ISO 4564:2023

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

• Status: Published
• Publication Date: 21-May-2023
• ICS: 11.120.10 - Medicaments
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249/WG 1 - Quality and safety of raw materials and traditional processing
• Current Stage: 6060 - International Standard published
• Start Date: 22-May-2023
• Due Date: 02-Mar-2023
• Completion Date: 22-May-2023

Overview

ISO 4564:2023 specifies minimum requirements and test methods for the root of Scutellaria baicalensis (Baikal/Chinese skullcap) derived from cultivated Scutellaria baicalensis Georgi. The standard covers whole Chinese materia medica and decoction pieces sold and used as natural medicines in international trade. Its purpose is to provide systematic, reproducible criteria for quality control of Scutellaria baicalensis root used in Traditional Chinese Medicine (TCM) and related pharmaceutical applications.

Key topics and technical requirements

• Scope & applicability: Applies to cultivated Scutellaria baicalensis root for medicinal use (whole materials and decoction pieces).
• Description & morphology: Defines macroscopic features (size, colour, texture, fracture) and detailed morphological traits used for identification.
• Microscopic identification: Transverse section and powder characteristics (cork, phloem, xylem, starch granules) for laboratory confirmation.
• Chemical and physical limits:
  • Moisture content: ≤ 15.0% (subject to national modification).
  • Total ash: ≤ 6.0% (subject to national modification).
  • Ethanol‑soluble extractives: to be determined according to methods cited.
• Marker compounds: Quantification required for baicalin, baicalein, and wogonin; Thin-layer chromatography (TLC) identification for baicalin is specified.
• Contaminant testing:
  • Heavy metals (arsenic, mercury, lead, cadmium) - methods referenced.
  • Pesticide residues - methods referenced.
• Sampling & test methods: Sampling procedures, minimum sample sizes, and testing protocols are specified or referenced to other ISO documents.
• Quality assurance: Test report content, packaging/storage/transportation requirements, and labelling/marking guidance are included.
• Annexes: Informative annexes provide TLC identification (Annex A), marker compound determination (Annex B), and national/regional requirement examples (Annex C).

Practical applications and users

ISO 4564:2023 is intended for:

• Quality control and analytical laboratories verifying authenticity and purity of Scutellaria baicalensis root.
• Herbal product manufacturers and pharmaceutical companies producing TCM formulations and decoction pieces.
• Importers, exporters and customs authorities involved in international trade of Chinese materia medica.
• Regulatory agencies and standards bodies integrating harmonized test methods into national pharmacopoeias.
• TCM practitioners and formulary developers who require validated quality specifications.

Related standards

Normative references in ISO 4564:2023 include:

• ISO 23723 (general requirements & sampling), ISO/TS 21310 (microscopy), ISO 18664 (heavy metals), ISO 22258 (pesticide residues), ISO 22217 (storage), ISO 21371 (labelling).

Keywords: ISO 4564:2023, Scutellaria baicalensis root, Traditional Chinese Medicine, quality control, baicalin, baicalein, wogonin, TLC, heavy metals, pesticide residues, Chinese materia medica.

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
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
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Phone: [phone]
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Published in Switzerland
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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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
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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
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 late
...