ISO 21314:2019
(Main)Traditional Chinese medicine — Salvia miltiorrhiza root and rhizome
Traditional Chinese medicine — Salvia miltiorrhiza root and rhizome
This document specifies the minimum requirements and test methods for Salvia miltiorrhiza root and rhizome, which is derived from the Salvia miltiorrhiza Bge. plant. It is applicable to Salvia miltiorrhiza root and rhizome that is sold and used as a natural medicine in international trade, including unprocessed and traditionally processed materials.
Médecine traditionnelle chinoise — Racine et rhizome de Salvia miltiorrhiza
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INTERNATIONAL ISO
STANDARD 21314
First edition
2019-02
Traditional Chinese medicine — Salvia
miltiorrhiza root and rhizome
Médecine traditionnelle chinoise — Racine et rhizome de Salvia
miltiorrhiza
Reference number
©
ISO 2019
© ISO 2019
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.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Descriptions . 2
5 Requirements . 2
5.1 General characteristics . 2
5.2 Salvia miltiorrhiza root and rhizome . 3
5.2.1 Morphological features of root and rhizome . 3
5.2.2 Thin-layer chromatogram (TLC) identification . . 3
5.2.3 Moisture . 3
5.2.4 Total ash . 3
5.2.5 Acid insoluble ash limit . 3
5.2.6 Extractives . 3
5.2.7 Content of tanshinones. 3
5.2.8 Content of salvianolic acid B . 3
5.2.9 Heavy metals . 4
5.2.10 Pesticide residues . 4
6 Sampling . 4
7 Test methods . 4
7.1 Macroscopic identification . 4
7.2 TLC identification . 4
7.3 Determination of moisture content . 4
7.4 Determination of total ash . 4
7.5 Determination of acid-insoluble ash . 4
7.6 Determination of extractives . 4
7.7 Determination of tanshinones . 4
7.8 Determination of salvianolic acid B . 4
7.9 Determination of heavy metals . 4
7.10 Determination of pesticide residues . 4
8 Test report . 5
9 Packaging, storage and transportation . 5
10 Marking and labelling . 5
Annex A (informative) TLC identification. 6
Annex B (informative) Determination of extractives . 8
Annex C (informative) Determination of tanshinones . 9
Annex D (informative) Determination of salvianolic acid B .12
Annex E (informative) Information on requirements of Salvia miltiorrhiza root and
rhizome in different countries and regions .14
Bibliography .16
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 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.
iv © ISO 2019 – All rights reserved
Introduction
Salvia miltiorrhiza Bge. is a perennial herbal plant in the Lamiaceae family. The root and rhizome of
this plant have been used as traditional Chinese medicines for more than 2 500 years. Used as raw
material, Salvia miltiorrhiza root and rhizome has been developed into various kinds of herbal medicine
products and used in at least 19 countries or regions for their therapeutic value and market potential
in the treatment of cardiovascular diseases, neurasthenic insomnia, liver fibrosis and cancer. It has also
been used as an ingredient in health supplements and cosmetics.
Salvia miltiorrhiza Bge. is mainly grown and cultivated in China, but is also cultivated in the USA,
Germany, Great Britain and Australia. However, the quality of Salvia miltiorrhiza root and rhizome
provided by different cultivators is quite different, which may affect the safety and efficacy of this herb.
Salvia miltiorrhiza root and rhizome has been recorded by the United States of America Pharmacopoeia,
the European Pharmacopoeia, the British Pharmacopoeia, the Chinese Pharmacopoeia, the Hong Kong
Chinese Materia Medica Standard and the Taiwan Chinese Materia Medica Standard. However, these
national or regional standards are not harmonized and may be unfavourable for the international trade
of Salvia miltiorrhiza root and rhizome. One of the significant differences between them is that different
chemical markers, or the same chemical markers with different limitations, are used in multiple
standards. These chemical markers provide a vital index for judging the quality of Salvia miltiorrhiza
root and rhizome. Therefore, the establishment of an international standard for Salvia miltiorrhiza root
and rhizome is important for the international trade of this herb and also for ensuring the consistent
quality and safety of this herb in clinical use.
As national implementation may differ, National Standards Bodies are invited to modify the values
given in 5.2.3, 5.2.4, 5.2.5, 5.2.6.1, 5.2.6.2, 5.2.7 and 5.2.8 in their national standards. Examples of
national and regional values are given in Annex E.
INTERNATIONAL STANDARD ISO 21314:2019(E)
Traditional Chinese medicine — Salvia miltiorrhiza root
and rhizome
1 Scope
This document specifies the minimum requirements and test methods for Salvia miltiorrhiza root and
rhizome, which is derived from the Salvia miltiorrhiza Bge plant.
