Standards Development
This document specifies the minimum quality requirements and test methods for Ophiopogon japonicus root tuber(the dried root tuber of Ophiopogon japonicus (L. f.) Ker-Gawl). This document applies to Ophiopogon japonicus root tuber sold and used as Chinese materia medica (whole medicinal materials) and decoction pieces derived from these plants. This document does not apply to the processed Ophiopogon japonicus root tuber, including products traditionally processed with different methods, and its processing methods.
1 Basic situation Ophiopogon japonicus root tuber/Maidong is the dried root tuber of the plant Ophiopogon japonicus (L. f.) Ker-Gawl. from the family Liliaceae, which is also known as Maimendong. And it is famous authentic medicinal materials for the effect of nourishing yin, producing fluid, moistening lung and clearing heart. The earliest documentation of this herbal medicine can be traced back to a classical herbal book written about 2000 years ago, “Shennong's Classic of Materia Medica,” which is listed as superior herb with nourishing yin and moistening lung. Ophiopogon japonicus root tuber is non-toxic and can be taken for a long time. Ophiopogon japonicus root tuber has also been recorded in the herbal medicine books of different dynasties throughout China's history and boasts a medicinal history spanning over two thousand years. “Treatise on Febrile diseases", "Synopsis of Golden Chamber" and "Differentiation of Warm Diseases" contain 31 prescriptions of Ophiopogon japonicus root tuber. Among the more than 1600 prescriptions contained in the Chinese Pharmacopoeia (2020 edition), there are 140 prescriptions of Ophiopogon japonicus root tuber. Currently, Ophiopogon japonicus root tuber in updated edition ISO/TR 23975 Traditional Chinese medicine — Priority list of single herbal medicines for developing standards, ranking 48th in priority, it has been included in the European Pharmacopoeia, the British Pharmacopoeia, the Chinese Pharmacopoeia, the Japanese pharmacopoeia, the Korean pharmacopoeia and the Hong Kong Chinese Materia Medica Standard. According to the acute toxicity classification standard, Ophiopogon japonicus root tuber is classified as non-toxic. Saponins are the main active parts of Ophiopogon japonicus root tuber, especially Ophiopogonin D. Ophiopogon japonicus root tuber has the pharmacological effects of protecting cardiovascular system, enhancing immunity, anti-aging skin and anti-inflammatory and other pharmacological effects. However, there are still some concerns on the quality control of Ophiopogon japonicus root tuber, outlined below, which affects the trade and use of this herb. a) Germplasm, origin and other factors have a great impact on the quality of Ophiopogon japonicus root tuber. b) The planting, harvesting and processing methods and techniques have not been standardized. Issues such as low efficiency, large interference from human factors, and poor controllability, seriously affect the quality of Ophiopogon japonicus root tuber materials. c) Even though many countries or regions, e.g., China, Hong Kong China, Japan, Korea, and Europe, have established Pharmacopoeia standards for Ophiopogon japonicus root tuber, the relevant requirements vary significantly, which limits the application of those standards in the global trade. Therefore, it is necessary to complete the establishment of ISO/TC 249 from the aspects of primitive, properties, physicochemistry, effectiveness, safety, detection methods, packaging, storage and other indicators. 2 International market demand for Ophiopogon japonicus root tuber ISO standard 1International Chinese medicine ISO standard status As of now, there are 101 international ISstandards for Traditional Chinese Medicine (TCM), with 30 standards currently under development. In the field of Chinese medicinal materials, ISO standards have been completed and released for major medicinal materials such as Sanqi (Panax notoginseng), Dangshen (Codonopsis pilosula), Baishao (Paeonia lactiflora), Banlangen (Isatis tinctoria root), Danggui (Angelica sinensis), and Gouqizi (Lycium barbarum). These ISO standards of bulk medicinal materials mainly completes the standard formulation from the aspects of provenance, character, physicochemical, safety, detection method, packaging, storage and other indicators. And there is no Ophiopogon japonicus root tuber ISO
standard!
2International market application requirements Over the years, the scale of China's export trade in
Chinese medicinal materials has remained stable with a gradual increase. From 2015 to 2022, the
annual export quantity of Chinese medicinal materials fluctuated around 200,000 tons, while the export
value fluctuated around 1.2 billion US dollars. Overall, there has been a steady and upward trend in the
export trade of Chinese medicinal materials during this period. Among them, Ophiopogon japonicus
root tuber is developed and used as raw materials for food, health care products and medicines, and its
annual export volume exceeding 1,500 tons in Europe, America, Japan, South Korea, Singapore, as
well as Hong Kong China, accounting for 80% of the total national export volume of Ophiopogon
japonicus root tuber. In the field of cosmetics, foreign companies such as L'Oreal Group and LVMH
Group in France, Amorepacific Corporation in South Korea, and ABLE C&C Group extensively utilize
Ophiopogon japonicus root tuber in the formulation of hydrating and moisturizing products in the global
market.
3Broad Prospects in the International TCM Health Market Currently, the global annual transaction
volume of health products related to TCM is nearly 500 billion yuan, with an annual growth rate of 10%
to 20%. Furthermore, the development of the economy and society, improvement in people's living
standards, and increasing awareness of overall health are driving the health product industry to grow at
an average annual rate of around 13%. In 2015, the transaction volume reached approximately 180
billion US dollars. Based on these trends, Ophiopogon japonicus root tuber as an important member of
the TCM health field, Ophiopogon japonicus root tuber and its products are widely used in at least 25
countries and regions, including China, Japan, Germany, Vietnam, India, USA, Malaysia, Korea and
Hong Kong. In 2022, the global import and export volume of Ophiopogon japonicus root tuber was
approximately 1,492,542 kilograms, with a total import and export value of about 16,473,125 US
dollars.
3 Benefits to be gained
1Technical benefits By obtaining international standardization certification, enterprises can get the
guidance of technical specifications, improve product quality and production efficiency, reduce
production costs, enhance market competitiveness, and thus achieve sustainable development.
2Economic benefits The application of Ophiopogon japonicus root tuber international standards can
bring many economic benefits, including improving product competitiveness, reducing production costs,
improving supply chain efficiency, expanding market openness, protecting consumers' rights and
interests, and promoting international trade and cooperation. These benefits help enterprises to
enhance their comprehensive competitiveness and achieve sustainable development.
3Social benefits The development and implementation of Ophiopogon japonicus root tuber international standards help improve product quality and safety, promote industry development and international trade, increase consumer trust, and promote sustainable development.
4Environmental benefits The implementation of international standards of Ophiopogon japonicus
root tuber can effectively protect and improve the environment, reduce resource consumption and
pollutant emissions, and contribute to sustainable development and environmental protection.
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