TOPIC INSIGHT • 專題探討 2021 UMAGAZINE 24 • 澳大新語 32 Prof Li adds, ‘President Xi Jinping has pointed out that whoever sets the standards has a bigger say, and whoever controls the standards occupies a strategic vantage point. So I believe it is vital to take the initiative to establish standards for chinese medicine for the USP.’ A ‘European Visa’ for Chinese Medicine The Ph. Eur. is the most important reference for quality control of medicines in Europe, and is legally binding in 39 European countries. In 2008, the Ph. Eur. Commission established a working party on TCM (Traditional Chinese Medicine). The Pharmacopeia now includes quality standards for over 80 Chinese herbal medicines, such as Acanthopanacis gracilistyli cortex, Akebiae caulis mutong, and Angelicae sinensis radix, which accounts for about one‑third of all herbs included. ICMS Assistant Professor Chen Xiaojia is devoted to quality analysis of Chinese herbal medicine, in addition to creating international standards for such herbs. Her team has established the European standards for Ophiopogonis radix. Prof Chen says that the principles of TCM and Western medicine are vastly different. She adds that the two systems will not be able to interact with each other if there are no quality standards for medicines. ‘The standards we established for Chinese herbal medicine are essentially their “visa” to Europe. The standards will allow people in Europe to understand Chinese medicine, and will make high‑quality Chinese herbal medicine more accessible across the continent.’ first expert in quality control of Chinese medicine to enter the list since its publication in 2013. For quality control in Chinese medicine, Prof Li’s team has proposed practical strategies that meet international quality standards. Among their achievements are efficient and practical methods for evaluating the standards for Panax notoginseng, as well as six quality standards for the USP Herbal Medicines Compendium and the USP Dietary Supplements Compendium. Prof Li says it is more challenging to establish quality standards for Chinese medicine than for western medicine because the former usually comprise hundreds of natural compounds. For example, the Chinese herbal medicine Panax notoginseng contains saponins, which are naturally occurring compounds that can dispel blood stasis. Therefore, the ChP lists saponins as one of the quality indicators for Panax notoginseng. According to Prof Li, it is also used to stop bleeding because it contains an active ingredient known as ‘dencichine’. ‘For the same Chinese herbal medicine, there should be different quality indicators for different clinical purposes,’ says Prof Li. ‘For example, we proposed including dencichine as a quality indicator for Panax notoginseng for the USP, but some experts were against this idea. However, we persisted and presented evidence from clinical practices. In the end, we convinced the opponents that both dencichine and saponins should be listed as quality indicators.’ 李紹平教授 Prof Li Shaoping 陳肖家教授 Prof Chen Xiaojia
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