Standards Development

Scope

This document specifies the quality and safety requirements for Cyperus rotundus rhizome that are derived from the dried rhizome of Cyperus rotundus L. This document applies to Cyperus rotundus rhizome that is sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.

Purpose

Cyperus rotundus rhizome is the dried rhizome of Cyperus rotundus L.(Fam.Cyperaceae). Collected in autumn, burnt off the fibrous roots, boiled briefly or steamed thoroughly and dried in the sun, or dried in the sun directly after burning off the fibrous roots. Cyperus rotundus rhizome is included in Chinese Pharmacopoeia, Hong Kong Standard of Chinese Medicinal Materials (Volume 1-10), The Japanese Pharmacopoeia (18th edition)and The Korean Pharmacopoeia (12th edition). The pharmaceutical name of Cyperus rotundus rhizome is Cyperi rhizoma, in Chinese called (Xiangfu), also named as Nutgrass galingale rhizome in English, in Japanese, andin Korean. As an important Chinese herbal medicine, it is widely used in China, Japan, Republic of Korea, India, Arab countries, African countries and so on. In China, Cyperus rotundus rhizome, firstly recorded in Tao Hongjing's "Supplementary Records of Famous Physicians" of the Liang Dynasty has the effects of soothing the liver, resolving depression, regulating qi, soothing the middle, regulating menstruation and relieving pain. Modern studies have shown that it has analgesia , anti-inflammatory, antibacterial, antidepression and other pharmacological effects. Cyperus rotundus rhizome is not only an important international natural medicine, but also widely used in cosmetics and health food. At present, there are more than 500 kinds of prescription preparations containing Cyperus rotundus rhizome, including Xiangfu ills, Sizhi Xiangfu pills, Yueju Baohe pills, Dingkun pills, Xiangsha Pingwei granule and etc.. In addition, there are more than 20 kinds of health care products and 40 kinds of cosmetics containing Cyperus rotundus rhizome. The annual international trade volume of the herb is more than50,000 tons, and the total trade volume is more than 300 million dollors and the trade is mainly carried out between China, Republic of Korea, Japan, Vietnam, Ireland, Malaysia, America, and Thailand. Among them, the international trade volume of single herbal medicine between China and Japan ranked 69th in 2017-2021, with an international trade volume of 2560 tons. Cyperus rotundus rhizome is listed in Traditional Chinese medicine - Priority list of single herbal medicines for developing standards (ISO/TR 23975:2023) numbered 82nd in the top 150 of the list. The Chinese Pharmacopoeia, Hong Kong Standard of Chinese Medicinal Materials, The Korean Pharmacopoeia and The Japanese Pharmacopoeia have all formulated standards for the herb, but there are differences in the characteristics, identification methods, physical and chemical indexes and content determination of each standard. For example, there are differences in the content determination among different pharmacopoeias. Hong Kong Standard of Chinese Materia Medica uses -cyperone as the content determination index, while Chinese Pharmacopoeia, The Japanese Pharmacopoeia and The Korean Pharmacopoeia limit the total amount of volatile oil. Among them, Chinese Pharmacopoeia stipulates that the total amount of volatile oil is not less than 1% (ml/g), while The Japanese Pharmacopoeia and The Korean Pharmacopoeia stipulate that the total amount of volatile oil is not less than 0.3 ml(50.0 g, silicon resin 1 mL). The lack of universal standards in the international affects the industrial development and international trade of Cyperus rotundus rhizome.

On the basis of existing standards in various countries or regions, this project collects samples from countries or regions that mainly produce and consume the herbs, then conducts research, determination and standard regulations on their properties, microscopic identification, thin-layer identification, moisture, total ash, alcohol-soluble extractives, content determination, heavy metal and pesticide residues, in accordance with the formulation process and specifications of ISO international standards. Finally promote the release of Chinese herbal medicine Cyperus rotundus rhizome attached ISO international standards..(Please use this field or attach an annex)