中药配方颗粒关键技术与中医药国际化思考
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摘要
中医药国际化是指传统中医药学在国际社会被完整准确地接受,并在法律保护下规范地应用。其内容包括:①中医药学被国际社会整体接受;②获得所在国家的法律保证并进入主流医疗体系;③中医药学的理论体系和诊疗体系能被现代科学的技术指标和术语所表述,同时被国际社会理解和认可。
中医药国际化问题,是近年我国政府部门、中医药界广泛关注并反复讨论的热点问题。本研究根据导师邓铁涛教授关于“中医药要与世界双向接轨”的学术思想,总结十几年来在中药配方颗粒研制、开发、推广、应用过程中的成功经验,分析其在中医药国际化进程中影响和作用,同时参阅了大量的有关文献和资料,力求找出实现中医药国际化的关键问题所在,探索加快和推进中医药国际化的策略及具体措施,为国家及相关单位在制定中医药国际化推进计划时提供参考。
推进中医药国际化进程,不仅有助于实现中医药文化与世界各国文化的双向交流和双向接轨,而且有助于各国健康保健事业的共同发展,更有利于提高我国民族医药产业的竞争力,促进我国国民经济的发展。
中医药由于其独特的临床疗效已被许多国家以法律的形式列为合法医疗手段。据有关资料统计,目前世界上已有120多个国家和地区设立了中医药机构,全球采用中医药、包括针灸、推拿治疗疾病的人数,已占世界总人口的三分之一以上。美国、澳大利亚等西方发达国家均相继在大学开设了中医专业学位课程。来华接受中医药教育和培训的留学生人数一直稳居自然科学领域来华留学人数的首位,中医药国际交流与合作项目正在成为我国对外合作交流的优势项目。然而,中医药在进一步走向世界的过程中也遇到了一些障碍和问题,其主要表现在:1)中西文化差异及中医药理论表述问题;2)中医药标准化问题;3)中医药产品的安全性问题;4)中医药国际化是单向接轨还是双向接轨问题;5)中医药国际市场法规及贸易壁垒问题。
针对上述存在的问题,我国中医药工作者正在寻求解决问题的办法。十几年来,我们在中药配方颗粒研制、生产和国际市场开拓的实践中,不断探索实现国际化目标的途径,解决了中药配方颗粒在国际社会应用中的有关问题,为中医药国际化提供了有价值的经验和启示。
中药配方颗粒是用符合炮制规范的中药饮片为原料,经现代工业提取、浓缩、干燥、制粒,精制而成的纯中药系列产品,作为新的饮片形式它可替代中药饮片供临床辩证论治、随证加减,配方使用。中药配方颗粒保留了原中药饮片的药性功效,不需煎煮、易于调剂、方便服用、质量可控、作用快速,更符合现代人的消费与生活需求,易为国外消费者认可和接受。中药配方颗粒己广泛应用于美欧东南亚等国家和地区,每年为国家大量创汇,展示出强大的国际竞争优势。其最主要经验是:1)
Internationalization of Traditional Chinese Medicine (TCM) means the traditional Chinese medicine can be accepted completely and accurately by international community and be used normatively under the law. The details of TCM internationalization includes that TCM can be completely accepted by international community and protected under the local law and come into the main medical systems, the system info and system of diagnosis and treat can be described by parameter and language of modern science and technology, and can be understood and admitted by international community at the same time.Our government and TCM academia have been paying more and more attention on the problems of TCM internationalization, and chew it over in recent years. This study was basis on Prof. Deng's theory about "To make TCM two-way integrate with the world market", summarized the Chinese traditional medicine formula granule's successful experience on the development, expansion and application, analyzed its influence on the TCM internationalization, and consulted large numbers of correlative literature. We strived to find out the sticking point of realizing TCM internationalization, quested for the strategies and definite steps of pushing the TCM internationalization, so we can provide reference for the government to establish the correlative policy of TCM internationalization.Pushing TCM internationalization course not only redounds to the realization of making the TCM culture integrate with the world countries culture, is also helpful for the collaborative development of world countries' health care industry. It is better for competitive power of our national medicine industry, and promotes the growth in the national economy.TCM has been legal medical method in many countries because of its unique clinic effect. Now the TCM organizations have been established in more than 120 countries and regions, there are more than one - third of the world's population that have used TCM to cure their disease, including acupuncture and massage. The universities in western developed countries just like American and Australia, etc. have offering TCM degree courses one after the other. In China, the quantity of TCM foreign students is the most of the foreign students in the natural science, and TCM international cooperation and technological exchange has been preponderant item in the communication with foreign
countries. However, there also have some obstacles in the course of TCM internationalization, the main problems include: the culture divergence and explanation of TCM theory, the standardization of TCM, the safety of TCM products, adopting unilateral or bidirectional policy in the course of TCM internationalization, and the problem of TCM international market rule of law and commerce wall.Aiming at these problems, our TCM researchers have been seeking for the solutions to them. For more than 10 years, we have engaged in the development, production and opening international market of the Chinese traditional medicine formula granule, and have been ceaselessly questing for the approach of realizing TCM internationalization. We resolved the application problems on using Chinese traditional medicine formula granule in international society, and provided valuable experience for TCM internationalization.The Chinese traditional medicine formula granules are made by advanced technology and methods, using the eligible decoction pieces of Chinese traditional medicine as raw