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Title: Draft BS ISO 13615 Traditional Chinese Medicine - Atractylodes macrocephala rhizome.

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Introduction
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 DRAFT INTERNATIONAL STANDARD
ISO/DIS 13615

ISO/TC 249 Secretariat: SAC

Voting begins on: Voting terminates on:
2023-09-07 2023-11-30

Traditional Chinese Medicine — Atractylodes

macrocephala rhizome

ICS: 11.120.10

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FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY This document is circulated as received from the committee secretariat.
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
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ISO/DIS 13615:2023(E)
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NOTIFICATION OF ANY RELEVANT PATENT
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PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023
ISO/DIS 13615:2023(E)

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© ISO 2023
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ii  © ISO 2023 – All rights reserved


 ISO/DIS 13615:2023(E)

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.................................................................................................................................................................... 3
5.2.1 Atractylodes macrocephala rhizome................................................................................................................... 3
5.2.2 Decoction pieces.................................................................................................................................................................. 3
5.3 Identification............................................................................................................................................................................................. 3
5.3.1 Thin-layer chromatography (TLC) identification.................................................................................. 3
5.3.2 High performance liquid chromatography (HPLC) identification.......................................... 3
5.4 Moisture........................................................................................................................................................................................................ 3
5.5 Total ash........................................................................................................................................................................................................ 3
5.6 Sulfur dioxide residues..................................................................................................................................................................... 3
5.7 Ethanol-soluble extractives......................................................................................................................................................... 4
5.8 Essential oil................................................................................................................................................................................................ 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 Thin-layer chromatography (TLC) identification.................................................................................................... 4
7.3 High performance liquid chromatography (HPLC) identification............................................................ 4
7.4 Determination of moisture content...................................................................................................................................... 4
7.5 Determination of total ash content....................................................................................................................................... 4
7.6 Determination of sulfur dioxide residues content................................................................................................... 4
7.7 Determination of ethanol-soluble extractives content........................................................................................ 4
7.8 Determination of essential oil content............................................................................................................................... 5
7.9 Determination of heavy metals content........................................................................................................................... 5
7.10 Determination of pesticide residues content............................................................................................................... 5
8 Test report................................................................................................................................................................................................................... 5
9 Packaging, storage and transportation....................................................................................................................................... 5
10 Marking and labelling..................................................................................................................................................................................... 5
Annex A (informative) Thin-layer chromatography (TLC) identification................................................................... 6
Annex B (informative) High performance liquid chromatography (HPLC) identification........................ 8
Annex C (informative) Reference values of national and regional limits of moisture, total
ash, ethanol-soluble extractives, atractylenolide III, sulfur dioxide residues, heavy
metals and pesticide residues in Atractylodes macrocephala rhizome................................................... 11
Bibliography..............................................................................................................................................................................................................................12

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ISO/DIS 13615:2023(E)

Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
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
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
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expressions related to conformity assessment, as well as information about ISO's adherence to
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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.

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 ISO/DIS 13615:2023(E)

Introduction
Atractylodes macrocephala rhizome, the dried rhizome of Atractylodes macrocephala Koidz., is a widely
used herbal medicine in China and many other countries. In traditional Chinese medicine, this herb can
tonify the Spleen-Qi, and is used to treat distension in the abdomen, loose stools, and diarrhea. Modern
pharmacological studies also demonstrate its great potential in immuno-enhancement and indigestion
treatment. The market, yield, and trade volume of Atractylodes macrocephala is large, and develop
rapidly in recent years.
Atractylodes macrocephala has been recorded in several pharmacopoeias, including Chinese
Pharmacopoeia, European Pharmacopoeia, Japanese Pharmacopoeia, Korean Pharmacopoeia, British
Pharmacopoeia and Hong Kong Chinese Materia Medical Standards. The requirements and specifications
in these standards have differences. Therefore, it is important to develop an international standard for
harmonizing the existing standards, as well as ensuring the safety and effectiveness of Atractylodes
macrocephala, which will benefit farmers, consumers, enterprises and governments involved in the
cultivation, regulation and trade of Atractylodes macrocephala.
As national implementation may 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.

