摘要
研究制订国际标准化组织(International Organization for Standardization,ISO)中草药国际标准已成为中药国际化和标准化的新热点,国际标准化组织/中医药技术委员会(ISO/TC249)为制定中草药标准提供了国际平台。青风藤作为疗效确切且在国际范围内有一定应用的传统中药材,也应通过制订国际标准的形式在全球层面建立统一的质量与安全控制标准。现有文献研究显示,青风藤存在较多别名,品种混淆与掺伪问题较严重。以青藤碱为主的生物碱是其主要药理活性成分。通过分析中国、日本、韩国及欧洲药典发现,中国、欧洲药典均以青藤碱作为青风藤的质量控制指标;日本、韩国药典对青风藤的质控要求较为相似,但韩国药典更偏重对安全性的要求。建议收集青风藤全球贸易数据和样本进行质量与安全性研究来制订青风藤ISO国际标准。
To conduct research and stipulate international standards of Chinese herbal medicine under the guildance of International Organization for Standardization(ISO)has become a new hot spot of internationalization and standardization of traditional Chinese medicines.International organization for standardization/technical committee of traditional Chinese medicine(ISO/TC249)provides a international platform to develop the standards of Chinese herbal medicine.Sinomenii Caulis,as a traditional Chinese medicine with obvious clinical effect which is used internationally,it’s necessary to establish a unified quality and safety control standards at international level.The current literature showed that there are many aliases of Sinomenii Caulis,and the problem of its variety confusion and adulteration is serious.Sinomenine-based alkaloids were the main pharmacological active components of Sinomenii Caulis.By analyzing the pharmacopoeias of China,Japan,South Korea and Europe,it was found that both Chinese and European Pharmacopoeias take sinomenine as the quality control indicator of Sinomenii Caulis.The Japanese and South Korean pharmacopoeias had similar quality control requirements of Sinomenii Caulis,and the South Korean pharmacopoeia pays more attention on safety requirements.Thus,it is suggested that setting ISO standards of Sinomenii Caulis requires the collection of global trade data and samples of Sinomenii Caulis for future quality and safety research.
作者
黄虞枫
徐美渠
刘良
桑珍
周华
Huang Yufeng;Xu Meiqu;Liu Liang;Sang Zhen;Zhou Hua(Faculty of Chinese Medicine,Macao University of Science and Technology,Macao 999078,China;State Key Laboratory of Quality Research in Chinese Medicine,Macao University of Science and Technology,Macao 999078,China;Institute of International Standardization of Traditional Chinese Medicine,Shanghai Academy of Traditional Chinese Medicine,Shanghai 201203,China)
出处
《国际中医中药杂志》
2020年第7期629-634,共6页
International Journal of Traditional Chinese Medicine
基金
国家自然科学基金(81628016)
澳门科学技术发展基金(062/2017/A2)
上海市进一步加快中医药事业发展三年行动计划(2018年-2020年)[ZY(2018-2020)-GJHZ-1003]。
