Foreword

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This document was prepared by Technical Committee ISO/TC 249, Traditional medicine, Subcommittee SC 1, Traditional Chinese medicine.

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Introduction

Ganoderma lucidum spore is the reproduction unit of Ganoderma lucidum, which is also known as Lingzhi or Reishi. The spore has a double-layered spore wall (sporoderm) mainly composed of chitin. The sporoderm cannot be digested and degraded in the body, thus hindering the release and absorption of active components such as polysaccharides and triterpenoids. Therefore, the sporoderm-breaking process is critical to improving the effect and bioavailability of Ganoderma lucidum. Currently, the mainstream sporoderm-breaking methods include extrusion, grinding, shearing, jet pulverization, etc., and mainly use equipment such as vibration mills, homogenizers, and supersonic jet pulverizers.

Sporoderm-broken Ganoderma lucidum spore powder is gaining increasing acceptance and popularity as an herbal medicine and a dietary ingredient, and possesses various bioactivities, including immunomodulation, liver protection, and antitumor effects. The industry has developed rapidly and its market share has gradually expanded. The yield of Ganoderma lucidum spore powder in China was about 10 000 t in 2020, with a growth rate of 12,72 %, and the output value was 3,814 billion CNY, accounting for 47 % of the total Ganoderma lucidum industry. In the international market, Japan, the Republic of Korea, USA, Malaysia and other countries and regions have large-scale enterprises that produce and sell Ganoderma lucidum spore powder products. According to incomplete statistics, the annual sales of Ganoderma lucidum and Ganoderma lucidum spore powder related products exceed one billion USD.

However, quality standards of sporoderm-broken Ganoderma lucidum spore powder are lacking. At present, there is no pharmacopoeia standard for the quality of sporoderm-broken Ganoderma lucidum spore powder. Therefore, it is necessary to develop an International Standard to ensure the safety, effectiveness and quality of sporoderm-broken Ganoderma lucidum spore powder and related products. This document promotes sporoderm-broken Ganoderma lucidum spore powder and related products in the market by clarifying the chemical composition and active components of Ganoderma lucidum spore powder through systematic research.

As national implementation can differ, national standards bodies are invited to modify the values given in 4.4, 4.5 and 4.7 in their national standards. Examples of national and regional values are given in Annex F.

1 Scope

This document specifies requirements and test methods for sporoderm-broken Ganoderma lucidum spore powder that is derived from Ganoderma lucidum (Leyss. ex Fr.) Karst.

It is applicable to sporoderm-broken Ganoderma lucidum spore powder that is sold and used as natural medicine and raw material for health products in international trade.

2 Normative references

3 Terms and definitions

4 Requirements

4.1 General characteristics

4.2 Microscopic features

4.3 High performance liquid chromatography (HPLC) identification

4.4 Moisture

4.5 Total ash

4.6 Peroxide value

4.7 Sporoderm-broken rate

4.8 Aflatoxins B₁

4.9 Marker compounds

4.10 Microorganisms

4.11 Heavy metals

4.12 Pesticide residues

5 Test methods

5.1 General characteristics

5.2 Microscopic identification

5.3 High performance liquid chromatography (HPLC) identification

5.4 Determination of moisture content

5.5 Determination of total ash

5.6 Determination of peroxide value

5.7 Determination of sporoderm-broken rate

5.8 Determination of aflatoxins B₁

5.9 Determination of marker compounds

5.10 Determination of microorganisms

5.11 Determination of heavy metals

5.12 Determination of pesticide residues

6 Test report

7 Packaging, storage and transportation

8 Marking and labelling

Bibliography

ISO/TS 25006:2025

Traditional Chinese medicine. Sporoderm-broken Ganoderma lucidum spore powder

Current

Published:

15 Jul 2025