material, after extraction, purification, concentration, desiccation and forming, then to be series of absolute Chinese traditional medicine products. As a new kind of decoction pieces, it can replace the traditional decoction pieces for prescription preparation. The Chinese traditional medicine formula granules have reserved the efficacy of traditional decoction pieces. Patients don't have to decoct, and prescription is easy to prepare and drink. The formula granules' quality is controllable, and their effect is fast. They accord with the modern consumption and life requirement, and is easy to be accepted by foreigner. Now the Chinese traditional medicine formula granules have been used in America, Europe, Southeast Asia, and many other countries and regions, earning large number of foreign exchange every year, and showing powerful international competitive advantage. Their main experiences include: establishing preparation technology, quality control standards and safety evaluation criterion that recognized by international society, providing convenient dosage form that recognized by international society, increasing the add-value of TCM products, saving Chinese traditional medicine recourses, and developing TCM with medicament.The establishment of quality standard has essential action on TCM modernization and internationalization. Presently, one of the main obstacles of TCM internationalization is the quality standard has not been recognized by international society. Because of the quality standard difference between Chinese traditional medicine and western medicine, Chinese traditional medicine can not enter international society as therapeutic drug. So it is important to resolve the quality-control problem for realizing TCM internationalization. In the study course of Chinese traditional medicine formula granules and their quality standards, we used internationally recognized technique, just like characteristic fingerprints, etc. to solve the problems about identification of Chinese traditional medicine and stability of products. On the other hand, we used modern technical terms to communicate effectively with international medical world, accelerated their understand and degree of belief to Chinese traditional medicine formula granules and increased their comprehension to the
validity and security of Chinese traditional medicine.The academic communion and identity are important conditions for TCM internationalization course. Because of the successful development of Chinese traditional medicine formula granules and its quality standard accepted by international medical world, we can confidently show and introduce our production to American medical colleague, communicate equally with medical administrations in western developed countries. For example, EU Herbal Medicine Administration has discussed with us about cooperation in drafting out EU management criterion of herbal medicine.The successful experience of Chinese traditional medicine formula granules brought our meditation about TCM internationalization. We think seven strategies should be implemented in the course of TCM internationalization.(1) Strategy of Complete PromotionStrategy of complete promotion of TCM internationalization is determined by integration of TCM system. Traditional Chinese medicine is a whole medical system that developed gradually through thousands years of clinical practice. Traditional Chinese drug can be used exactly only when it is under the guidance of TCM system info. It is unilateral and inadvisable to detach Traditional Chinese medicine from Traditional Chinese drug or push a part of Traditional Chinese medicine in the world. That can hardly display its superiority and unique clinic effect.(2) Strategy of Innovation and DevelopmentTCM originates from ancient Chinese culture, and the differences from world culture always produce hindrance to its internationalization. So only when we constantly insist innovating and developing on the basis of succession, we can realize the aim of TCM internationalization. The main contents of innovation include: standout mode innovation of TCM theory, diagnosis and treat technologies innovation of TCM, innovation of Traditional Chinese drug products and preparation technologies, and evaluation methods innovation of TCM curative effect, etc..