Abstract Traditional Chinese Medicine (TCM) has a long history of thousands of years, but it performances weaker and weaker in international market. However, there is no excuse to give it up and make it emerge of itself and perish of itself in the endless flow of history. Because of that, we put our efforts on the internationalization of TCM. At the same time, Western Medicine, which is based on Physics, Chemistry and Biology, has problem on dealing with new incurable illness, and has problem with the subhealth situations which is quite popular now. Thus, people begin to make their eyesight focus on traditional medicine again, and hope those traditional herbs will be helpful to these new problems. Just because of these reasons above, the internationalization of TCM will be more significative. To the subject of TCM's internationalization, many experts have done a lot of work from the directions of Pharmacology and Natural medicinal chemistry. Just because of their efforts, more herbs have been analysed clearer and clearer, more and more nature products have been explained exactly on their mechanism. These achievements have been very helpful to the internationalization of TCM. However, if every mechanism of TCM and each nature component in those herbs could be completely explained? If it could, is there any usefulness and significance left for Traditional Chinese Medicine? Accompany with the appearance of these questions and misgivings, people have come back to the very beginning of this problem, just why TCM performance so weak in the international market? As the author's opinion, the possible and feasible way to the internationalization of TCM could be established only if this question has been well answered. This thesis has tried to change another angle of view to analyse this problem. Since the angle of TCM's popularization, the thesis try to find out those problems to the internationalization of TCM, and try to find out the approach to deal with it. As the author's opinion, it is the essential base to understand the real reasons about why TCM is difficult to be accepted by the international market. Without the understanding, it is difficult to suit the remedy to the case of TCM's internationalization. Just because of that, the thesis tries to understand and compare the laws and regulations of herb's registration inside and outside of China. Through the comparison of laws and regulations, the author has found that there are two chief barriers to the internationalization of TCM, culture barrier and technology barrier. Culture barrier means that the people and governments in those countries without long history of herb use will not recognize and accept TCM because of their different culture. And technology barrier means that the countries with high technology ask for strict standards to TCM which it can not been achieved in China. After this compare, the thesis hold the opinion of that the two barriers are the most important problems for the internationalization of TCM. Thus, to deal with this problem, the thesis has tried to find two possible approaches. To the culture barrier, the possible method is selling TCM as health food at first. Accompany with the acceptation of local people, TCM may be recognized and accepted better as a drug. To the technology, it is the only pathway to accept their reasonable standards. Put their advanced and reasonable standards into our own regulations will improve the safety, efficacy, and controllability of TCM, and will improve the internationalization of TCM at last. According to the primary analysis above, the thesis hope to understand more about the situation and prospect of TCM, and hope to establish some base for the research of the internationalization of TCM. Key Words: TCM, Internationalization, Barriers, Approach, Registration, Laws and regulations, Compare -4-

澳门大学硕士学位论文 摘要 中医药有着几千年的悠久历史,但是近代以来却逐步丧失了广表的市场。 然而,我们没有理由在历史长河的洗刷中,逐步放弃中医,让其自生自灭、放 任自流。所以,我们今天提出了中药国际化的设想。与此同时,以物理、化学 和生物学为主要支撑的西医,面对癌症、心脑血管疾病等等出现了暂时难以攻 克的困难,面对亚健康状况、保健不到位等等影响人类生活质量的问题出现了 束手无策的窘境。所以,人们又一次把目光放回到传统医学中来,期待着传统 医学能够在保障健康、缓解衰老等等一系列问题上对人们有所帮助、有所启 示。因此,在这样的情况下,中医药的国际化又有着其特殊的意义。 对于中药国际化这样一个课题,很多专家和学者从药理学、天然药物化学 等方面做了大量的努力,把越来越多的植物药分析清楚,用化学的机理解释清 楚了一个又一个中药或中药组分,使得中药被大家的认同程度日益提升。前辈 们在这方面的努力对于中医药的国际化有着不可磨灭的功勋和意义。但是,是 不是每一个中医理论、每一味中药都可以用化学和药理学解释清楚?即使是, 如果都可以解释清楚,都可以合成出来,那么还要中医药理论有什么用?这些 问题的逐渐提出,让我们又一次回到了问题的根本———究竟为什么中医药在国 际市场的竞争力如此衰弱?作者认为,只有解释清楚这样一个问题,才能够真 正为中医药国际化找到一条切实可行的道路。 本文尝试着换一个角度来分析这样的问题,从实际推广的角度,来看看中 药究竟在进入国际市场时会遇到哪些问题,又应该如何解决这些问题。因为, 作者认为,只有在清楚地了解了中药为什么难以进入国际市场的真正原因,所 谓的中药国际化才可以对症下药。所以,本文找到了法律法规这样一个切入 点,旨在分析清楚中国内地是如何管理药品、如何管理植物药的;进而将这样 的管理和国际市场上其它地区相应的法律法规进行比较。 通过比较,作者发现,中药国际化中壁垒可能有很多,但是最为主要的, 并且使我们从技术的角度可以尝试突破的主要有两个方面,一是文化壁垒,二 是技术壁垒。所谓文化壁垒,就是说其它国家由于缺乏长期的植物药使用历 史,而对于植物药从文化上没有认同和接受。所谓技术壁垒,就是说其它国家 对于药品注册的技术要求比较高,我们暂时没能达到。本文通过比较认为,这 -1- 澳门大学硕士学位论文 两个壁垒是中药国际化突破国际市场的首要问题。 那么,为了解决这样的问题,本文试图提出两个方面的国际化途径建议。 对于文化壁垒,本文认为,可以暂时先将药品以食品的身份销售出去,伴随着 目标市场的人群对于该植物逐渐了解、接受,进而再以药品的身份出现,可能 可以有助于突破文化方面的不认同。对于技术壁垒,作者认为,可以分析一下 别国的技术要求是否具有充分的合理性。如果确实合理,那么我们可以将其融 入我国药品注册的要求中来,进而切实提高中药自身的安全性、有效性和可控 性,以突破技术壁垒。 通过这些浅显的分析,本文期望能够对于中药国际化的状况和前景有一个 初步的认识和预测,为后来中药国际化方面的努力奠定一定的基础。 关键词:中药国际化、壁垒、途径、注册法规、比较 -2-