ISO 19836:2025
(Main)Traditional Chinese medicine - Platycodon grandiflorus root
Traditional Chinese medicine - Platycodon grandiflorus root
This document specifies the minimum requirements and test methods for Platycodongrandiflorus root. It is applicable to Platycodon grandiflorus roots that are sold and used as natural medicines in international trade, including Chinese material medica (whole medicinal material) and decoction pieces derived from this plant.
Médecine traditionnelle chinoise — Racine de Platycodon grandiflorus
General Information
- Status
- Published
- Publication Date
- 22-Jul-2025
- Technical Committee
- ISO/TC 249 - Traditional Chinese medicine
- Drafting Committee
- ISO/TC 249 - Traditional Chinese medicine
- Current Stage
- 6060 - International Standard published
- Start Date
- 23-Jul-2025
- Due Date
- 15-Mar-2026
- Completion Date
- 23-Jul-2025
Overview
ISO 19836:2025 - Traditional Chinese medicine - Platycodon grandiflorus root establishes minimum requirements and test methods for the dried root of Platycodon grandiflorus used as natural medicine and decoction pieces in international trade. The standard covers identification, quality and safety criteria, sampling, test methods, packaging, storage and labelling for Platycodon grandiflorus root (Chinese material medica). Key SEO keywords: ISO 19836:2025, Platycodon grandiflorus root, Traditional Chinese medicine, quality and safety requirements, platycodin D.
Key topics and technical requirements
- Scope and definitions: Applies to whole medicinal material and decoction pieces of Platycodon grandiflorus root.
- Macroscopic and microscopic identification:
- Morphology: cylindrical/slightly fusiform roots, 7–20 cm length and 0.7–2.0 cm diameter.
- Colour, fracture and texture descriptions (peeled vs. unpeeled surfaces).
- Microscopic features: cork, phelloderm, laticiferous tube groups, xylem structure; powder characteristics including inulin and vessel fragment sizes.
- Quality and safety parameters:
- Moisture, total ash and acid‑insoluble ash.
- Dilute ethanol‑soluble extractives.
- Marker compound(s): determination of platycodin D content (informative annex).
- Contaminant testing: heavy metals, pesticide residues and sulfur dioxide.
- Analytical methods:
- Thin‑layer chromatography (TLC) identification.
- Microscopic examination.
- Specific test procedures for moisture, ash, extractives, platycodin D and contaminants (including referenced ISO methods).
- Operational requirements:
- Sampling, test reporting, packaging, storage, transportation, marking and labelling guidance.
Practical applications and users
ISO 19836:2025 is practical for:
- Manufacturers and processors of herbal raw materials and decoction pieces - to implement consistent quality control and product specifications.
- Analytical and quality‑control laboratories - for validated TLC, microscopy and chemical determinations (including platycodin D analysis).
- Regulators and customs authorities - to assess conformity of imported/exported Platycodon root material.
- Traders and exporters/importers - to meet international trade requirements and reduce non‑conformances.
- Pharmacopoeia committees and TCM practitioners - as a harmonized reference supporting safety and efficacy considerations.
Benefits include improved product safety, reproducible quality criteria, and facilitation of international trade in Traditional Chinese medicine ingredients.
Related standards
- ISO 18664 (heavy metals), ISO/TS 21310 (microscopic examination), ISO 21371 (labelling), ISO 22217 (storage), ISO 22258 (pesticide residues), ISO 22590 (sulfur dioxide), ISO 23723 (general TCM raw material requirements). These referenced documents support the test methods and conformity assessment outlined in ISO 19836:2025.
Frequently Asked Questions
ISO 19836:2025 is a standard published by the International Organization for Standardization (ISO). Its full title is "Traditional Chinese medicine - Platycodon grandiflorus root". This standard covers: This document specifies the minimum requirements and test methods for Platycodongrandiflorus root. It is applicable to Platycodon grandiflorus roots that are sold and used as natural medicines in international trade, including Chinese material medica (whole medicinal material) and decoction pieces derived from this plant.