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DRAFT INTERNATIONAL STANDARD ISO/DIS 13615:2023(E)

Traditional Chinese Medicine — Atractylodes

macrocephala rhizome

1 Scope
This document specifies minimum requirements and test methods for Atractylodes macrocephala
rhizome that is derived from Atractylodes macrocephala Koidz.
It is applicable to Atractylodes macrocephala rhizome that is sold and used as a 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 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 22590, Traditional Chinese medicine — Determination of sulfur dioxide in natural products by titration
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 terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://​w ww​.iso​.org/​obp
— IEC Electropedia: available at https://​w ww​.electropedia​.org/​
3.1
Atractylodes macrocephala rhizome
dried rhizome of Atractylodes macrocephala Koidz.
3.2
rhizome
the main stem of a plant that sends out roots and shoots from its nodes, also called creeping rootstalks

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ISO/DIS 13615:2023(E)

4 Descriptions
Atractylodes macrocephala rhizome is dried rhizome of Atractylodes macrocephala Koidz. in the family
of Atractylodes, as shown in Figure 1. The crude drug is collected in winter while the leaf at the lower
part of the plant turns yellow and the leaf at the upper part becomes fragile, removed from soil, baked
or sunned to dryness, and then removed from fibrous root.

Key
A plant of Atractylodes macrocephala
B dried rhizome of Atractylodes macrocephala
C decoction pieces of Atractylodes macrocephala
1 flower
2 foliage
3 wrinkles and grooves
4 warty protrudings
5 dotted oil cavities
6 chrysanthemum-shaped cracks

Figure 1 — Structure of Atractylodes macrocephala

5 Requirements and recommendations

5.1 General characteristics

The following requirements shall be met before sampling.
a) Atractylodes macrocephala rhizome shall be clean and free from foreign matter.
b) The presence of living insects, moulds and external contaminants which are visible to the naked
eye shall not be permitted.

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 ISO/DIS 13615:2023(E)

5.2 Morphological features

5.2.1 Atractylodes macrocephala rhizome

a) Irregularly plump masses, frog, drumstick or ruyi-shaped, 3 cm to 13 cm long and 1,5 cm to 7 cm in

diameter.
b) Externally greyish yellow or greyish brown, with warty protrudings, interrupted longitudinal
wrinkles and grooves, and scars of fibrous rootlets; remains of stems and bud scars attached to the
apex.
c) Texture hard, not easily broken, fracture uneven, yellowish-white to pale brown, scattered with
obvious brownish-yellow dotted oil cavities. The bake-dried material horny and relatively dark
coloured or cracked in section view.
d) Odour, aromatic; taste sweet and slightly pungent, viscous on chewing.

5.2.2 Decoction pieces

a) Irregular thick slices.

b) Externally greyish yellow or greyish brown.
c) Cut surface yellowish-white to pale brown, scattered with obvious brownish-yellow dotted oil
cavities, xylem with radial striations; cut surface horny and with deeper colour and clefts when
drying by oven.
d) Odour faint aromatic; taste sweet and slightly pungent, somewhat viscous on chewing.

5.3 Identification

5.3.1 Thin-layer chromatography (TLC) identification

The identification of Atractylodes macrocephala rhizome by thin-layer chromatogram (TLC) should

present spots or bands with the same colour and positions corresponding to those of the reference
standard solution and the test solution. Furthermore, other faint zones may be present in the
chromatogram obtained with the test solution.

5.3.2 High performance liquid chromatography (HPLC) identification

When TLC bands are not clearly identified, HPLC identification can be applied. The chromatogram of
the test solution exhibits 3 characteristic peaks (atractylenolide II, atractylenolide III and atractylon),
corresponding in the retention times to those in chromatogram of the reference standard solution.

5.4 Moisture
The moisture content should not be more than 15,0 %.

5.5 Total ash

The total ash content should not be more than 7,0 %.

5.6 Sulfur dioxide residues

The content of sulfur dioxide residues should be determined.

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ISO/DIS 13615:2023(E)

5.7 Ethanol-soluble extractives

The ethanol-soluble extractives content should be determined.

5.8 Essential oil

The essential oil content should be determined.

