ISO 9306:2023

Traditional Chinese medicine — Ephedra sinica, Ephedra intermedia and Ephedra equisetina herbaceous stem

This document specifies the quality and safety requirements of Ephedra herbaceous stem, which is the dried herbaceous stem of Ephedra sinica Stapf, Ephedra intermedia Schrenk et C. A. Mey. or Ephedra equisetina Bge. (Fam. Ephedraceae). This document applies to Ephedra herbaceous stem that is sold and used as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from the plant.

Médecine traditionnelle chinoise — Tige herbacée d'Ephedra sinica, d'Ephedra intermedia et d'Ephedra equisetina

General Information

• Status: Published
• Publication Date: 23-Nov-2023
• ICS: 11.120.10 - Medicaments
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249 - Traditional Chinese medicine
• Current Stage: 6060 - International Standard published
• Start Date: 24-Nov-2023
• Due Date: 24-Nov-2024
• Completion Date: 24-Nov-2023

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 9306
First edition
2023-11
Traditional Chinese medicine —
Ephedra sinica, Ephedra intermedia
and Ephedra equisetina herbaceous
stem
Reference number
© ISO 2023
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
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Description . .1
5 Requirements . 2
5.1 General characteristics . 2
5.2 Morphological features . 2
5.3 Microscopic identification . 3
5.4 Thin-layer chromatography (TLC) identification . 4
5.5 Foreign matter . 4
5.6 Moisture . 4
5.7 Total ash . 4
5.8 Heavy metals . 4
5.9 Pesticide residues . 4
5.10 Marker compounds . 4
6 Sampling . 4
7 Test methods . 4
7.1 Macroscopic identification . 4
7.2 Microscopic identification . 4
7.3 Thin-layer chromatography (TLC) identification . 4
7.4 Determination of foreign matter . 4
7.5 Determination of moisture content . 5
7.6 Determination of total ash . 5
7.7 Determination of heavy metals . 5
7.8 Determination of pesticide residues . 5
7.9 Determination of marker compounds . 5
8 Test report . 5
9 Packaging, storage and transportation . 5
10 Marking and labelling . 6
Annex A (informative) Thin-layer chromatography (TLC) identification of Ephedra
herbaceous stem . 7
Annex B (informative) Determination of marker compounds by HPLC-UV .8
Annex C (informative) Reference information regarding national and regional
requirements for Ephedra herbaceous stem .10
Annex D (informative) Reference information for Ephedra przewalskii Stapf .12
Bibliography .15
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
Ephedra herbaceous stem is a commonly used Chinese herbal medicine with a long history. It is recorded
in the classics of Chinese medicine: Treatise on Febrile Diseases, Synopsis of the Golden Chamber, Shen
[1]
Nong's Materia Medica and Compendium of Materia Medica. Its medicinal materials are derived from
the dried herbaceous stem of Ephedra sinica Stapf, Ephedra intermedia Schrenk et C. A. Mey. and Ephedra
equisetina Bge. (Fam. Ephedraceae).
Clinically, Ephedra herbaceous stem is mainly used to treat wind-cold cold, chest tightness, asthma and
cough and feng shui oedema. Modern scientific research has found many types of chemical components
of Ephedra herbaceous stem, including volatile oil, alkaloids, flavonoids and polysaccharides. Among
these, alkaloids ephedrine and pseudoephedrine have the highest content and are also the most effective
ingredients for medicinal value and drug manufacturing. Modern pharmacological studies have shown
that the methanol extract of Ephedra herbaceous stem has an anti-inflammatory effect, ephedra
decoction has the effect of anti-pathogenic microorganisms, the volatile oil in Ephedra herbaceous stem
has a sweating effect and has an inhibitory effect on influenza viruses and ephedrine has the effect of
raising blood pressure. It can excite the heart, constrict blood vessels and excite the central meridian.
Pseudoephedrine has a noticeable diuretic effect and relieves bronchial smooth muscle spasms.
Ephedra herbaceous stem is also a Chinese medicine frequently used in the Chinese medicine treatment
plan to fight COVID-19. In addition, ephedrine alkaloids are known to induce palpitation, excitation,
insomnia and dysuria as side effects. Prolonged use of Ephedra herbaceous stem can lead to addiction,
and athletes should not use it as a stimulant. Ephedrine alkaloids and products containing ephedrine
alkaloids are strictly regulated in China, Europe and the United States of America. Therefore, ion-
exchange column chromatography was investigated by Japanese researchers to prepare an ephedrine
alkaloid-free Ephedra herb extract by eliminating ephedrine alkaloids from Ephedra herb extract. The
ephedrine alkaloid-free Ephedra herb extract was reported as a safer alternative to crude Ephedra
[2]
herb with comparable analgesic, anticancer and anti-influenza activities. Furthermore, Ephedra
przewalskii Stapf. (see Annex D) is also used as Ephedra herbaceous stem in ethnic herbal medicine with