(3) Strategy of Break through the Key PointsTCM internationalization is a complicated systemic project, so we must give prominence to the key points under limited resource conditions. We can get twice the result with half the effort if we take some key points as basis and impulse it step by step.From the experience of exploring TCM world markets for years, we have realized that different countries and regions have different characteristics. And according to these different characteristics, we should take the countries and regions with stronger economic strength or extensive influence to circumjacent states as the key points, and pour more resource into the pioneering work in these states, impulse TCM internationalization stage by stage. On the other hand, we should take some kinds of diseases that can be remarkably cured by TCM as demonstration, choose some kinds of diseases as breakthrough point, just like nervous system disease, endocrine or immunization disorders, virus infectious "disease, degeneration of joint disease, geriatric disease, etc., and implement strategy of break
through the key points.(4) Strategy of StandardizationThe competition of future international market will be the competition of standard, and who possess the standard will be the leader. The system of TCM international trade standard is the basis of TCM legislation and standardized administration in the world. Now TCM can't be protected legally by international society because it lack of a trade standard which can be accepted and practiced widely by international society and can't be valued and supervised efficiently.Our country is the cradle land of TCM. The systems of TCM education, research, medical treatment and medicine production have been perfect, and the standards about these systems have been established primarily. Those are nice basis for establishing the system of international trade standard. We are duty bound to organize and lead how to establish the system of international TCM trade standard. It's the key point that we adjust ourselves conditions to suit the international society but not unilateral claim acceptance of international society.International TCM trade standard is a vast system, and the TCM standards about clinic effect evaluation, quality control of production and the criterion of the professionals are the basis of TCM standardization, which should be concentrated on, constituted and put in practice.(5) Strategy of Personnel TrainingPersonnel training are the key for TCM internationalization. We should put emphasis on training indigenous TCM personnel abroad, and establish correlative policy to encourage more foreign students to come our country learning TCM. We should strengthen the education on Chinese culture while we teach them TCM knowledge, so make them professionals who have knowledge of culture, education and medicine. It is an important component part that enhance establishment of the base for the clinic practice chiefly.(6) Strategy of Culture PopularizingTCM is a kind of medical system that based on the traditional humanities, social science and natural science. Chinese culture is the basis of learning the knowledge of TCM. So we should firstly strengthen popularizing Chinese culture. We could combine TCM culture with catering culture and tea culture. In TCM communication and cooperation with foreign countries, first of all, we should increase popularizing and penetrating TCM culture, and its means should be more extensive, including the traditional paper media, internet, movie and television etc.TCM is closely bound up with Chinese catering culture. It should be useful to combine TCM culture with catering culture and tea culture in the progress of TCM internationalization.(7) Strategy of Market DevelopmentOne of the important targets of TCM internationalization is to improve the occupancy rate of the TCM products in the international market. According to it, we must improve the
technology content of the TCM products. So it's an important measure to increase the competition power of the TCM products in the international market that creating the platform for TCM innovation and increasing support to innovative variety of TCM products. In addition, it's an important guarantee for market development strategy that settle down some obstacles on the way of TCM products export by government, simplify the proving procedure for endangered herb, shorten the time for certificate, charge reasonably, submit application and give the certificate in one place, and reduce unnecessary courses.Conclusion: This study was based on the practice of the Chinese traditional medicine formula granule's research, popularize and application in international market, quested for the problems of TCM internationalization helpfully, and summarized efficient paths and strategies for TCM internationalization. It's significant to help government making industry macropolicies and promote the progress of TCM internationalization.
