Standards Development
This document specifies the quality and safety requirements for the Atractylodis rhizoma that are derived from the rhizome of Atractylodes lancea (Thunb.) DC. And Atractylodes chinensis (DC.) Koidz. This document applies to Atractylodis rhizoma which is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from these plants.
Atractylodis rhizoma, which is the dried rhizome of Atractylodes lancea (Thunb.) DC. and A. chinesis (DC.) Koidz., has been recorded in the Chinese Pharmacopoeia, the Japanese Pharmacopoeia, the European Pharmacopoeia, and the Korean Pharmacopoeia, et al. Indeed, it has been widely used in China, Japan, South Korea, North Korea, Singapore, and other Southeast Asian countries.
Common medicinal products of Atractylodis rhizoma are mainly sourced from Atractylodes plants in East Asian countries such as China. Despite its long history, utilization of Atractylodes plants remains uncontrolled, which is reflected by the origin plant species of Atractylodis macrocephalae rhizoma and Atractylodis rhizoma in Chinese Pharmacopoeia, the Japanese Pharmacopoeia and the Korean Pharmacopoeia. Plants from different sources have different efficacies (even no efficacy in extreme cases). Hence, precise control of primitive species and cultivation of Atractylodis rhizoma is essential for the safety and clinical efficacy of its decoction pieces and other products. Cultivated Atractylodis rhizoma had significant differences in the contents of bioactive components due to genetic differences, environmental factors, and agronomic practices. Additionally, different countries have released different quality standards for quality markers or other components.
However, cultivated Atractylodis rhizoma may have significantly different contents of active components owing to genetic differences, environmental factors, and agronomic practices. Medicinal components of Atractylodis Rhizoma from different plant sources may have different efficacies (even no efficacy in extreme cases). Hence, the quality of cultivated products of Atractylodis rhizoma has dominant impacts on its clinical efficacy and safety and efficacy of products. Nevertheless, different countries have developed different quality standards (e.g., source and contents of marker compounds) for Atractylodis rhizoma as medicine.
Hence, high-quality international standards for Atractylodis rhizoma are urgently needed to guarantee its quality consistency in international trade, clinical efficacy, and safety.
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