[关键词]
[摘要]
欧洲药品管理局(EMA)于2022年4月正式发布了欧洲药品管理局草药药品委员会(Committee on Herbal Medicinal Products,HMPC)对草药物质丹参Salvia miltiorrhiza Bunge根或根茎的评估报告草案。其结论为根据现有数据,无法建立丹参的欧盟草药专论。这一结论与传统中医药学对丹参药材的认识和应用,反差极大。重点介绍该报告的评论内容,希望引起中国学术界和企业界的关注,并建议提供数据,包括文献和试验资料,化解EMA的疑问,缩小认识的差距,达到某些共识,促进丹参欧盟草药专论的建立,便于今后丹参制品进入欧洲市场。
[Key word]
[Abstract]
European Medicines Agence (EMA) officially published the draft assessment report of the Committee on herbal medicinal products (HMPC) of the EMA on the herbal substance Salvia miltiorrhiza Bunge, radix et rhizoma in April 2022. The conclusion is that the EU herbal monograph on Salvia miltiorrhiza Bunge, radix et rhizoma can not be established according to the existing data. This conclusion is in great contrast with the understanding and application of Salvia miltiorrhiza in traditional Chinese medicine. This article focuses on the comments of the report, and hopping that it will attract the attention of the academic and business circles in China, and it is suggested to provide data, including literature and experimental data, to resolve the questions of EMA, narrow the understanding gap and reach some consensus,promote the establishment of European Union herbal monograph on Salvia miltiorrhiza, so as to facilitate the entry of traditional Chinese medicine Salvia miltiorrhiza products into Europe in the future.
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