Critical success factors for acceptance of multi-herbal Chinese medicine in Europe

Chinese medicine is one of the treasures of Chinese intellectual contributions to mankind.The character⁃istics that distinguish Chinese medicine from conventional Western medicine find its roots in the philosophical(Daoism)concepts of organizing principles to understand the body,health and disease.Key for worldwide acceptance of traditional Chinese medicine(TCM)is the ability to provide scientific evidence in combination with a quality control system based on the bioactive ingredients.Plant quality in relationship to a bioactivity approach is described that is comprised of a variety of novel approaches based on Systems Biology to tackle these issues.Modern scientific technology tools are now avail⁃able to accomplish standardization of TCM products in order to achieve a high level of efficacy and safety,enhancing the introduction into the international markets.The complexity of the many ingredients and the aspect of synergistic bioactivi⁃ties in TCM,limited the analysis for quality control so far only to the major components for each herb and did not provide evidence for a direct relationship with bioactive components.The systems Biology approach,a multi dimensional chemical and pharmacological approach enables linking of the complex metabolic profile of herbs with biological effects and is therefore a key for quality control of TCM material medica,while providing simultaneous scientific evidence for the under⁃lying efficacy and worldwide acceptance of TCM products.Furthermore,a concept of a business gateway comprising several key steps to unlock the business potential of TCM on Western markets will be presented,including the role of European pharmacopeia as well as community mono⁃graphs of the European Medicinal Agency.

Herbal medicine in the treatment of COVID-19 based on the gut-lung axis

Respiratory symptoms are most commonly experienced by patients in the early stages of novel coronavirus disease 2019 (COVID-19). However, with a better understanding of COVID-19, gastrointestinal symptoms such as diarrhea, nausea, and vomiting haveattracted increasing attention. The gastrointestinal tract may be a target organ of severe acute respiratory syndrome coronavirus2 (SARS-CoV-2) infection. The intestinal microecological balance is a crucial factor for homeostasis, including immunity andinflammation, which are closely related to COVID-19. Herbal medicine can restore intestinal function and regulate the gut florastructure. Herbal medicine has a long history of treating lung diseases from the perspective of the intestine, which is called thegut-lung axis. The physiological activities of guts and lungs influence each other through intestinal flora, microflora metabolites,and mucosal immunity. Microecological modulators are included in the diagnosis and treatment protocols for COVID-19. Inthis review, we demonstrate the relationship between COVID-19 and the gut, gut-lung axis, and the role of herbal medicine intreating respiratory diseases originating from the intestinal tract. It is expected that the significance of herbal medicine in treatingrespiratory diseases from the perspective of the intestinal tract could lead to new ideas and methods for treatment.

复方中草药进入欧洲市场的关键成功因素

中医药是中国人民为人类贡献的宝贵财富之一。中医药在全球范围内被接受的关键是能够提供基于生物活性成分的质量控制系统作为科学证据的能力。目前现代科学技术完全可以实现中草药全产业链的标准化生产,确保药品的质量、有效性和安全性,从而打入国际市场。中草药以药品的身份进入欧盟有多种途径,但是无论哪一种选择,药物的质量都是最重要的。迄今为止,中草药成分的复杂性和其生物活性协同作用的复杂性,对药物质量控制来说仍然是一个挑战。特别是复方中草药的质量控制难度更大。系统生物学方法是一种多维化学和药理学方法,能够将复杂的中草药成分与生物活性联系起来。因此,系统生物学在中药领域的应用是中草药现代化研究领域的关键组成部分,它可以为中医的诊断和中草药的传统使用提供科学证据,从而大力提高中草药产品在全球的接受度。本文讨论了中草药特别是复方中草药进入欧洲的关键点,强调了质量标准的重要性,以及为保障质量标准的落实,执行不同类型的良好的质量管理(GXP)的重要性。同时,介绍了欧洲对植物药安全性和有效性的理解,以及采取的相应管理方法。此外,本文也为说明中草药在欧盟市场上的商业潜力,介绍了一些欧盟成员国常见疾病的OTC市场的情况,他们是注册中草药进入欧盟的主流市场,我们需要对这样的市场规模有一个准确的了解。