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Standards Development
This document specifies the minimum requirements and test methods of Coix lacrymajobi var. mayuen seed [the dried ripe seed of Coix lacryma-jobi L. var. maj/uewRoman.Stap. This document applies to Coix lacrymajobi var. mayuen seed that are sold and used as natural medicines in international trade, including Chinese materia medica.
Coix lacrymajobi var. mayuen seed, is the dried ripe seed of Coix lacryma-jobi L. var. maj/uew Roman.Stap, and is a well-known traditional Chinese medicine. Currently, it is commonly used as one of the main traditional Chinese medicines (TCMs) in over 100 prescriptions based on its wide spectrum of biological and pharmacological activities, for treating edema, athlete's foot, poor urination, spleen deficiency and diarrhea, and cancer, etc. Coix lacrymajobi var. mayuen seed oil extracted has also been developed as an anti-tumor agent. The global import and export trade volume is huge with sustainable growth in recent years, and the countries of trade mainly include South Korea, Japan, United Kingdom, United States, Australia, Thailand, Vietnam, etc. However, Coix lacrymajobi var. mayuen seed still has the following concerns in quality and safety control: 1) The processing method, storage pattern and operation technology of Coix lacrymajobi var. mayuen seed have not been standardized, which and may affect the quality and safety of medicinal materials. 2) The requirements of Coix lacrymajobi var. mayuen seed are different in different countries, including China, Japan, Korea, American and European. The applicability of standards is limited and affects international trade. 3) Coix lacrymajobi var. mayuen seed ranked the 128 in the ISO/TR 23975: 2019 Traditional Chinese medicine — Priority list of single herbal medicines for developing standards, which is in the high priority of developing international standards. The purpose of this document is to establish an international standard for the quality and safety control of Coix lacrymajobi var. mayuen seed, ensure the safety and effectiveness of clinic drug use, regulate the international market, and reduce the occurrence of adverse events.
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