Standards Development

Scope

This document specifies minimum quality and safety requirements of Fritillariae cirrhosae bulbus.

Purpose

Fritillariae cirrhosae bulbus are the dried bulbus of Fritillaria cirrhosa D. Don, Fritillaria unibracteata Hsiao et K. C. Hsia, Fritillaria przewalskii Maxim., Fritillaria delavayi Franch., Fritillaria taipaiensis P. Y. Li and Fritillaria unibracteata Hsiao et K. C. Hsia var. wabuensis (S. Y. Tang et S. C. Yue) Z. D. Liu, S. Wang et S. C. Chen in the Liliaceae familywhich is included in the Chinese Pharmacopoeia, Korean Pharmacopoeia, and Hong Kong Chinese Materia Medica Standard. It is a commonly used in traditional medicine and has also been widely used and traded in countries such as Korea, Nepal, Singapore, Malaysia, Japan, Canada, Australia, and Europe. It has pharmacological effects such as antitussive, expectorant, analgesic, anticancer, anti-inflammatory, and antioxidative activities. At present, there are significant differences in the provisions of various pharmacopoeias or standards, which seriously affects the industrial development and international trade of Fritillariae cirrhosae bulbus. 

Fritillariae cirrhosae bulbus is mainly produced in China, Nepal, Bhutan and other countries. The Fritillariae cirrhosae bulbus in the global market mainly comes from China. According to incomplete statistics, China exports over a hundred tons of Fritillariae cirrhosae bulbus each year, including South Korea, Japan, Malaysia, Singapore, Australia, Canada, and Europe. However, there are significant differences in the provisions of various pharmacopoeias or standards regarding the origin plants, medicinal properties, and identification methods of Fritillariae cirrhosae bulbus, which seriously affects the industrial development and international trade of Fritillariae cirrhosae bulbus. Therefore, formulating international standards of Fritillariae cirrhosae bulbus can not only promote international trade of Fritillariae cirrhosae bulbus, but also safeguard the health of all humanity.

On the basis of existing standards in various countries, this project formulates processes and specifications according to ISO international standards, collects samples from countries or regions that mainly produce and consume Fritillariae cirrhosae bulbus, and determines and standardizes their characteristics, including thin-layer chromatography, ethanol-soluble extracts, pesticide residues, heavy metals, and other physicochemical indicators, such as drying weight loss, total ash content, etc