This document specifies the minimum requirements and test methods for Platycodongrandiflorus root. It is applicable to Platycodon grandiflorus roots that are sold and used as natural medicines in international trade, including Chinese material medica (whole medicinal material) and decoction pieces derived from this plant.
ISO 19836:2025 is classified under the following ICS (International Classification for Standards) categories: 11.120.10 - Medicaments. The ICS classification helps identify the subject area and facilitates finding related standards.
You can purchase ISO 19836:2025 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of ISO standards.
Standards Content (Sample)
International
Standard
ISO 19836
First edition
Traditional Chinese medicine —
2025-07
Platycodon grandiflorus root
Médecine traditionnelle chinoise — Racine de Platycodon
grandiflorus
Reference number
© ISO 2025
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Description . 1
5 Quality and safety requirements and recommendations . 2
5.1 General characteristics .2
5.2 Morphological features .2
5.2.1 Appearance .2
5.2.2 Colour .3
5.2.3 Dimensions .3
5.2.4 Fracture .3
5.3 Microscopic characteristics .3
5.3.1 Transverse section .3
5.3.2 Powder .4
5.4 Thin-layer chromatogram (TLC) identification .5
5.5 Moisture .5
5.6 Total ash .5
5.7 Acid-insoluble ash .5
5.8 Dilute ethanol-soluble extract .5
5.9 Marker compound(s) .6
5.10 Heavy metals .6
5.11 Pesticide residues .6
5.12 Sulfur dioxide .6
6 Sampling . 6
7 Test methods . 6
7.1 Macroscopic identification .6
7.2 Thin-layer chromatogram (TLC) identification .6
7.3 Microscopic 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 dilute ethanol-soluble extractives .6
7.8 Determination of platycodin D .6
7.9 Determination of heavy metals .7
7.10 Determination of pesticide residues .7
7.11 Determination of sulfur dioxide .7
8 Test report . 7
9 Packaging, storage and transportation . 7
10 Marking and labelling . 7
Annex A (informative) Thin-layer chromatogram (TLC) identification . 8
Annex B (informative) Determination of dilute ethanol-soluble extractives .10
Annex C (informative) Determination of platycodin D content .11
Annex D (informative) National and regional requirements for Platycodon grandiflorus root .13
Bibliography .15
iii
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and 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 medicine, Subcommittee SC 1,
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.
iv
Introduction
Platycodon grandiflorus root, the dried root of Platycodon grandiflorus (Jacq.) A. De Candolle (Fam.
Campanulaceae), was first recorded in Shengnong Bencao in China and has a long history as a traditional
herbal medicine. It can improve the function of the lung and the pharynx and help relieve phlegm and
suppuration; it is used in the therapeutic treatment of cough, phlegm, sore throat and other pulmonary or
respiratory disorders. As a medicinal food homology species, Platycodon grandiflorus root has been used as
food and medicine for thousands of years in Asian countries, such as China, Japan and the Republic of Korea.
The quality of Platycodon grandiflorus root is crucial for its efficacy and safety. Although Platycodon
[1] [2]
grandiflorus root has been recorded in Chinese Pharmacopoeia, Japanese Pharmacopoeia, Korean
[3] [4] [5]
Pharmacopoeia, British Pharmacopoeia and European Pharmacopoeia, there have been no unique
requirements for Platycodon grandiflorus root. The establishment of an international standard for Platycodon
grandiflorus root, therefore, can help to promote international trade.
As national implementation can differ, national standards bodies can modify the value given in 5.6 in their
national standards. Examples of national and regional values are given in Annex D.
v
International Standard ISO 19836:2025(en)
Traditional Chinese medicine — Platycodon grandiflorus root
1 Scope
This document specifies the minimum requirements and test methods for Platycodongrandiflorus root.
It is applicable to Platycodon grandiflorus roots that are sold and used as natural medicines in international trade,
including Chinese material medica (whole medicinal material) and decoction pieces derived from this 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/TS 21310, Traditional Chinese medicine — Microscopic examination of medicinal herbs
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 terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
Platycodon grandiflorus root
dried root of Platycodon grandiflorus (Jacq.) A. DC.