中医药国际化问题,是近年我国政府部门、中医药界广泛关注并反复讨论的热点问题。本研究根据导师邓铁涛教授关于“中医药要与世界双向接轨”的学术思想,总结十几年来在中药配方颗粒研制、开发、推广、应用过程中的成功经验,分析其在中医药国际化进程中影响和作用,同时参阅了大量的有关文献和资料,力求找出实现中医药国际化的关键问题所在,探索加快和推进中医药国际化的策略及具体措施,为国家及相关单位在制定中医药国际化推进计划时提供参考。
推进中医药国际化进程,不仅有助于实现中医药文化与世界各国文化的双向交流和双向接轨,而且有助于各国健康保健事业的共同发展,更有利于提高我国民族医药产业的竞争力,促进我国国民经济的发展。
中医药由于其独特的临床疗效已被许多国家以法律的形式列为合法医疗手段。据有关资料统计,目前世界上已有120多个国家和地区设立了中医药机构,全球采用中医药、包括针灸、推拿治疗疾病的人数,已占世界总人口的三分之一以上。美国、澳大利亚等西方发达国家均相继在大学开设了中医专业学位课程。来华接受中医药教育和培训的留学生人数一直稳居自然科学领域来华留学人数的首位,中医药国际交流与合作项目正在成为我国对外合作交流的优势项目。然而,中医药在进一步走向世界的过程中也遇到了一些障碍和问题,其主要表现在:1)中西文化差异及中医药理论表述问题;2)中医药标准化问题;3)中医药产品的安全性问题;4)中医药国际化是单向接轨还是双向接轨问题;5)中医药国际市场法规及贸易壁垒问题。
针对上述存在的问题,我国中医药工作者正在寻求解决问题的办法。十几年来,我们在中药配方颗粒研制、生产和国际市场开拓的实践中,不断探索实现国际化目标的途径,解决了中药配方颗粒在国际社会应用中的有关问题,为中医药国际化提供了有价值的经验和启示。
中药配方颗粒是用符合炮制规范的中药饮片为原料,经现代工业提取、浓缩、干燥、制粒,精制而成的纯中药系列产品,作为新的饮片形式它可替代中药饮片供临床辩证论治、随证加减,配方使用。中药配方颗粒保留了原中药饮片的药性功效,不需煎煮、易于调剂、方便服用、质量可控、作用快速,更符合现代人的消费与生活需求,易为国外消费者认可和接受。中药配方颗粒己广泛应用于美欧东南亚等国家和地区,每年为国家大量创汇,展示出强大的国际竞争优势。其最主要经验是:1)
Internationalization of Traditional Chinese Medicine (TCM) means the traditional Chinese medicine can be accepted completely and accurately by international community and be used normatively under the law. The details of TCM internationalization includes that TCM can be completely accepted by international community and protected under the local law and come into the main medical systems, the system info and system of diagnosis and treat can be described by parameter and language of modern science and technology, and can be understood and admitted by international community at the same time.Our government and TCM academia have been paying more and more attention on the problems of TCM internationalization, and chew it over in recent years. This study was basis on Prof. Deng's theory about "To make TCM two-way integrate with the world market", summarized the Chinese traditional medicine formula granule's successful experience on the development, expansion and application, analyzed its influence on the TCM internationalization, and consulted large numbers of correlative literature. We strived to find out the sticking point of realizing TCM internationalization, quested for the strategies and definite steps of pushing the TCM internationalization, so we can provide reference for the government to establish the correlative policy of TCM internationalization.Pushing TCM internationalization course not only redounds to the realization of making the TCM culture integrate with the world countries culture, is also helpful for the collaborative development of world countries' health care industry. It is better for competitive power of our national medicine industry, and promotes the growth in the national economy.TCM has been legal medical method in many countries because of its unique clinic effect. Now the TCM organizations have been established in more than 120 countries and regions, there are more than one - third of the world's population that have used TCM to cure their disease, including acupuncture and massage. The universities in western developed countries just like American and Australia, etc. have offering TCM degree courses one after the other. In China, the quantity of TCM foreign students is the most of the foreign students in the natural science, and TCM international cooperation and technological exchange has been preponderant item in the communication with foreign
countries. However, there also have some obstacles in the course of TCM internationalization, the main problems include: the culture divergence and explanation of TCM theory, the standardization of TCM, the safety of TCM products, adopting unilateral or bidirectional policy in the course of TCM internationalization, and the problem of TCM international market rule of law and commerce wall.Aiming at these problems, our TCM researchers have been seeking for the solutions to them. For more than 10 years, we have engaged in the development, production and opening international market of the Chinese traditional medicine formula granule, and have been ceaselessly questing for the approach of realizing TCM internationalization. We resolved the application problems on using Chinese traditional