . 3
5.2.2 Liquorice-limewater-processed Pinellia ternata tuber . 4
5.2.3 Ginger-alum-processed Pinellia ternata tuber . 4
5.2.4 Alum-processed Pinellia ternata tuber . 4
5.3 Microscopic characteristics . 5
5.3.1 Raw Pinellia ternata tuber . 5
5.3.2 Processed Pinellia ternata tuber . 5
5.4 Moisture . 5
5.4.1 Raw Pinellia ternata tuber . 5
5.4.2 Processed Pinellia ternata tuber . 5
5.5 Total ash . 6
5.5.1 Raw Pinellia ternata tuber . 6
5.5.2 Liquorice-limewater-processed Pinellia ternata tuber . 6
5.5.3 Ginger-alum-processed Pinellia ternata tuber . 6
5.5.4 Alum-processed Pinellia ternata tuber . 6
5.6 Water-soluble extract . 6
5.6.1 Raw Pinellia ternata tuber . 6
5.6.2 Processed Pinellia ternata tuber . 6
5.7 Thin-layer chromatogram identification . 6
5.8 Alum . . . 6
5.8.1 Ginger-alum-processed Pinellia ternata tuber . 6
5.8.2 Alum-processed Pinellia ternata tuber . 6
5.9 Heavy metals . 6
5.10 Pesticide residue . 6
5.11 Sulfur dioxide . . 6
5.12 Microbial contamination . 7
5.13 Grading information . 7
6 Sampling . 7
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 Water-soluble extractives . 7
7.5 Thin-layer chromatogram identification . 7
7.6 Determination of alum contents . 7
7.7 Determination of heavy metals contents . 7
7.8 Determination of pesticide residues contents. 7
7.9 Determination of sulfur dioxide contents . 7
7.10 Determination of microbial contamination . 7
8 Test report . 8
9 Packaging, storage and transportation . 8
iii
10 Labelling . 8
Annex A (informative) Determination of water-soluble extractives . 9
Annex B (informative) Thin-layer chromatogram identification.10
Annex C (informative) Determination of alum contents .12
Annex D (informative) Example of traditional grades information of Pinellia ternata tuber .13
Annex E (informative) Referenced values of raw and processed Pinellia ternata tuber in
different countries and regions .14
Bibliography .16
iv
Foreword
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v
Introduction
Pinellia ternata tuber, the dried tuber of Pinellia ternata (Thunb.) Breit. (Fam. Araceae), has a long
history of medicinal use in China, Japan, Korea and other Southeast Asian countries. P. ternata tuber is
commonly used for drying dampness, resolving phlegm and descending counterflow to relieve nausea
and vomiting.
Owing to its effectiveness, there has recently been an increasing demand for P. ternata tuber in China
and worldwide. According to data from Chinese customs, the average annual demand for P. ternata
tuber from 2015 to 2019 was about 1 800 tons and overseas trade counts for as much as USD 1 million
per year. P. ternata tuber is ranked no. 3 in the priority list of single herbal medicines for developing
standards (see ISO/TR 23975).
P. ternata tuber has a pungent taste with a numbing and irritating sensation in the gastrointestinal
mucosa, throat and oral cavity. Its properties are warm, pungent and toxic. Indeed, unprocessed
P. ternata tuber, or its insufficiently boiled decoction, causes acrid irritation of the oral and
laryngopharynx mucosa when taken by mistake. The toxicity and side effects of raw P. ternata tuber
can be reduced dramatically with proper processing and dose control. Three kinds of processed P.
ternata tuber with different processing methods are available and traded on the market, as well as
applied in clinical treatments: liquorice-limewater-processed P. ternata tuber, ginger-alum-processed P.
ternata tuber and alum-processed P. ternata tuber. However, a unified International Standard regarding
the characteristics of and test methods for raw and processed P. ternata tuber is not yet available.
The regulatory authorities in many countries have not adequately differentiated high-toxic forms of
P. ternata tuber from less-toxic forms (or even non-toxic forms). Additionally, the quality of raw and
processed P. ternata tuber provided from different areas varies a lot. Therefore, an International
Standard for raw and processed P. ternata tuber in terms of quality control of this herb and its products
is urgently required to ensure the safe use of these medicinal materials.
This document aims to build a systematic and practical International Standard for P. ternata tuber to
control and supervise its stable quality, to ensure its safe and effective application in clinics, to regulate
the trade in the global market and to reduce cases of Pinellia poisoning.
As national implementation can differ, national standards bodies are invited to modify the values given
in 5.4, 5.5 and 5.8 in their national standards. Examples of national and regional values are given in
Annex E.
vi
INTERNATIONAL STANDARD ISO 7450:2023(E)
Traditional Chinese medicine — Pinellia ternata tuber
1 Scope
This document specifies the quality and safety requirements and test methods of Pinellia ternata tuber,
including raw and processed Pinellia ternata tuber [dried tuber of Pinellia ternata (Thunb.) Breit.].
This document does not cover processing methods of Pinellia ternata tuber.
This document is applicable to raw and processed Pinellia ternata tuber that are sold and used as
natural medicines in international trade, including Chinese materiamedica (whole medicinal material)
and decoction pieces derived from this plant.
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/TS 21310, Traditional Chinese medicine — Microscopic examination of medicinal herbs
ISO 22217, Traditional Chinese medicine —Storage requirements for raw materials and decoction pieces
ISO 22258, Traditional Chinese medicine — Determination of pesticide residues in natural products by gas
chromatography
ISO 22467, Traditional Chinese medicine — Determination of microorganisms in natural products
ISO 22590, Traditional Chinese medicine — Determination of sulfur dioxide in natural products by titration
ISO 23723:2021, 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
raw Pinellia ternata tuber
dried tuber of Pinellia ternata (Thunb.) Breit
3.2
processed Pinellia ternata tuber
dried tuber of Pinellia ternata (Thunb.) Breit after traditional processing
Note 1 to entry: Commonly used varieties of processed Pinellia ternata tuber include liquorice-limewater-
processed Pinellia ternata tuber, ginger-alum-processed Pinellia ternata tuber and alum-processed Pinellia
ternata tuber.
3.3
liquorice-limewater-processed Pinellia ternata tuber
processed Pinellia ternata tuber in liquorice and limewater
Note 1 to entry: Liquorice-limewater-processed Pinellia ternata tuber is processed with the following method:
soak the dried raw Pinellia ternata tuber in water until the tuber is fully wet, decoct proper liquorice (Glycyrrhiza
root and rhizome) with water twice, mix the decoction solutions then pour into the limewater; add the soaked
Pinellia ternata tuber and stir it one to two times per day, maintaining a pH value over 12,0; gradually prolong t
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