3.2
marker compound
chemical constituent within a medicinal herb that can be used to verify its quality
4 Description
Platycodon grandiflorus root is the dried root of Platycodon grandiflorus (Jacq.) A. DC. in the family of
Campanulaceae, as shown in Figure 1.
a) Plant of Pla
...
La norme ISO 19836:2025 offre un cadre essentiel pour la certification et l'évaluation de la racine de Platycodon grandiflorus, aussi connue sous le nom de racine de bellflower. En précisant les exigences minimales et les méthodes d'essai, ce document joue un rôle crucial dans la normalisation des produits de médecine traditionnelle chinoise (MTC) sur le marché international. L'un des points forts de la norme réside dans son applicabilité. En s'adressant directement aux racines de Platycodon grandiflorus utilisées en tant que médecines naturelles, cette norme permet de garantir la qualité et la sécurité des matériaux médicinaux. La norme couvre à la fois les matériaux médicinaux entiers et les morceaux de décoction, ce qui élargit son champ d'application et assure une cohérence dans les pratiques commerciales à l'échelle mondiale. La pertinence de l'ISO 19836:2025 est accentuée par l'importance croissante de la médecine traditionnelle dans le cadre des soins de santé modernes. En fournissant des critères clairs et des méthodes de test rigoureuses, cette norme aide non seulement les producteurs à respecter des standards de qualité, mais elle offre également aux consommateurs une assurance quant à l'authenticité et à la sécurité des produits qu'ils utilisent. En résumé, l'ISO 19836:2025 se positionne comme un référentiel incontournable pour les acteurs du secteur de la médecine traditionnelle, consolidant ainsi la confiance des consommateurs et facilitant le commerce international des racines de Platycodon grandiflorus.
Die ISO 19836:2025 ist ein bedeutendes Dokument, das die minimalen Anforderungen und Testmethoden für die Wurzel des Platycodon grandiflorus spezifiziert. Dieses Dokument hat eine essentielle Relevanz innerhalb der traditionellen chinesischen Medizin, da es die Qualitätsstandards für das in internationalen Handelsströmen eingesetzte Material definiert. Der Anwendungsbereich dieser Norm umfasst sowohl die gesamten medizinischen Rohstoffe als auch die Dekoktstücke, die aus dieser Pflanze gewonnen werden. Dies gewährleistet, dass die Produkte, die auf dem Markt angeboten werden, die erforderlichen Qualitätskriterien erfüllen und somit die Sicherheit und Wirksamkeit für die Anwender garantieren. Eine der Stärken der ISO 19836:2025 liegt in ihrer detaillierten Festlegung von Testmethoden, die es ermöglichen, die Authentizität und Reinheit der Platycodon grandiflorus Wurzel objektiv zu bewerten. Die Norm schafft so einheitliche Bedingungen für die Qualitätssicherung und trägt dazu bei, dass die Konsumenten vertrauensvoll auf die Verwendung dieses Naturheilmittels zurückgreifen können. Mit der zunehmenden Globalisierung des Marktes für traditionelle chinesische Medizin wird die Relevanz der ISO 19836:2025 immer größer. Sie unterstützt nicht nur den internationalen Handel, sondern fördert auch das Verständnis und die Akzeptanz traditioneller Heilmethoden in der modernen Gesundheitsversorgung. Die Einführung solcher Standards ist entscheidend für die Integration von traditioneller und konventioneller Medizin und trägt maßgeblich dazu bei, das Vertrauen in natürliche Arzneimittel zu stärken.
