ISO 24049:2025
(Main)Traditional Chinese medicine — Aconitum carmichaelii parent root tuber
Traditional Chinese medicine — Aconitum carmichaelii parent root tuber
This document specifies minimum requirements and test methods for Aconitum carmichaelii parent root tuber. This document applies to Aconitum carmichaelii parent root tuber that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant. Processing methods and processed products of Aconitum carmichaelii parent root tuber are excluded.
Médecine traditionnelle chinoise — Tubercule parent d'Aconitum carmichaelii
General Information
Standards Content (Sample)
International
Standard
ISO 24049
First edition
Traditional Chinese medicine —
2025-10
Aconitum carmichaelii parent
root tuber
Médecine traditionnelle chinoise — Tubercule parent d'Aconitum
carmichaelii
Reference number
© ISO 2025
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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 . 2
5.1 General characteristics .2
5.2 Morphological features of root tuber .3
5.3 Microscopic identification .3
5.3.1 Transverse section . . .3
5.3.2 Powder .3
5.4 Thin-layer chromatography identification .4
5.5 Moisture .4
5.6 Total ash .4
5.7 Acid-insoluble ash .4
5.8 Marker compounds .4
5.9 Heavy metals .4
5.10 Pesticide residues .4
6 Sampling . 5
7 Test methods . 5
7.1 Macroscopic identification .5
7.2 Microscopic identification .5
7.3 Thin-layer chromatography identification .5
7.4 Determination of moisture .5
7.5 Determination of total ash .5
7.6 Determination of acid-insoluble ash .5
7.7 Determination of marker compounds .5
7.8 Determination of heavy metal .5
7.9 Determination of pesticide residues .5
8 Test report . 5
9 Packaging, storage and transportation . 6
10 Marking and labelling . 6
Annex A (informative) Thin-layer chromatography identification . 7
Annex B (informative) Reference information of national and regional requirements for
Aconitum carmichaelii parent root tuber . 8
Bibliography .10
iii
Foreword
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Traditional Chinese medicine.
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iv
Introduction
Aconitum carmichaelii parent root tuber (Aconiti Radix, Chuanwu) is the dried parent root of Aconitum
carmichaelii Debx in the Ranunculaceae family. It is a high-value and an important source of medicinal herb
with characteristic analgesic and anti-inflammatory activities. It is first-mentioned in Shen Nong Ben Cao
Jing and widely used in China, Korea and other countries for a long history.
Modern pharmacological studies show that Aconitum carmichaelii parent root tuber has good therapeutic
effects on inflammation, pain, tumours, immune diseases and cardiovascular diseases. The chemical
composition of Aconitum carmichaelii parent root tuber is complex, mainly containing diterpenoid alkaloids,
polysaccharide, volatile oil, flavonoids and saponins. At present, aconitine-type diterpenoid alkaloids are the
main characteristic compounds and principal pharmacological ingredients of Aconitum carmichaelii parent
root tuber. Therefore, aconitine, mesaconitine, and hypaconitine are used as the marker compounds of
[2]
Aconitum carmichaelii parent root tuber in Chinese Pharmacopoeia and Hong Kong Standard for Chinese
[9]
Medicinal Materials .
It's well known for its clinical benefits, as well as its high toxicity. The toxic components of Aconitum
carmichaelii parent root tuber are also its active components. The high toxicity risk and narrow therapeutic
range limit the medicinal application on a larger scale. Diester alkaloids such as aconitine and hypaconitine
have cardiovascular toxicity, nervous-system toxicity and digestive-system toxicity. In recent years, a few
phenomena appeared in the market for aconite products: fake and inferior goods flood the market; many
products are not processed in accordance with the traditional process, increasing the risk related to drug
safety. These not only affect the market environment, but also the safety of clinical medication.
At present, Aconitum carmichaelii parent root tuber and related products are restricted in international
trade by many countries because of the risk of toxic ingredients. Aconitine poisoning caused by improper
use has been reported from time to time. There are various causes of aconite poisoning, including overdoses,
inadequate processing, aconitum contamination in other herbs, and dispensing errors. What’s more, hidden
toxic Aconitum alkaloids, such as yunaconitine, crassicauline A and 8-deacetyl-yunaconitine, were detected
instead of aconitine, hypaconitine, and mesaconitine in the urine samples of the aconitum poisoning patients
in Hong Kong. These hidden toxic Aconitum alkaloids have been found in commonly used Aconitum herbs,
including Aconitum carmichaelii parent root tuber. Therefore, these alkaloids also should be included in the
quality and safety control standards for Aconitum herbs.
However, the standards for Aconitum carmichaelii parent root tuber are not yet harmonized at an
international level and regulatory authorities in many nations do not adequately differentiate highly toxic
forms from less-toxic forms (or even non-toxic forms) of Aconitum carmichaelii parent root tuber. Effectively
controlling and supervising the quality and safety of this medicinal material and expanding its international
market requires more accurate quality control and standardized procedures at every stage.
Therefore, an International Standard is required for the quality control of Aconitum carmichaelii parent
root tuber and related products to ensure the safe use of these medical materials. The establishment of an
International Standard
...
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