ISO 4564:2023
(Main)Traditional Chinese medicine — Scutellaria baicalensis root
Traditional Chinese medicine — Scutellaria baicalensis root
This document specifies minimum requirements and test methods for root of Scutellaria baicalensis, which is derived from cultivated Scutellaria baicalensis Georgi. This document applies to Scutellaria baicalensis root that are sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.
Médecine traditionnelle chinoise — Racine de Scutellaria baicalensis
General Information
Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 4564
First edition
2023-05
Traditional Chinese medicine —
Scutellaria baicalensis root
Médecine traditionnelle chinoise — Racine de Scutellaria baicalensis
Reference number
© ISO 2023
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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 . 1
5 Requirements . 2
5.1 General characteristics . 2
5.2 Morphological features . 3
5.3 Microscopic identification . 3
5.3.1 Transverse section . . . 3
5.3.2 Powder . 3
5.4 Moisture . 3
5.5 Total ash . 3
5.6 Ethanol-soluble extractives . 4
5.7 Thin-layer chromatogram identification . 4
5.8 Content of marker compounds . 4
5.9 Heavy metals . 4
5.10 Pesticide residues . 4
6 Sampling . 4
7 Test methods . 4
7.1 Macroscopic identification . 4
7.2 Microscopic identification . 4
7.3 Determination of moisture content . 4
7.4 Determination of total ash content . 4
7.5 Determination of ethanol-soluble extractives . 4
7.6 Thin-layer chromatogram identification . 4
7.7 Determination of marker compounds . 4
7.8 Determination of heavy metals contents . 5
7.9 Determination of pesticide residues contents. 5
8 Test report . 5
9 Packaging, storage and transportation . 5
10 Marking and labelling . 5
Annex A (informative) Thin-layer chromatogram identification. 6
Annex B (informative) Determination of marker compounds . 8
Annex C (informative) Referenced information of national and regional requirements on
Scutellaria baicalensis root .10
Bibliography .12
iii
Foreword
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This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
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iv
Introduction
Scutellaria baicalensis is a traditional herbal medicine with the common name Baikal skullcap or
Chinese skullcap. It is a species of flowering plant of the genus Lamiaceae, widely distributed in China,
the Russian Federation, Mongolia and the Democratic People's Republic of Korea. It is one of the 50
fundamental herbs used in traditional Chinese medicine and is known as huángqín (黄芩) in Chinese.
Its root is the main medicinal part.
As a traditional Chinese herbal medicine, Scutellaria baicalensis has shown significant effects in
the treatment of various diseases and conditions, including insomnia, anxiety, stroke, fever, high
cholesterol, atherosclerosis, rabies, epilepsy, nervous tension, allergies, skin infections, inflammation
and spasms. It is also used for the treatment of hepatitis, atherosclerosis, hypertension, hyperlipidemia,
type 2 diabetes, dysentery, ulcerative colitis and respiratory disorders.
The purpose of this document is to provide systematic and comprehensive methods for the quality
control of Scutellaria baicalensis for direct medicinal and pharmaceutical use.
As national implementation can differ, national standards bodies are invited to modify the values given
in 5.4 and 5.5 in their national standards. Examples of national and regional values are given in Annex C.
v
INTERNATIONAL STANDARD ISO 4564:2023(E)
Traditional Chinese medicine — Scutellaria baicalensis
root
1 Scope
This document specifies minimum requirements and test methods for root of Scutellaria baicalensis,
which is derived from cultivated Scutellaria baicalensis Georgi.
This document applies to Scutellaria baicalensis root that are sold and used as natural medicines in
international trade, including Chinese materia medica (whole medicinal materials) 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 21371, Traditional Chinese medicine — Labelling requirements of products intended for oral or topical
use
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 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
batch
samples of no more than 5 000 kg collected from the same particular place at the same time
[SOURCE: ISO 23972:2021,3.1]
4 Descriptions
The plant and dried Scutellaria baicalensis root are shown in Figure 1.
Key
A plant of Scutellaria baicalensis C transverse section of the tap root
B dried tap root D tap root without lateral root
1 flowering branch 10 warty protruding
2 flower 11 lateral root scar
3 leaf 12 epidermis
4 stem 13 vascular cambium
5 rhizome 14 phloem
6 lateral root 15 xylem
7 tap root 16 ray
8 rootlets 17 stem scar
9 stem scar 18 root scar
Figure 1 — Structure of Scutellaria baicalensis root
5 Requirements
5.1 General characteristics
The following requirements shall be met before sampling.
a) Scutellaria baicalensis root shall be clean and free from steam, leave and foreign matter.
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