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

General Information

Status
Published
Publication Date
18-Feb-2019
Current Stage
6060 - International Standard published
Start Date
14-Nov-2018
Completion Date
19-Feb-2019
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ISO 21314:2019 - Traditional Chinese medicine -- Salvia miltiorrhiza root and rhizome
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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 21314:2019(E)
ISO 2019
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ISO 21314:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

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ii © ISO 2019 – All rights reserved
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ISO 21314:2019(E)
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

© ISO 2019 – All rights reserved iii
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ISO 21314:2019(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 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
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ISO 21314:2019(E)
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.
© ISO 2019 – All rights reserved v
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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: General advice on sampling

3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
3.1
root and rhizome
underground part of Salvia miltiorrhiza
3.2
total ash
residue obtained after incineration at 525 ± 25 °C
3.3
acid-insoluble ash
part of the total ash remaining after treatment with hydrochloric acid
© ISO 2019 – All rights reserved 1
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ISO 21314:2019(E)
3.4
tanshinones

umbrella term of tanshinone IIA (C H O ), cryptotanshinone (C H O ) and tanshinone I (C H O )

19 18 3 19 20 3 18 12 3
4 Descriptions

Salvia miltiorrhiza root and rhizome is the dried root and rhizome of Salvia miltiorrhiza Bge. in the

Lamiaceae (Labiatae) family as shown in Figure 1.
a) Aerial part of Salvia miltiorrhiza plant b) Dried root and rhizome
Key
1 raceme 5 calyx
2 leaf 6 rhizome
3 stem 7 fibrous root
4 flower (showing stamen) 8 root
Figure 1 — Structure of Salvia miltiorrhiza
5 Requirements
5.1 General characteristics

The following requirements shall be met before separating the bulk sample into test samples:

a) Salvia miltiorrhiza root and rhizome shall be clean and free from foreign matter.

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ISO 21314:2019(E)

b) The presence of living insects, mouldy root and rhizome and external contaminants which are

visible to the naked eye shall not be permitted.
5.2 Salvia miltiorrhiza root and rhizome
5.2.1 Morphological features of root and rhizome
a) The rhizomes are short and stout, sometimes with a stem at the apex.

b) The roots are long, cylindrical and slightly curved. Some are branched and with rootlets.

c) The roots are 10 cm to 20 cm long, 0,3 cm to 1,5 cm in diameter.

d) The outer surface is brownish-red or dark brownish-red with rough and wrinkled longitudinal

texture. The bark of old roots is loose, mostly purplish-brown and usually fall-off.

e) The texture is hard and fragile.

f) The fracture is loose with cleft or slightly flat and compact with brownish-red cortex, greyish-

yellow or purplish-brown xylem and yellowish-white xylem rays arranged radially.
5.2.2 Thin-layer chromatogram (TLC) identification

The identification of Salvia miltiorrhiza root and rhizome by thin-layer chromatogram (TLC) shall

present spots or bands with a colour and position corresponding to those of reference solutions.

5.2.3 Moisture
The mass fraction of moisture should not be more than 13,0 %.
5.2.4 Total ash
The mass fraction of total ash should not be more than 10,0 %.
5.2.5 Acid insoluble ash limit
The mass fraction of total ash should not b
...

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