5.9 Heavy metals

The contents of heavy metals such as arsenic, cadmium, lead and mercury shall be determined.

5.10 Pesticide residues

The contents of pesticide residues such as hexachlorocyclohexane (BHC), dichloro-diphenyl-
trichloroethane (DDT) and quintozene shall be determined.

6 Sampling
Sampling of Atractylodes macrocephala rhizome shall be in accordance with ISO 23723.

7 Test methods

7.1 Macroscopic identification

Samples not less than 500 g are taken from each batch randomly. These samples are examined by the
naked eye, smell and taste.

7.2 Thin-layer chromatography (TLC) identification

See Annex A for additional information on thin-layer chromatography (TLC) identification.

7.3 High performance liquid chromatography (HPLC) identification

See Annex B for additional information on high performance liquid chromatography (HPLC)
identification.

7.4 Determination of moisture content

The testing method specified in ISO 23723 shall apply.

7.5 Determination of total ash content

The testing method specified in ISO 23723 shall apply.

7.6 Determination of sulfur dioxide residues content

The testing method specified in ISO 22590 shall apply.

7.7 Determination of ethanol-soluble extractives content

The testing methods specified in ISO 23723 shall apply.

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 ISO/DIS 13615:2023(E)

7.8 Determination of essential oil content

The testing method specified in ISO 23723 shall apply.

7.9 Determination of heavy metals content

The testing method specified in ISO 18664 shall apply.

7.10 Determination of pesticide residues content

The testing method specified in ISO 22258 shall apply.

8 Test report
For each test method, the test report shall specify the following:
a) all information necessary for the complete identification of the sample;
b) the sampling method used;
c) the test method(s) used;
d) the test result(s) obtained;
e) all operating details not specified in this document, or regarded as optional, together with details
of any incidents which may have influenced the test result(s);
f) any unusual features (anomalies) observed during the test;
g) the date of the test.

9 Packaging, storage and transportation

The packaging shall not transmit any flavour or odour to the product and shall not contain substances
which may damage the product or constitute a health risk.
The method specified in ISO 22217 shall apply for the storage of Atractylodes macrocephala rhizome.
The product shall be protected from light, moisture, pollution and foreign substances during long
distance delivery.

10 Marking and labelling

The requirements specified in ISO 21371 shall apply. The following items shall be marked or labelled on
the packages:
a) product name and plant scientific name;
b) all quality features indicated in Clause 5;
c) country and province/state of the products;
d) date of production, batch number and expiry date of the products;
e) items required by the regulatory body of the destination country.

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ISO/DIS 13615:2023(E)

Annex A
(informative)

Thin-layer chromatography (TLC) identification

A.1 Preparation of test solution

Weigh approximately 1,0 g of the powder (through an 80 mesh or finer sieve), add 2 ml of methanol,
ultrasonic extract for 15 min, filter, take filtrate as the test solution.

A.2 Preparation of reference solution

Weigh the appropriate amount of atractylenolide II, add methanol to make the reference solution at a
concentration of 0,1 mg/ml.

A.3 Developing solvent system

Prepare a mixture of cyclohexane and 2-propanol in the volume ratio of 9:1 as the mobile phase.

A.4 Procedure
Use silica gel as the adsorbent for the thin-layer plate. Apply separately to the plate 3 μl of thetest
solution and the reference standard solution. Use the mobile phase as the developing agent, unfold, take
out, dry, spray with 10 % sulfuric acid in ethanol, and heat for 1 min. Immediately examine under UV
light at 365 nm. Typical TLC chromatograms are shown in Figure A.1.

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 ISO/DIS 13615:2023(E)

Figure A.1 — Schematic diagram of typical TLC chromatograms of Atractylodes macrocephala

rhizome

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ISO/DIS 13615:2023(E)

Annex B
(informative)

High performance liquid chromatography (HPLC) identification

B.1 Preparation of test solution

Weigh accurately 2 g of the powder (through an 80 mesh or finer sieve), add 10 ml of methanol, let
stand for two hours, then ultrasonic extract for 30 min, centrifuge at 4 000 rpm for 10 min. Take the
supernatant and transfer it to a 50 ml volumetric flask, repeat the extraction twice, and combine the
extracts, add methanol to the mark, shake well. Before injection, pass through a filter having a 0,45-
μm pore size, and discard the first portion of the filtrate, and take the subsequent filtrate as the test
solution.

