ISO 23962:2021

INTERNATIONAL ISO
STANDARD 23962
First edition
2021-07
Traditional Chinese medicine —
Processed Aconitum carmichaelii
lateral root
Reference number
©
ISO 2021
© ISO 2021
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ii © ISO 2021 – All rights reserved

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Descriptions . 2
5 Requirements . 3
5.1 Morphological features of root . 3
5.1.1 Salted Aconitum carmichaelii lateral root . 3
5.1.2 Black slice of Aconitum carmichaelii lateral root . 3
5.1.3 White slice of Aconitum carmichaelii lateral root . 4
5.1.4 Boiled slice of Aconitum carmichaelii lateral root . 4
5.2 Moisture . 4
5.3 Total ash . 4
5.4 Thin-layer chromatogram (TLC) identification . 4
5.5 Marker compounds . 4
5.6 Heavy metals . 4
5.7 Pesticide residues . 5
6 Sampling . 5
7 Test methods . 5
7.1 Macroscopic identification . 5
7.2 Determination of moisture content . 6
7.3 Determination of total ash content. 6
7.4 Thin-layer chromatogram (TLC) identification . 6
7.5 Determination of marker compounds . 6
7.6 Determination of heavy metal content. 6
7.7 Determination of pesticide residue content . 6
7.8 Roots number/1000 g . 6
8 Test report . 6
9 Packaging, storage and transportation . 6
10 Marking and labelling . 7
Annex A (informative) Determination of moisture content . 8
Annex B (informative) Thin-layer chromatogram (TLC) identification . 9
Annex C (informative) Reference information of national and regional requirements for
processed Aconitum carmichaelii lateral root .11
Annex D (informative) Reference information of commercial grading requirements for
Aconitum carmichaelii lateral root .15
Bibliography .16
Foreword
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iv © ISO 2021 – All rights reserved

