ISO 23964:2022 漢方薬 — サポシニコビア・ディバリカータの根と根茎 | ページ 2

Foreword

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This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.

Introduction

Saposhnikovia divaricata root and rhizome is the dried root and rhizome of Saposhnikovia divaricata (Turcz.) Schischk. It was first recorded in the book Divine Farmer’s Classic of Materia Medica, a commonly used reference material in various countries. Saposhnikovia divaricata root and rhizome has long been used in traditional Chinese medicine for its multiple therapeutic properties (antipyretic, analgesic, sedative, anti-inflammatory, anti-allergic and anti-convulsion). It is a highly regarded traditional Chinese medicine with significant medicinal and economic value around the world. Due to annually increasing domestic and international demand, cultivated herbs have begun to replace wild herbs on the market. The markets of Japan, Korea, Germany, and China, amongst others, have a large circulation of Saposhnikovia divaricata root and rhizome.

Saposhnikovia divaricata root and rhizome is mainly distributed in the northeast China (Inner Mongolia, Heilongjiang, Liaoning, Jilin), which are the major production areas of China and account for more than 80 % of national production. It is also planted in Hebei and Shanxi Provinces. The qualities of Saposhnikovia divaricata root and rhizome from the producing areas differ in their appearance and chemical contents when comparing cultivated and wild ones. Therefore, the work for identification and quality evaluation of Saposhnikovia divaricata root and rhizome is highly important.

Although Saposhnikovia divaricata root and rhizome has been recorded in Chinese Pharmacopoeia (2020 edition), Japanese Pharmacopoeia (17th edition), and Korean Pharmacopoeia (10th edition), these standards are not harmonized and can be unsuitable for the purpose of international trade of Saposhnikovia divaricata root and rhizome. Therefore, it is of utmost urgency to standardize the quality of Saposhnikovia divaricata root and rhizome in the world. This action will benefit consumers (patients), farmers, enterprises and companies related to the planting, management and trade of Saposhnikovia divaricata root and rhizome.

As national implementation can differ, National Standards Bodies are invited to modify the values given in 5.3, 5.4, 5.5 and 5.7 in their national standards. Examples of national and regional values are given in Annex D.

1 Scope

This document specifies the quality and safety requirements of Saposhnikovia divaricata root and rhizome derived from the plant of Saposhnikovia divaricata (Turcz.) Schischk.

It is applicable to Saposhnikovia divaricata root and rhizome that is sold as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) 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.

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