ISO 7450

Traditional Chinese medicine — Pinellia ternata tuber

Médecine traditionnelle chinoise — Tubercule de Pinellia ternata

General Information

• Status: Not Published
• ICS: 11.120.10 - Medicaments
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249 - Traditional Chinese medicine
• Current Stage: 6000 - International Standard under publication
• Completion Date: 12-Sep-2023

Standards Content (Sample)

ISO/TC 249
Date: 2023-03-28
ISO/FDIS 7450:2023(E)
ISO/TC 249
Secretariat: SAC
Traditional Chinese medicine — Pinellia ternata tuber

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Copyright notice
ThisDate: 2023-07-03

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ISO/FDIS 7450:2023(E)
© ISO document is a working draft2023
All rights reserved. Unless otherwise specified, or committee draft and is copyright-protected by ISO.
While required in the reproductioncontext of working drafts or committee drafts in any form for use
by participants in the ISO standards development process is permitted without prior permission
from ISO, neither its implementation, no part of this document nor any extract from itpublication may
be reproduced, stored or utilized otherwise in any form or transmitted in any form for any other
purposeby any means, electronic or mechanical, including photocopying, or posting on the internet or an
intranet, without prior written permission from ISO. Permission can be requested from either ISO at the
address below or ISO's member body in the country of the requester.
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CP 401 • CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
Email: [e-mail]
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it should be addressed as shown below or to ISO's member body in the country of the requester:
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Reproduction for sales purposes may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.

Published in Switzerland.
iv © ISO 2023 – All rights reserved

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ISO/FDIS 7450:2023(E)
Contents Page
Foreword . 7
Introduction . 8
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Description . 2
5 Quality and safety requirements and recommendations . 4
5.1 General characteristics . 4
5.2 Morphological features of the tuber . 4
5.2.1 Raw Pinellia ternata tuber . 4
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 Microscopical characteristics . 5
5.3.1 Raw Pinellia ternata tuber . 5
5.3.2 Processed Pinellia ternata tuber . 6
5.4 Moisture . 7
5.4.1 Raw Pinellia ternata tuber . 7
5.4.2 Processed Pinellia ternata tuber . 7
5.5 Total ash . 7
5.5.1 Raw Pinellia ternata tuber . 7
5.5.2 Liquorice-limewater-processed Pinellia ternata tuber . 7
5.5.3 Ginger-alum-processed Pinellia ternata tuber . 7
5.5.4 Alum-processed Pinellia ternata tuber . 7
5.6 Water-soluble extract . 7
5.6.1 Raw Pinellia ternata tuber . 7
5.6.2 Processed Pinellia ternata tuber . 7
5.7 Thin-layer chromatogram identification . 7
5.8 Alum . 7
5.8.1 Ginger-alum-processed Pinellia ternata tuber . 7
5.8.2 Alum-processed Pinellia ternata tuber . 7
5.9 Heavy metal . 7
5.10 Pesticide residue . 7
5.11 Sulfur dioxide . 8
5.12 Microbial contamination . 8
5.13 Grading information . 8
6 Sampling . 8
7 Test methods . 8
7.1 Macroscopic identification . 8
7.2 Determination of moisture content . 8
7.3 Determination of total ash content . 8
7.4 Water-soluble extractives. 8
7.5 Thin-layer chromatogram identification . 8
7.6 Determination of alum contents . 8
7.7 Determination of heavy metals contents . 8
7.8 Determination of pesticide residues contents . 8
7.9 Determination of sulfur dioxide contents . 8
© ISO 2023 – All rights reserved v

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ISO/FDIS 7450:2023(E)
7.10 Determination of microbial contamination . 8
8 Test report . 9
9 Packaging, storage and transportation . 9
10 Labelling . 9
Annex A (informative) Determination of water-soluble extractives . 10
Annex B (informative) Thin-layer chromatogram identification . 11
Annex C (informative) Determination of alum contents . 13
Annex D (informative) Example of traditional grades information of Pinellia ternata tuber
. 14
Annex E (informative) Referenced values of raw and processed Pinellia ternata tuber in
different countries and regions . 15
Bibliography . 17
vi © ISO 2023 – All rights reserved

