ISO 20759:2023 伝統的な中国医学 | ページ 2

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 Chinese medicine.

This second edition cancels and replaces the first edition (ISO 20759:2017), of which it constitutes a minor revision. The changes are as follows:

• 3.6, cross-reference to 7.7 corrected to 7.6;
• Clause 10 g) removed to comply with updated drafting rules;
• Annex D, edition dates of the Chinese Pharmacopoeia and the Taiwan Herbal Pharmacopoeia updated; all data from the Japanese Pharmacopoeia removed due to difference of the original plant of mugwort leaf;
• minor editorial changes.

Introduction

Mugwort leaf is a traditional herbal medicine. It is mainly used for the treatment of irregular menstruation, infertility, hematemesis, epistaxis, metrorrhagia and pruritus in China and some other countries. It is also the raw material for the famous moxibustion therapy, many pharmaceutical preparations and healthcare products. Mugwort leaf originates from the three species of plants Artemisia argyi Lévl. et Vant., Artemisia princeps Pampanini and Artemisia montana Pampanini. The three original species mainly grow in China and Korea, and the second and third species also grow in Japan. Among them, the dried leaf of Artemisia argyi Lévl. et Vant. has been used most extensively worldwide. This document was developed mainly to control the quality of Artemisia argyi leaf for direct medicinal and pharmaceutical purposes.

For reference, the limit values of the relevant target substance and moisture, total ash and acid-insoluble ash have been provided in Annex D. In addition, factors affecting the quality of Artemisia argyi leaf include pH and organic matters of soil, light, harvest time, as well as cultivation techniques. These factors cannot be controlled by sample analysis. Therefore, relevant information is described in Annex E as a reference.

1 Scope

This document specifies the minimum requirements and test methods of Artemisia argyi leaf for medicinal use. It is suitable for identification and quality control of this herbal medicine.

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.

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:

Bibliography