ISO 19836:2025는 전통 중국 의학에서 중요한 역할을 하는 플라티코돈 그란디플로루스 뿌리에 대한 표준화 문서로, 이 문서는 플라티코돈 그란디플로루스 뿌리에 대한 최소 요구사항과 시험 방법을 규정하고 있습니다. 이 표준은 국제 무역에서 자연 약제로 판매 및 사용되는 플라티코돈 그란디플로루스 뿌리에 적용되며, 중국 전통 의약에서 사용되는 원물 및 이 식물에서 파생된 탕제로 구분됩니다. 이 표준의 강점은 명확하게 정의된 최소 요구사항으로, 품질 보증과 제품의 일관성을 도모할 수 있게 합니다. 이에 따라 제조업체와 소비자는 플라티코돈 그란디플로루스 뿌리의 신뢰성 높은 공급을 보장받을 수 있으며, 이는 전통 중국 의학의 신뢰성을 강화하는데 기여합니다. 또한, 다양한 시험 방법을 규정함으로써, 플라티코돈 그란디플로루스 뿌리의 품질을 객관적으로 평가할 수 있는 기준을 제공합니다. ISO 19836:2025는 국제 무역에서의 사용에 적합하여, 글로벌 시장에서의 플라티코돈 그란디플로루스 뿌리의 수출입을 촉진하고, 다양한 문화와 국가에서의 전통 의학에 대한 인식을 높이며, 지속 가능한 발달을 지원합니다. 따라서 이 문서는 플라티코돈 그란디플로루스 뿌리의 품질 및 안전성을 보장하는 데 필수적인 요소로 자리매김하고 있습니다.
ISO 19836:2025は、プラティコドン・グランディフロルスの根に関する国際的な標準を定めた重要な文書です。この標準は、自然薬として国際貿易において使用されるプラティコドン・グランディフロルスの根に関する最低限の要件および試験方法を明確にしています。これにより、中国薬材（全体の医薬品材料）やこの植物から派生した煎じ薬のピースに適用されることが確保されています。 ISO 19836:2025の強みは、その明確さと包括性にあります。標準は、プラティコドン・グランディフロルスの根の品質を保証するための具体的な試験方法を示しており、製品の一貫性を確保するための基準を提供しています。これにより、消費者や製造者が安心して使用できる製品が提供されることを促進します。 また、この標準は国際的な貿易の中での適用性が高く、異なる地域の規制や要件に柔軟に対応できるように設計されている点も特筆すべきです。このことは、プラティコドン・グランディフロルスの根がグローバルな市場での受け入れを促進し、異なる文化圏での伝統医学の利用を更に広げる要因となるでしょう。 さらに、ISO 19836:2025は、伝統的な中国医学におけるプラティコドン・グランディフロルスの重要性を裏付けるものであり、ここに示された基準を遵守することにより、古代からの知恵と現代の科学が融合することを示しています。この標準は、今後の研究や製品開発の基盤ともなり、持続可能な伝統医療の発展を支えます。
ISO 19836:2025 is an essential standard that outlines the minimum requirements and testing methods for Platycodon grandiflorus root, which holds significant importance in traditional Chinese medicine. The standard’s scope is comprehensive, targeting the global trade of this medicinal plant, including both whole medicinal material and decoction pieces. One of the key strengths of ISO 19836:2025 is its ability to ensure quality and consistency in the preparation and use of Platycodon grandiflorus root. With increasing globalization and the rise in demand for natural medicines, having a standardized reference helps protect both consumers and manufacturers. The guidelines provided help ensure that the medicinal properties of Platycodon grandiflorus are preserved and that products are not adulterated or misrepresented. Moreover, the detailed testing methods specified in the document enhance the credibility of the products that utilize Platycodon grandiflorus root. These methods serve as a benchmark, facilitating regulatory compliance and supporting the integrity of traditional Chinese medicine practices. As the standard caters to stakeholders in international trade, it plays a vital role in harmonizing practices across borders, fostering market access, and enabling better trade relations within the herbal medicine industry. Overall, ISO 19836:2025 is a pivotal document that reinforces the importance of quality assurance in traditional medicine, ensuring that Platycodon grandiflorus root meets established criteria for safety, efficacy, and authenticity in the global market. Its relevance and practicality contribute significantly to the advancement of traditional herbal medicines and support the overall health of consumers.
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...