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Archive > Volume 17 Issue 1 > 2025,17(1):3-18. DOI:https://doi.org/10.1016/j.chmed.2024.11.008 Prev Next

傳統(tǒng)中藥在歐盟的應(yīng)用現(xiàn)狀、挑戰(zhàn)和展望-聚焦意大利市場(chǎng)

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Traditional Chinese herbal medicine in European Union: State of art, challenges, and future perspectives focusing on Italian market

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    摘要:
    傳統(tǒng)的中草藥(TCM) 作為醫(yī)療保健系統(tǒng)的一個(gè)組成部分，在中國(guó)已經(jīng)使用了數(shù)千年。中藥提取物應(yīng)用非常廣泛，并扎根于歐盟(EU)，是一個(gè)規(guī)模顯著的產(chǎn)業(yè)，特別是食品補(bǔ)充劑領(lǐng)域。最近也有基于中藥提取物的醫(yī)療器械和化妝品，特別是在意大利。歐盟目前只有7種基于中藥提取物的草藥產(chǎn)品(HMP)，而歐洲藥典中有100多個(gè)關(guān)于中藥植物的專論。事實(shí)上，歐洲藥品管理局(EMA)報(bào)告中藥安全性和有效性主要數(shù)據(jù)非常有限，這可能是HMP使用數(shù)量有限的原因。很明顯，那些以中藥為基礎(chǔ)，但未被歸類為HMP的植物藥，是一種典型的“邊緣”產(chǎn)品。與HMP相比，很有可能因?yàn)樗鼈兊氖跈?quán)更簡(jiǎn)單，在歐洲市場(chǎng)上的存在更普遍。本文報(bào)道了在意大利銷(xiāo)售的含有中藥植物的這些類別(食品補(bǔ)充劑和醫(yī)療器械)的一些例子。因此，明確其分類是迫切需要的，也是消費(fèi)者保護(hù)的基礎(chǔ)。無(wú)論是作為食品補(bǔ)充劑、醫(yī)療器械還是化妝品銷(xiāo)售的中藥材，建立歐盟質(zhì)量標(biāo)準(zhǔn)和正式注冊(cè)都是勢(shì)在必行的，因?yàn)閲?guó)際質(zhì)量標(biāo)準(zhǔn)ISO TC 249標(biāo)準(zhǔn)可以協(xié)調(diào)質(zhì)量控制，促進(jìn)國(guó)際貿(mào)易。政府部門(mén)和中藥生產(chǎn)企業(yè)應(yīng)共同努力，加快中醫(yī)藥相關(guān)法律的立法，營(yíng)造中醫(yī)藥不是繼續(xù)存在，而是真正發(fā)展的環(huán)境。

    Abstract:
    Traditional Chinese herbal medicine (TCM) has been used in China for thousands of years as an integral part of the healthcare system.The use of botanical products deriving from plants from TCM has become very spread and rooted in European Union (EU), generating a manufacturing industry of pronounced size, in particular the segment of food supplements, but recently also medical devices and cosmetics based on plants from TCM, especially in Italy. Only seven Herbal Medicinal Products (HMP) based on plants from TCM are present in EU besides more than 100 monographs on TCM plants are present in the European Pharmacopoeia. Indeed, the number of herbal monographs of European Medicine Agency (EMA) which report the main data on safety and efficacy of medicinal plants from TCM are very limited and this could be a reason for the limited number of HMP based on herbal drugs used in TCM. It is clear that those botanicals based on TCM but not classified as HMP can represent a sort of ‘‘borderline” products. Very likely, they are present on the European market because of the simpler authorization when compared with HMP. Some examples of these categories (food supplements and medical devices) containing plants from TCM and marketed in Italy are reported in this review. Consequently, it is urgent the need to clarify their categorization, also fundamental for the consumer protection. It is imperative the establishment of EU quality standards and official registration for Chinese herbal medicinal products, even if they are marketed as food supplements, medicinal devices or cosmetics because the international quality standards International Organization for Standardization Technical Committee 249-Traditional Chinese Medicine (ISO/TC249) can harmonize the quality control and promote the trading internationally. Governmental organizations together with companies producing TCM should work together to accelerate the legislation of laws pertaining to TCM, and generate an environment where TCM does not just continue to exist but truly develop.

    關(guān)鍵詞:
    歐洲和意大利市場(chǎng);食品補(bǔ)充劑;植物藥產(chǎn)品;醫(yī)療器械和化妝品;傳統(tǒng)中藥

    Keywords:


    Project Supported:
    The financial support provided by the MUR - Dipartimenti di Eccellenza 2023–2027 (No. DICUS 2.0) to the Department of Chemistry ‘‘Ugo Schiff” of the University of Florence is acknowledged. Mei Wang’s research is partially support by Dutch subsidy entitled: ‘‘Programma EFRO West-Nederland 2021-2027”.

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