ISO/FDIS 22586

Traditional Chinese medicine -- Paeonia lactiflora root -- White peony root

Titre manque

General Information

• Status: Published
• ICS: 11.120.10 - Medicaments
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249/WG 1 - Quality and safety of raw materials and traditional processing
• Current Stage: 5020 - FDIS ballot initiated: 2 months. Proof sent to secretariat
• Start Date: 16-Dec-2021
• Completion Date: 16-Dec-2021

Standards Content (sample)

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 22586
ISO/TC 249
Traditional Chinese medicine —
Secretariat: SAC
Paeonia lactiflora root — White peony
Voting begins on:
2021-12-16 root
Voting terminates on:
2022-02-10
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 22586:2021(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. © ISO 2021
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ISO/FDIS 22586:2021(E)
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All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

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© ISO 2021 – All rights reserved
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ISO/FDIS 22586:2021(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction .................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ..................................................................................................................................................................................... 1

3 Terms and definitions .................................................................................................................................................................................... 1

4 Descriptions .............................................................................................................................................................................................................. 2

5 Requirements .......................................................................................................................................................................................................... 2

5.1 Morphological features ................................................................................................................................................................... 2

5.1.1 Appearance ............................................................................................................................................................................. 2

5.1.2 Colour ........................................................................................................................................................................................... 3

5.1.3 Dimension ................................................................................................................................................................................. 3

5.1.4 Fracture ...................................................................................................................................................................................... 3

5.1.5 Odour ............................................................................................................................................................................................ 3

5.1.6 Taste .............................................................................................................................................................................................. 3

5.2 Microscopical characteristics ................................................................................................................................................... 3

5.3 Moisture ....................................................................................................................................................................................................... 4

5.4 Total ash ....................................................................................................................................................................................................... 4

5.5 Acid-insoluble ash ................................................................................................................................................................................ 4

5.6 Thin-layer chromatogram (TLC) identification ........................................................................................................ 4

5.7 Content of marker compounds ................................................................................................................................................. 4

5.8 Heavy metals ............................................................................................................................................................................................ 5

5.9 Pesticide residues ................................................................................................................................................................................ 5

5.10 Sulfur dioxide residues ......... .................................................................................................................................. ......................... 5

6 Sampling ....................................................................................................................................................................................................................... 5

7 Test methods ............................................................................................................................................................................................................ 5

7.1 Macroscopic identification ........................................................................................................................................................... 5

7.2 Determination of moisture content ..................................................................................................................................... 5

7.3 Determination of total ash content ...................................................................................................................................... 5

7.4 Determination of acid-insoluble ash content ............................................................................................................... 5

7.5 Thin-layer chromatogram (TLC) identification ........................................................................................................ 5

7.6 Determination of paeoniflorin content ............................................................................................................................. 5

7.7 Determination of heavy metal content ............................................................................................................................. 5

7.8 Determination of pesticide residue content ................................................................................................................. 5

7.9 Determination of sulfur dioxide residue content .................................................................................................... 5

8 Test report .................................................................................................................................................................................................................. 6

9 Packaging, storage and transportation ...................................................................................................................................... 6

10 Marking and labelling .................................................................................................................................................................................... 6

Annex A (informative) Thin-layer chromatogram (TLC) identification ........................................................................ 7

Annex B (informative) Determination of paeoniflorin content .............................................................................................. 9

Annex C (informative) Reference values of Paeonia lactiflora root in different countries

and regions..............................................................................................................................................................................................................11

Bibliography .............................................................................................................................................................................................................................13

iii
© ISO 2021 – All rights reserved
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ISO/FDIS 22586:2021(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

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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).

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expressions related to conformity assessment, as well as information about ISO's adherence to

the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see

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.
© ISO 2021 – All rights reserved
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ISO/FDIS 22586:2021(E)
Introduction

Paeonia lactiflora root, dried root of Paeonia lactiflora Pallas (Fam. Paeoniaceae), has a long history of

use in East Asian countries. There are two kinds of peony root: white peony root and red peony root,

which are used for different therapeutic purposes. White peony root is used to tonify the blood and

preserve the yin, to nourish the liver and assist in the smooth flow of qi, and to regulate the meridians

and ease pain.

White peony root is known as clinically effective for the treatment of blood deficiency and sallow

complexion, menstrual irregularities, spontaneous sweating, night sweating and chronic pain. Different

quality requirements between different countries and regions, different packaging, transportation and

storage conditions can affect the quality of white peony root.

Therefore, the harmonization of requirements of white peony root is required to ensure quality and

safety. As national implementation can differ, national standards bodies can modify the values given

in 5.3, 5.4, and 5.7 in their national standards. Examples of national and regional values are given in

Annex C.
© ISO 2021 – All rights reserved
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FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 22586:2021(E)
Traditional Chinese medicine — Paeonia lactiflora root —
White peony root
1 Scope

This document specifies the minimum requirements and test methods for white peony root derived

from the plant of Paeonia lactiflora Pallas.

It is applicable to white peony root that is sold as Chinese material medica (whole medicinal materials)

and decoction pieces derived from this plant.
It is not applicable to red peony root.
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 1577, Tea — Determination of acid-insoluble ash

ISO 18664, Traditional Chinese Medicine — Determination of heavy metals in herbal medicines used in

Traditional Chinese Medicine
ISO 20409, Traditional Chinese medicine — Panax notoginseng root and rhizome

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 23723:2021, Traditional Chinese medicine — General requirements for he
...