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ISO/FDIS 7450:2023(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 non-governmental, 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 documentsdocument 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 drawnISO draws attention to the possibility that some of the elementsimplementation of this
document may beinvolve the subjectuse of (a) patent(s). ISO takes no position concerning the evidence,
validity or applicability of any claimed patent rights in respect thereof. As of the date of publication of
this document, ISO had not received notice of (a) patent(s) which may be required to implement this
document. However, implementers are cautioned that this may not represent the latest information,
which may be obtained from the patent database available at www.iso.org/patents. 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 ).
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.
© ISO 2023 – All rights reserved vii

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ISO/FDIS 7450:2023(E)
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 ChinaChinese 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 ofregarding 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.
viii © ISO 2023 – All rights reserved

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FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 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 are excluded.
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
materiamedicamateria 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
© ISO 2023 – All rights reserved 1

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ISO/FDIS 7450:2023(E)
processed Pinellia ternata tuber
dried tuber of Pinellia ternata (Thunb.) Breit after traditional processing
Note 1 to entry: Commonly used varieties 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 the time for
processing until the colour of the longitudinal section becomes evenly yellow and tasting it leaves the tongue slightly
numb; take it out then wash and dry it in the shade or an oven.
Note 2 to entry: The mass ratio of raw Pinellia ternata tuber, liquorice and quicklime powder is 20:3:2.
3.4
ginger-alum-processed Pinellia ternata tuber
processed Pinellia ternata tuber in ginger and alum
Note 1 to entry: Ginger-alum-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 then remove; decoct ginger slices to prepare the
ginger solution; add raw Pinellia ternata tuber and alum to boil thoroug
...

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 7450
ISO/TC 249
Traditional Chinese medicine —
Secretariat: SAC
Pinellia ternata tuber
Voting begins on:
2023-07-17
Voting terminates on:
2023-09-11
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 7450:2023(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 2023

---------------------- Page: 1 ----------------------
ISO/FDIS 7450:2023(E)
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 7450
ISO/TC 249
Traditional Chinese medicine —
Secretariat: SAC
Pinellia ternata tuber
Voting begins on:
Voting terminates on:
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
ISO copyright office
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
CP 401 • Ch. de Blandonnet 8
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
CH-1214 Vernier, Geneva
DOCUMENTATION.
Phone: [phone]
IN ADDITION TO THEIR EVALUATION AS
Reference number
Email: [e-mail]
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/FDIS 7450:2023(E)
Website: www.iso.org
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
Published in Switzerland
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN­
DARDS TO WHICH REFERENCE MAY BE MADE IN
ii
  © ISO 2023 – All rights reserved
NATIONAL REGULATIONS. © ISO 2023

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ISO/FDIS 7450:2023(E)
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 Ginger­alum­processed Pinellia ternata tuber . 4
5.2.4 Alum­processed Pinellia ternata tuber . 4
5.3 Microscopical 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 Ginger­alum­processed Pinellia ternata tuber . 6
5.5.4 Alum­processed 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 Ginger­alum­processed Pinellia ternata tuber . 6
5.8.2 Alum­processed Pinellia ternata tuber . 6
5.9 Heavy metal . 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
© ISO 2023 – All rights reserved

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ISO/FDIS 7450:2023(E)
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
  © ISO 2023 – All rights reserved

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ISO/FDIS 7450:2023(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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use
of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed
patent rights in respect thereof. As of the date of publication of this document, ISO had not received
notice of (a) patent(s) which may be required to implement this document. However, implementers are
cautioned that this may not represent the latest information, which may be obtained from the patent
database available at www.iso.org/patents. ISO shall not be held responsible for identifying any or all
such patent rights.
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.
v
© ISO 2023 – All rights reserved

---------------------- Page: 5 ----------------------
ISO/FDIS 7450:2023(E)
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, ginger­alum­processed P.
ternata tuber and alum­processed 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
  © ISO 2023 – All rights reserved

---------------------- Page: 6 ----------------------
FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 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 include liquorice-limewater-processed Pinellia ternata tuber, ginger­
alum­processed Pinellia ternata tuber and alum­processed Pinellia ternata tuber.
1
© ISO 2023 – All rights reserved

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ISO/FDIS 7
...