ISO 21314:2026

International
Standard
ISO 21314
Second edition
Traditional Chinese medicine —
2026-08
Salvia miltiorrhiza root and rhizome
Médecine traditionnelle chinoise — Racine et rhizome de Salvia
miltiorrhiza
Reference number
© ISO 2026
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ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Descriptions . 2
5 Requirements and recommendations . 3
5.1 General characteristics .3
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 marker compounds . .3
5.2.8 Heavy metals .4
5.2.9 Pesticide residues .4
6 Sampling . 4
7 Test methods . 4
7.1 Macroscopic identification .4
7.2 Thin-layer chromatogram(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 .5
8 Test report . 5
9 Packaging, storage and transportation . 5
10 Marking and labelling . 5
Annex A (informative) Thin-layer chromatogram(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) National and regional requirements for Salvia miltiorrhiza root and
rhizome . 14
Bibliography .15

iii
Foreword
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This document was prepared by Technical Committee ISO/TC 249, Traditional medicine, Subcommittee SC 1,
Traditional Chinese medicine.
This second edition cancels and replaces the first edition (ISO 21314:2019), which has been technically
revised.
The main changes are as follows:
— 5.2.7 and 5.2.8: combination of 5.2.7 and 5.2.8 in to a single subclause with the title “Content of compound
markers”;
— Annex E : update of the edition of the Chinese Pharmacopoeia and the Korea Pharmacopoeia;
— update of Clause 2 and Bibliography.
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
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 (Danshen) have 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 (Danshen) provided
by different cultivators is quite different, which can affect the safety and efficacy of this herb.
[1] [2] [3] [4] [5] [6]
Salvia miltiorrhiza root and rhizome (Danshen) has been recorded by , , , , and . However,
these national or regional standards are not harmonized and can be unfavourable for the international
trade of Salvia miltiorrhiza root and rhizome (Danshen) . One of the significant differences between them is
that different chemical markers, or the same chemical markers with different limitations, are used. 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 (Danshen)
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 can 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 and 5.2.7 in their national standards. Examples of national and regional
values are given in Annex E.
v
International Standard ISO 21314:2026(en)
Traditional Chinese medicine — Salvia miltiorrhiza root and
rhizome
1 Scope
This document specifies the requirements and test methods for Salvia miltiorrhiza root and rhizome, which
are derived from the Salvia miltiorrhiza Bge. plant.
It is applicable to Salvia miltiorrhiza root and rhizome that are 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 18664, Traditional Chinese Medicine — Determination of heavy metals in herbal medicines used in
Traditional Chinese Medicine
ISO 22258, Traditional Chinese medicine — Determination of pesticide residues in natural products by gas
chromatography
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
Salvia miltiorrhiza 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 (3.2) remaining after treatment with hydrochloric acid
3.4
tanshinones
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 are the dried root and rhizome of Salvia miltiorrhiza Bunge. 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
2 leaf
3 stem
4 flower (showing stamen)
5 calyx
6 rhizome
7 fibrous root
8 root
NOTE Schematic representation, not to scale.
Figure 1 — Structure of Salvia miltiorrhiza

5 Requirements and recommendations
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.
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 purp
...