It is applicable to Salvia miltiorrhiza root and rhizome that is sold and used as a natural medicine in
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 928, Spices and condiments — Determination of total ash
ISO 930, Spices and condiments — 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
CODEX STAN 229-1993: Analysis of pesticide residues: Recommended methods
CAC/MRL01-2009: Maximum Residue Limits for Pesticides in Foods
World Health Organization. Quality control methods for herbal materials
...
INTERNATIONAL ISO
STANDARD 21314
First edition
2019-02
Traditional Chinese medicine — Salvia
miltiorrhiza root and rhizome
Médecine traditionnelle chinoise — Racine et rhizome de Salvia
miltiorrhiza
Reference number
©
ISO 2019
© ISO 2019
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.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Descriptions . 2
5 Requirements . 2
5.1 General characteristics . 2
5.2 Salvia miltiorrhiza root and rhizome . 3
5.2.1 Morphological features of root and rhizome . 3
5.2.2 Thin-layer chromatogram (TLC) identification . . 3
5.2.3 Moisture . 3
5.2.4 Total ash . 3
5.2.5 Acid insoluble ash limit . 3
5.2.6 Extractives . 3
5.2.7 Content of tanshinones. 3
5.2.8 Content of salvianolic acid B . 3
5.2.9 Heavy metals . 4
5.2.10 Pesticide residues . 4
6 Sampling . 4
7 Test methods . 4
7.1 Macroscopic identification . 4
7.2 TLC identification . 4
7.3 Determination of moisture content . 4
7.4 Determination of total ash . 4
7.5 Determination of acid-insoluble ash . 4
7.6 Determination of extractives . 4
7.7 Determination of tanshinones . 4
7.8 Determination of salvianolic acid B . 4
7.9 Determination of heavy metals . 4
7.10 Determination of pesticide residues . 4
8 Test report . 5
9 Packaging, storage and transportation . 5
10 Marking and labelling . 5
Annex A (informative) TLC identification. 6
Annex B (informative) Determination of extractives . 8
Annex C (informative) Determination of tanshinones . 9
Annex D (informative) Determination of salvianolic acid B .12
Annex E (informative) Information on requirements of Salvia miltiorrhiza root and
rhizome in different countries and regions .14
Bibliography .16
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 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.
iv © ISO 2019 – All rights reserved
Introduction
Salvia miltiorrhiza Bge. is a perennial herbal plant in the Lamiaceae family. The root and rhizome of
this plant have been used as traditional Chinese medicines for more than 2 500 years. Used as raw
material, Salvia miltiorrhiza root and rhizome has been developed into various kinds of herbal medicine
products and used in at least 19 countries or regions for their therapeutic value and market potential
in the treatment of cardiovascular diseases, neurasthenic insomnia, liver fibrosis and cancer. It has also
been used as an ingredient in health supplements and cosmetics.
Salvia miltiorrhiza Bge. is mainly grown and cultivated in China, but is also cultivated in the USA,
Germany, Great Britain and Australia. However, the quality of Salvia miltiorrhiza root and rhizome
provided by different cultivators is quite different, which may affect the safety and efficacy of this herb.
Salvia miltiorrhiza root and rhizome has been recorded by the United States of America Pharmacopoeia,
the European Pharmacopoeia, the British Pharmacopoeia, the Chinese Pharmacopoeia, the Hong Kong
Chinese Materia Medica Standard and the Taiwan Chinese Materia Medica Standard. However, these
national or regional standards are not harmonized and may be unfavourable for the international trade
of Salvia miltiorrhiza root and rhizome. One of the significant differences between them is that different
chemical markers, or the same chemical markers with different limitations, are used in multiple
standards. These chemical markers provide a vital index for judging the quality of Salvia miltiorrhiza
root and rhizome. Therefore, the establishment of an international standard for Salvia miltiorrhiza root
and rhizome is important for the international trade of this herb and also for ensuring the consistent
quality and safety of this herb in clinical use.
As national implementation may differ, National Standards Bodies are invited to modify the values
given in 5.2.3, 5.2.4, 5.2.5, 5.2.6.1, 5.2.6.2, 5.2.7 and 5.2.8 in their national standards. Examples of
national and regional values are given in Annex E.
INTERNATIONAL STANDARD ISO 21314:2019(E)
Traditional Chinese medicine — Salvia miltiorrhiza root
and rhizome
1 Scope
This document specifies the minimum requirements and test methods for Salvia miltiorrhiza root and
rhizome, which is derived from the Salvia miltiorrhiza Bge plant.
It is applicable to Salvia miltiorrhiza root and rhizome that is sold and used as a natural medicine in
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 928, Spices and condiments — Determination of total ash
ISO 930, Spices and condiments — 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
CODEX STAN 229-1993: Analysis of pesticide residues: Recommended methods
CAC/MRL01-2009: Maximum Residue Limits for Pesticides in Foods
World Health Organization. Quality control methods for herbal materials
...
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