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This document specifies the quality and safety requirements and test methods of Plantago asiatica and Plantago depressa seed, which is derived from the seed of Plantago asiatica L. and Plantago depress Willd. (Fam. Plantaginaceae). This document is applicable to Plantago asiatica and Plantago depressa seed that are sold and used as natural medicines in international trade, including Chinese Materia Medica (whole medicinal material) and decoction pieces derived from this plant.
Plantago asiatica and Plantago depressa seed is the dried ripe seed of Plantago asiatica L. and
Plantago depress Willd. (Fam. Plantaginaceae), which is known as Cheqianzi in China. Plantago
asiatica and Plantago depressa seed is a commonly used Chinese herbal medicine with a long history
in China, Japan, Korea, and other East Asian countries. It is traditionally valued and reported to clear
heat, disinhibit urine and relieve stranguria, drain dampness to check diarrhea, improve vision, and
dispel phlegm. Clinically, it is applied in cases of heat strangury with slow pain, edema distention and
fullness, diarrhea caused by summerheat-dampness, red painful swelling eyes, phlegm-heat cough,
etc.
According to the China Customer’ data, there are about 2837 tons on the demand for Plantago asiatica and Plantago depressa seed in the Chinese Materia Medica market in China and Japan during 2017- 2021.
In terms of quality supervision of medicinal materials, the quality and safety of Plantago asiatica and
Plantago depressa seed are regulated in the Pharmacopeia of the People's Republic of China,
Japanese Pharmacopoeia, Korean Pharmacopoeia, and Hong Kong Chinese Materia Medica
Standards. However, specification and quality requirements are not all the same among these
pharmacopoeias and standards, and a unified international standard of Plantago asiatica and Plantago
depressa seed has not yet been done.
In addition, Plantago asiatica and Plantago depressa seed is ranked No. 68 in the updated ISO/TR
23975: Traditional Chinese medicine — Priority list of single herbal medicines for developing
standards, which indicates its high priority. Therefore, it is necessary to establish an international
standard of Plantago asiatica and Plantago depressa seed, which unifies the quality and safety of
Plantago asiatica and Plantago depressa seed, ensures the safety and effectiveness of the medication, and regulates trade in the international market.
This document aims to establish an international standard for Plantago asiatica and Plantago depressa seed to guarantee the clinical effectiveness, safety, and controllability of this valuable medicine in global commerce and trade.
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