B.2 Preparation of reference standard solution

Accurately weigh a quantity of atractylenolide III to a measuring flask, dissolve in methanol to prepare
a solution containing 0,1 mg per ml as the reference standard solution.

B.3 Apparatus and chromatographic conditions

B.3.1 Column:

Stationary phase: octadecylsilyl silica gel for chromatography (5 μm).

Size: l = 250 mm, Ø = 4,6 mm.

B.3.2 Detector: UV 220 nm.

B.3.3 Flow rate: 1,0 ml/min.

B.3.4 Injection volume: 5 μl.

B.3.5 Mobile phase

B.3.5.1 Mobile phase A: acetonitrile.

B.3.5.2 Mobile phase B: water.

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 ISO/DIS 13615:2023(E)

B.3.5.3 Gradient program as shown in Table B.1.

Table B.1 — Gradient program

Time (min) Mobile phase A (%) Mobile phase B (%)
0 20 80
5 20 80
10 60 40
25 90 10
30 90 10
32 100 0
40 100 0
Note: There was no significant effect of column temperature in the range of 20 to 30 °C, injection volume in the
range of 5 to 10 μl, flow rate in the range of 0,8 to 1,2 ml/min and detection wavelength in the range of 215 to
225 nm by durability examination.

B.4 Detection of atractylenolide II, atractylenolide III and atractylon

Inject 5 μl of the reference standard solution and the test solution for chromatographic analysis,
respectively. The approximate relative retention times, relative to atractylenolide III, are provided in
Table B.2 to identify the peak of atractylenolide II and atractylon.

Table B.2 — Relative retention time and correction factor of atractylenolide II, atractylenolide
III and atractylon
Tested ingredients Relative retention time Correction factor ( f )
atractylenolide III 1,00 1,00
atractylenolide II 1,21 0,67
Atractylon 1,83 1,54

Separately calculate the percentage of atractylenolide II, atractylenolide III and atractylon in the
sample. The content is calculated with Formula (B.1):
Ax × C s × 50 1
W ( %) = f × × × 100 (B.1)
As × 103 ms × (1 − w M )
where

f is the correction factor;

A X is the peak area of the compound in the test solution;

AS is the peak area of atractylenolide III in the reference standard solution;

CS is the concentration of atractylenolide III in the reference standard solution;

mS is the mass of the sample;

wM is the moisture content of the sample (%);

W is the content of atractylenolide II, atractylenolide III or atractylon (%) in the sample.

B.5 Typical HPLC chromatograms

Typical HPLC chromatograms of Atractylodes macrocephala rhizome are shown in Figure B.1.

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ISO/DIS 13615:2023(E)

Key
A reference standard solution
B test solution
1 atractylenolide III
2 atractylenolide II
3 atractylon

Figure B.1 — Typical HPLC chromatograms of Atractylodes macrocephala rhizome

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 ISO/DIS 13615:2023(E)

Annex C
(informative)

Reference values of national and regional limits of moisture, total

ash, ethanol-soluble extractives, atractylenolide III, sulfur dioxide
residues, heavy metals and pesticide residues in Atractylodes
macrocephala rhizome

Different countries and regions give their own limits of moisture, total ash, ethanol-soluble extractives,
atractylenolide III, sulfur dioxide residues, and heavy metal in Atractylodes macrocephala rhizome.
Table C.1 show these limits of Atractylodes macrocephala rhizome stipulated by different countries and
regions.

