ISO 5228:2023
(Main)Traditional Chinese medicine — Rheum palmatum, Rheum tanguticum and Rheum officinale root and rhizome
Traditional Chinese medicine — Rheum palmatum, Rheum tanguticum and Rheum officinale root and rhizome
This document specifies the quality and safety requirements of Rheum root and rhizome (the dried root and rhizome of Rheum palmatum Linne., Rheum tanguticum Maxim. ex Balf. and Rheum officinale Baill.). This document applies to Rheum root and rhizome that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from these plants. This document does not apply to the processing methods and processed products of Rheum root and rhizome.
Titre manque
General Information
Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 5228
First edition
2023-07
Traditional Chinese medicine —
Rheum palmatum, Rheum tanguticum
and Rheum officinale root and rhizome
Reference number
© ISO 2023
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Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Description . .2
5 Requirements . 4
5.1 General characteristics . 4
5.2 Morphological features . 4
5.3 Identification . 4
5.3.1 Microscopic identification . . 4
5.3.2 Thin-layer chromatography (TLC) identification . 5
5.4 Rhaponticin . 5
5.5 Moisture . 5
5.6 Total ash . 5
5.7 Acid-insoluble ash . 6
5.8 Extractives . 6
5.9 Heavy metals . 6
5.10 Pesticide residues . 6
5.11 Marker compounds . 6
6 Sampling . 6
7 Test methods . 6
7.1 Macroscopic identification . 6
7.2 Thin-layer chromatogram (TLC) identification . 6
7.3 Rhaponticin identification . 6
7.4 Determination of moisture . 6
7.5 Determination of total ash . 6
7.6 Determination of acid-insoluble ash . 6
7.7 Determination of extractives . 7
7.8 Determination of heavy metals . 7
7.9 Determination of pesticide residues . 7
7.10 Determination of marker compounds . 7
8 Test report . 7
9 Packaging, storage and transportation . 7
10 Marking and labelling . 7
Annex A (informative) Thin-layer chromatography (TLC) identification .9
Annex B (informative) Determination of marker compounds by HPLC-UV .10
Annex C (informative) National and regional requirements for Rheum root and rhizome .17
Annex D (informative) Differentiation of the three species .19
Bibliography .21
iii
Foreword
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Introduction
Rheum root and rhizome is the dry root and rhizome of Rheum palmatum Linne., Rheum tanguticum
Maxim. ex Balf. and Rheum officinale Baill. As one of the four traditional Chinese medicines in China,
Rheum root and rhizome is documented in Shennong materia medica. Rheum root and rhizome has
a wide range of clinical applications, high frequency of use and a long history of medicinal use. It is
recorded in traditional Chinese medicine books such as Yao pin hua yi, Yi xue zhong zhong can xi lu and
Su Wen.
Rheum root and rhizome has a complex chemical composition, including various compounds such as
anthraquinone, anthrone, tannin and polysaccharide. Modern pharmacological studies have shown that
sennoside and anthraquinone glucosides are the main components of Rheum root and rhizome that can
induce diarrhoea; free anthraquinones are antibacterial and antitumour active ingredients of Rheum
root and rhizome; n-butyrophenones have good anti-inflammatory and analgesic effects; gallic acid
glucosides and galloyl proanthocyanidins in the tannins have hypolipidemic effects; and d-catechin
and gallic acid have haemostatic effects. Moreover, Rheum root and rhizome also has the functions
of relieving phlegm, protecting the liver and gallbladder, and protecting against cardiovascular and
cerebrovascular diseases.
In global trade, taking Chinese customs data as an example, Rheum root and rhizome in China is mainly
exported to Japan, the Republic of Korea, the United States, Indonesia, Germany, Italy, Singapore,
France, Thailand, Vietnam and Malaysia. From 2012 to 2016, the average annual export trade volume
of Rheum root and rhizome in China was 7 128 400 US dollars, making it one of the main Chinese herbal
medicines exported by China.
There are 152 Chinese patent medicines containing Rheum root and rhizome in the Chinese
Pharmacopoeia (2015 Edition) and two preparations in Japanese Pharmacopoeia (17th Edition).
Rheum root and rhizome and its products have applications in a variety of medical fields, also involving
detoxification and beauty, lipid-lowering, weight-loss health products and food additives. Many
users believe that Chinese medicine is non-toxic and fail to take it strictly according to their doctor's
instructions, which can lead to excessive and chronic irregular use of Rheum root and rhizome and liver
and kidney damage.
As a globally used drug, Rheum root and rhizome is included in the pharmacopoeia of many countries
and regions, such as China, Japan, the Republic of Korea and Europe. At present, the quality control
of Rheum root and rhizome and its preparations is mostly based on the content of anthraquinones.
However, the medicinal ingredients of Rheum root and rhizome are not just anthraquinones. The
diversity of ingredients in traditional Chinese medicine determines that quality control should adopt a
multi-index quality evaluation model.
Furthermore, Rheum root and rhizome is ranked tenth in the priority list of single herbal medicines for
developing standards in ISO/TR 23975, which indicates its high priority. Therefore, it is necessary to
establish an International Standard of Rheum root and rhizome which unifies the quality and safety of
Rheum root and rhizome, ensures the safety and effectiveness of the medication and regulates trade in
the international market. The establishment of an International Standard for Rheum root and rhizome
is necessary to guarantee the clinical effectiveness, safety and controllability of this valuable m
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