[3,4]
low ephedrine and pseudoephedrine content. The ephedrine alkaloid-free Ephedra herb extract
and Ephedra przewalskii can be considered as an alternative to Ephedra herbaceous stem in the clinical
application in some areas.
Ephedra herbaceous stem has a lot of international attention and demand, and as a special
medicinal material its quality should be strengthened and controlled at the international level.
Searching the published papers using ephedrine as the subject term in the Web of Science database
(https://www.webofscience.com/wos) for nearly a decade revealed that 57 countries and regions have
carried out relevant research, of which the top 10 countries were China, the United States of America,
India, the United Kingdom, Japan, South Africa, Germany, Turkey, France and Canada. According to
Chinese customs data, the average export trade value of medicinal Ephedra herbaceous stem from 2012
to 2016 reached US$ 3 million per year. Japan, South Korea and Taiwan are the main importers.
In terms of quality supervision of medicinal materials, the quality and safety of Ephedra herbaceous stem
[5] [6]
are regulated in the Pharmacopoeia of the People's Republic of China, the European Pharmacopoeia,
[7] [8]
the Japanese Pharmacopoeia, the Korean Pharmacopoeia and the Hong Kong Chinese Materia
[9]
Medica Standards. However, the requirements are not all the same among these pharmacopoeias and
standards. The Ephedra herbaceous stem standards have not yet been unified at the international level,
leading to the supervision being different among the regulatory authorities in many countries.
In addition, Ephedra herbaceous stem ranks second only to ginseng in ISO/TR 23975. This means
that Ephedra herbaceous stem is a high priority in ISO/TC 249 in terms of developing International
Standards.
In summary, it is essential to develop an International Standard for Ephedra herbaceous stem to
ensure its consistency of quality and safety and regulate its international trade, and also to explore the
international supervision and control of particular types of Chinese medicinal materials.
As national implementation can differ, national standards bodies are invited to modify the values given
in 5.5, 5.6 and 5.7 in their national standards. Examples of national and regional values are given in
Annex C.
v
INTERNATIONAL STANDARD ISO 9306:2023(E)
Traditional Chinese medicine — Ephedra sinica, Ephedra
intermedia and Ephedra equisetina herbaceous stem
1 Scope
This document specifies the quality and safety requirements of Ephedra herbaceous stem, which is the
dried herbaceous stem of Ephedra sinica Stapf, Ephedra intermedia Schrenk et C. A. Mey. or Ephedra
equisetina Bge. (Fam. Ephedraceae).
This document applies to Ephedra herbaceous stem that is sold and used as natural medicine in
international trade, including Chinese materia medica (whole medicinal materials) and decoction
pieces derived from the 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 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 23723:2021, 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
Ephedra herbaceous stem
dried herbaceous stem of Ephedra sinica Stapf, Ephedra intermedia Schrenk et C. A. Mey. or Ephedra
equisetina Bge
4 Description
Ephedra herbaceous stem is collected in autumn and dried in the sun (see Figure 1).
a) Plant of Ephedra sinica Stapf. b) Plant of Ephedra intermedia c) Plant of Ephedra equisetina
Schrenk et C. A. Mey. Bge.
Key
1 herbaceous stem
2 female cones
3 scaly leaf
4 woody stem
5 male cones
Figure 1 — Structure of Ephedra herbaceous stem
5 Requirements
5.1 General characteristics
The following requirements shall be met before sampling.
a) Ephedra herbaceous stem shall be clean and free of leaf and foreign matter.
b) The presence of living insects, mouldy fruit and external contaminants which are visible to the
naked eye shall not be permitted.
5.2 Morphological features
a) Ephedra sinica herbaceous stem is slender and cylindrical, infrequently branched and 1 mm to
2 mm in diameter. Some have a few brown wooden stems. Externally it is pale green. The nodes are
distinct. The internodes are 2 cm to 6 cm long. Scaly leaves are membranous on the nodes, 3 mm
to 4 mm long, with two lobes (occasionally three) and acutely triangular. The apex is greyish white
and reversed. The base is tubular and reddish-brown. The texture is light, fragile and easily broken.
The fractures are slightly fibrous with a greenish-yellow edge and subrounded reddish-brown pith.
The odour is slightly aromatic and the taste is astringent and slightly bitter.
b) Ephedra intermedia herbaceous stem is frequently branched, 1,5 mm to 3 mm in diameter and
rough. Membranous scaly leaves are 2 mm to 3 mm long, with three lobes (occasionally two). The
apex is acute. The fracture shows a triangular and rounded pith.
c) Ephedra equisetina herbaceous stem is frequently branched, 1 mm to 1,5 mm in diameter and
smooth. Internodes are 1,5 mm to 3
...