Table C.1 — Limits of moisture, total ash, ethanol-soluble extractives, atractylenolide III,sulfur
dioxide residues, heavy metals and pesticide residues in Atractylodes macrocephala rhizome
stipulated by different countries and regions
Chinese Hong Kong
European British Phar- Korean Japanese
Authority Regu- Pharmaco- Chinese Ma-
Pharmaco- macopoeia Pharmaco- Pharmaco-
lation poeia 2020 teria Medical
poeia 10.0 2021 poeia 12 poeia 18
edition Standards
Moisture ≤ 15,0 % ≤ 14,0 % ≤ 100 ml/kg ≤ 100 ml/kg — —a
Total ash ≤ 5,0 % ≤ 5,5 % ≤ 5,0 % ≤ 5,0 % ≤ 7,0 % ≤ 7,0 %
Acid-insoluble
— ≤ 0,5 % ≤ 1,0 % ≤ 1,0 % ≤ 1,0 % ≤ 1,0 %
ash
Ethanol-soluble
≥ 35,0 % ≥ 21,0 % — — — —
extractives
Water-soluble
— ≥ 60,0 % — — — —
extractives
Essential oil
— — ≥ 9 ml/kg ≥ 9 ml/kg ≥ 0,5 ml/50 g ≥ 0,5 ml/50 g
content
atractylenolide
— ≥ 0,019 % — — — —
III
sulfur dioxide
≤ 400 mg/ml ≤ 400 mg/ml — — ≤ 30 ppm —
residues
Arsenic ≤ 2 mg/kg ≤ 2,0 mg/kg; — — ≤ 3 ppm ≤ 5 ppm
Heavy Cadmium ≤ 1 mg/kg ≤ 1,0 mg/kg ≤ 1,0 mg/kg ≤ 1,0 mg/kg ≤ 0,7 ppm
metals Lead ≤ 5 mg/kg ≤ 5,0 mg/kg ≤ 5,0 mg/kg ≤ 5,0 mg/kg ≤ 5 ppm ≤ 20 ppmb
Mercury ≤ 0,2 mg/kg ≤ 0,2 mg/kg ≤ 0,1 mg/kg ≤ 0,1 mg/kg ≤ 0,2 ppm
Pes- BHC ≤ 0,1 mg/kg ≤ 0,3 mg/kg ≤ 0,3 mg/kg ≤ 0,3 mg/kg ≤ 0,2 ppm —
ticide DDT ≤ 0,1 mg/kg ≤ 1,0 mg/kg ≤ 1 mg/kg ≤ 1 mg/kg ≤ 0,1 ppm —
resi- Quinto-
dues — ≤ 1,0 mg/kg ≤ 1 mg/kg ≤ 1 mg/kg — —
zene
a —   means the index is not set in the pharmacopoeia.
b —   means the heavy metals are the metallic inclusions that are darkened with sodium sulfide Test Solution in acidic
solution, as their quantity is expressed in terms of the quantity of lead (Pb), not more than 20 ppm.

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ISO/DIS 13615:2023(E)

Bibliography

[1] ISO 690, Information and documentation — Guidelines for bibliographic references and citations to
information resources
[2] ISO/IEC/TR 10000-1, Information technology — Framework and taxonomy of International
Standardized Profiles — Part 1: General principles and documentation framework
[3] ISO 10241-1, Terminological entries in standards — Part 1: General requirements and examples of
presentation
[4] China Pharmacopoeia Commission Pharmacopoeia of the People's Republic of China (2020, Part 1).
Beijing: Chinese medicines and Technology Press, 2020
[5] European pharmacopoeia committee. European Pharmacopoeia (10th Edition). Strasbourg:
European Directorate for the Quality of Medicines & Health Care, 2019European Pharmacopoeia,
10.0, Atractylodis macrocephalae rhizome
[6] Japanese pharmacopoeia committee. The Japanese Pharmacopoeia ( 18th ed). Tokyo: Ministry of
Health, Labour and Welfare, 2021
[7] Ministry of Food and Drug Safety The Korean Pharmacopoeia (12ed ed). Chungcheong Bukdo:
The Ministry Food and Drug Safety, 2020
[8] British Pharmacopoeia Commission British Pharmacopoeia (2021). London: Medicines and
Healthcare products Regulatory Agency, 2021
[9] CHINESE HONG KONG MATERIA MEDICA STANDARDS (HKCMMS) OFFICE, Chinese Hong Kong
Chinese Materia Medica Standards. Hong Kong: Department of Health, Hong Kong Special
Administrative Region, The People’s Republic of China, Vol. 3. 2005

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