ISO 7177:2023 伝統的な漢方薬 — オウレンとオウレンの根茎 | 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.

Introduction

Coptis rhizome is used as traditional Chinese medicine in China. The rhizome of Coptis japonica Makino. is also used as herbal medicine in Japan and the Republic of Korea. As one of the most commonly used medicinal herbs, Coptis rhizome was listed in Shennong materia Medica. Treatise on Febrile diseases contains 113 prescriptions, including 12 containing Coptis rhizome.

However, there are still some concerns about the quality control of Coptis rhizome, outlined as follows, which affect the trade and use of this herb.

• a) The harvesting and processing methods and techniques have not been standardized. Issues such as low efficiency, large interference from human factors and poor controllability seriously affect the quality of Coptis rhizome materials.
• b) Even though many countries or regions, such as China, Japan, the Republic of Korea and Europe, have established pharmacopoeia standards for Coptis rhizome, the relevant requirements vary significantly, which limits the application of those standards in global trade.
• c) The lack of quality standards for certain processed products, such as Coptis rhizome products processed with wine, ginger or Euodia fruit, makes it difficult to control their quality. This can affect the efficacy and safety of these products.

Coptis rhizome is ranked the fourth in the priority list of single herbal medicines for developing standards in ISO/TR 23975:2019. Thus, it is essential to develop an International Standard for Coptis rhizome to ensure consistency in the quality of Coptis rhizome and safe use of this herb and also to promote international trade.

In this document, the identification of commonly adulterated species of Coptis rhizome is also introduced.

As national implementation can differ, national standards bodies are invited to modify the values given in 5.5, 5.6 and 5.7 based on their national standards. Examples of national values are given in Annex C.

1 Scope

This document specifies the minimum requirements and test methods for Coptis rhizome (the dried rhizome of Coptis chinensis Franch. and Coptis japonica Makino.).

This document applies to Coptis rhizome sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from these plants.

This document does not apply to the processed Coptis rhizome, including products traditionally processed with different methods, or its processing methods.

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