Introduction
Processed Aconitum carmichaelii lateral root (Aconiti Lateralis Radix, Fuzi, 附子) has been used as a
herbal medicine in traditional Chinese medicine for a very long time. It remains a highly valued herb
today because of its significant effects. Aconitum carmichaelii lateral root is one of the most frequently
used herbal medicines in traditional Chinese medicine. Of an approximate total of 80 0000 traditional
Chinese medicine formulas, around 7,04 % of formulations include Aconitum carmichaelii lateral root
[1]
as an ingredient. Among 113 formulas in the Treatise on Cold Pathogenic Diseases (伤寒论), one of four
great classics of traditional Chinese medicine, there are 23 formulations with Aconitum carmichaelii
lateral root (occupying 20,35 %) as an ingredient. Among 202 formulas in the Synopsis of Golden
[2]
Chamber (金匮要略), another of the four great classics of traditional Chinese medicine, there are 26
prescriptions with Aconitum carmichaelii lateral root as an ingredient (12,87 %). Among 148 Kampo
medicines for prescription from the Ministry of Health, Labour and Welfare (MHLW) of Japan, there are
10 prescriptions with Aconitum carmichaelii lateral root as an ingredient (6,76 %).
Processed Aconitum carmichaelii lateral root contains aconitum alkaloids which have anti-inflammatory,
analgesic and cardiotonic activities. These aconitum alkaloids are irreplaceably effective for injuries,
arthritis, neuropathic pain, sequelae of apoplexy, stomach pain, stomach crymodynia, menoxenia,
abscesses, deep-rooted carbuncles and sores. Aconitum alkaloids are, however, a double-edged sword.
At present, international trade in processed Aconitum carmichaelii lateral root is restricted in a number
of nations due to the high natural toxicity of processed Aconitum carmichaelii lateral root. Also, there
are sporadic cases of aconitum alkaloid poisoning reported worldwide due to misuse.
Nonetheless, the toxicity of processed Aconitum carmichaelii lateral root can be reduced dramatically
with proper processing (such as repeated boiling or steaming), prolonged decocting and dose control.
However, standards for processed Aconitum carmichaelii lateral root 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 lateral root.
The six aconite alkaloids [Aconitine (AC), mesaconitine (MA), hypaconitine (HA), benzoylaconine
(BAC), benzoylmesaconine (BMA) and benzoylhypaconine (BHA)] are commonly used as chemical
[3]
markers for quality control of processed Aconitum carmichaelii lateral root. AC, MA and HA are toxic
diester diterpenoid alkaloids, while BAC, BMA and BHA are active monoester diterpenoid alkaloids.
To guarantee safety, efficacy and quality, these six alkaloids are commonly controlled in different
pharmacopoeia. Nevertheless, poisoning cases are still occasionally reported. From 1989 to 2010, 140
[4]
cases of aconitum poisoning, including one fatal case, were reported in Hong Kong. Additionally,
17 cases were reported in Taiwan from 1990 to 1999, 2017 cases were reported in China from 1989
[5]
to 2008 and 121 cases were reported in Korea from 1995 to 2007. Multiple reasons for aconitum
poisoning exist, include overdoses, inadequate processing, aconitum contamination in other herbs,
dispensing and management errors, and hidden risk factors. In the 17 cases reported in Hong Kong,
yunaconitine (YAC), crassicauline A (CCA) and 8-deacetyl-yunaconitine (DYA) were detected instead
[4,6]
of AC, MA and HA in the urine samples of the aconitum poisoning patients. Because YAC, DYA and
CCA were detected in the urine of the aconitum poisoning patients, these alkaloids are considered to be
[6]
hidden risk factors and should be covered in laboratory screenings for toxic compounds. Therefore,
an International Standard is required for Aconitum carmichaelii lateral root for quality control of the
[5]
herb and its products and to ensure the safe use of these medical materials .
This document provides a systematic and practical International Standard for Aconitum carmichaelii
lateral root to control and guarantee stable quality, to ensure safe and effective use in clinics, to
standardize the global market trade and to reduce cases of aconite poisoning.
As national implementation can differ, national standards bodies are invited to modify the values given
in 5.2, 5.3 and 5.5 in their national standards. Examples of national and regional values are given in
Annex C.
INTERNATIONAL STANDARD ISO 23962:2021(E)
Traditional Chinese medicine — Processed Aconitum
carmichaelii lateral root
1 Scope
This document specifies minimum requirements and test methods for processed Aconitum carmichaelii
lateral root (lateral root of Aconitum carmichaelii Debx.).
This document applies to processed Aconitum carmichaelii lateral root 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 of Aconitum carmichaelii lateral root are
excluded.
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 1575, Tea — Determination of total ash
ISO 18664, Traditional Chinese Medicine — Determination of heavy metals in herbal medicines used in
Traditional Chinese Medicine
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 23191, Traditional Chinese medicine — Determination of selected Aconitum alkaloids by high-
performance liquid chromatography (HPLC)
World Health Organization Quality control methods for herbal materials, 2011
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
fresh Aconitum carmichaelii lateral root
fresh lateral root of Aconitum carmichaelii Debx. with the tap root, rootlet and soil removed
3.2
Aconitum carmichaelii lateral root
unprocessed dried lateral root of Aconitum carmichaelii Debx.
3.3
processed Aconitum carmichaelii lateral root
dried lateral root of Aconitum carmichaelii Debx. after processing
Note 1 to entry: This includes commercial varieties such as salted Aconitum carmichaelii lateral root, black slice
of Aconitum carmichaelii lateral root and white slice of Aconitum carmichaelii lateral root.
3.4
salted Aconitum carmichaelii lateral root
processed Aconitum carmichaelii lateral root in bittern
Note 1 to entry: The decoction pieces are processed with the following method: select the large and uniform
fresh Aconitum carmichaelii lateral root; wash clean and soak overnight in bittern, of which the main ingredient is
edible calcium chloride solution; add salt, soak and take out to sun-dry and air-dry every day; gradually prolong
the drying time until a lot of salt is crystallized on the surface of the drug and its texture becomes hard.
Note 2 to entry: Bittern is liquid residue of mineral salt, the major constituent being magnesium chloride.
3.5
black slice of Aconitum carmichaelii lateral root
processed Aconitum carmichaelii lateral root in bittern with dye
Note 1 to entry: The decoction pieces are processed with the following method: select the large and uniform
fresh Aconitum carmichaelii lateral root; wash clean and soak in bittern for several days; boil in the infusion
thoroughly; take out, rinse in water, cut longitudinally into slices about 0,5 cm in thickness; soak and rinse in
water once again; stain the slices dark brown (e.g. with black bean decoction, strong tea water) and steam them
until they turn oily and lustrous; bake the slices to half-dryness, then sun-dry or bake to complete dryness.
3.6
white slice of Aconitum carmichaelii lateral root
processed Aconitum carmichaelii lateral root in bittern without bark
Note 1 to entry: The decoction pieces are processed with the following method: select the large and uniform
fresh Aconitum carmichaelii lateral root; wash clean and soak in bittern for several days; boil in the infusion
thoroughly; take out, peel the bark and cut longitudinally into slices about 0,3 cm in thickness; soak and rinse in
water, take out, steam thoroughly, sun-dry to dryness.
3.7
boiled slice of Aconitum carmichaelii lateral root
processed Aconitum carmichaelii lateral root with salt, Glycyrrhizae root and black beans
Note 1 to entry: The decoction pieces are processed with the following method: blanch salted Aconitum
carmichaelii lateral root with water two or three times a day until all the salt is rinsed out; boil together with
Glycyrrhizae root, black beans and water until the centre of the cut surface is devoid of white core and the cut
slice is numb to the tongue; remove Glycyrrhizae root and black beans, cut the drug into slices and dry.
3.8
batch
samples collected from the same particular place at the same time, of no more than 5 000 kg
4 Descriptions
Processed Aconitum carmichaelii lateral root is derived from the dried lateral root of Aconitum
carmichaelii Debx. (Family Ranunculaceae) after processing (Figure 1).
2 © ISO 2021 – All rights reserved

Key
A plant of Aconitum carmichaelii Debx. 1 flower
B main root of Aconitum carmichaelii Debx. 2 leaf
C lateral root of Aconitum carmichaelii Debx. 3 stem
D unprocessed Aconitum carmichaelii lateral root 4 rootlet
E black slice of Aconitum carmichaelii lateral root 5 depressed bud scar
6 tubercled short rootlet
7 longitudinal vascular bundles
Figure 1 — Structure of Aconitum carmichaelii lateral root
5 Requirements
5.1 Morphological features of root
5.1.1
...