ISO 22467:2021 伝統的な漢方薬—天然物中の微生物の測定 | ページ 2

Foreword

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

Introduction

Natural products used in traditional Chinese medicine are widely used around the world due to their high medicinal values and mild side effects. It is a common phenomenon that natural products are contaminated by microorganisms which not only impact their quality and efficacy, but also restrict the international trade in them and related products. Although the Pharmacopeia of the People’s Republic of China, the British Pharmacopoeia, the Japanese Pharmacopoeia, the European Pharmacopoeia and the United States Pharmacopeia have stipulated the microbial limits of natural products, there is no International Standard for microorganism detection methods, which adversely affects communication and trade between researchers and factories in different countries. Furthermore, microorganism levels on or in natural products usually exceed the maximum limit levels set by many international organizations and countries due to the lack of an International Standard.

1 Scope

This document specifies test methods to determine microorganisms in natural products. It is applicable only to natural products used in traditional Chinese medicine, including raw materials, herbal pieces and preparations.

2 Normative reference

There are no normative references in this document.

3 Terms and definitions

For the purposes of this document, the following terms and definitions apply.

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Bibliography