medicine formula granule in international society, and provided valuable experience for TCM internationalization.The Chinese traditional medicine formula granules are made by advanced technology and methods, using the eligible decoction pieces of Chinese traditional medicine as raw material, after extraction, purification, concentration, desiccation and forming, then to be series of absolute Chinese traditional medicine products. As a new kind of decoction pieces, it can replace the traditional decoction pieces for prescription preparation. The Chinese traditional medicine formula granules have reserved the efficacy of traditional decoction pieces. Patients don't have to decoct, and prescription is easy to prepare and drink. The formula granules' quality is controllable, and their effect is fast. They accord with the modern consumption and life requirement, and is easy to be accepted by foreigner. Now the Chinese traditional medicine formula granules have been used in America, Europe, Southeast Asia, and many other countries and regions, earning large number of foreign exchange every year, and showing powerful international competitive advantage. Their main experiences include: establishing preparation technology, quality control standards and safety evaluation criterion that recognized by international society, providing convenient dosage form that recognized by international society, increasing the add-value of TCM products, saving Chinese traditional medicine recourses, and developing TCM with medicament.The establishment of quality standard has essential action on TCM modernization and internationalization. Presently, one of the main obstacles of TCM internationalization is the quality standard has not been recognized by international society. Because of the quality standard difference between Chinese traditional medicine and western medicine, Chinese traditional medicine can not enter international society as therapeutic drug. So it is important to resolve the quality-control problem for realizing TCM internationalization. In the study course of Chinese traditional medicine formula granules and their quality standards, we used internationally recognized technique, just like characteristic fingerprints, etc. to solve the problems about identification of Chinese traditional medicine and stability of products. On the other hand, we used modern technical terms to communicate effectively with international medical world, accelerated their understand and degree of belief to Chinese traditional medicine formula granules and increased their comprehension to the
validity and security of Chinese traditional medicine.The academic communion and identity are important conditions for TCM internationalization course. Because of the successful development of Chinese traditional medicine formula granules and its quality standard accepted by international medical world, we can confidently show and introduce our production to American medical colleague, communicate equally with medical administrations in western developed countries. For example, EU Herbal Medicine Administration has discussed with us about cooperation in drafting out EU management criterion of herbal medicine.The successful experience of Chinese traditional medicine formula granules brought our meditation about TCM internationalization. We think seven strategies should be implemented in the course of TCM internationalization.(1) Strategy of Complete PromotionStrategy of complete promotion of TCM internationalization is determined by integration of TCM system. Traditional Chinese medicine is a whole medical system that developed gradually through thousands years of clinical practice. Traditional Chinese drug can be used exactly only when it is under the guidance of TCM system info. It is unilateral and inadvisable to detach Traditional Chinese medicine from Traditional Chinese drug or push a part of Traditional Chinese medicine in the world. That can hardly display its superiority and unique clinic effect.(2) Strategy of Innovation and DevelopmentTCM originates from ancient Chinese culture, and the differences from world culture always produce hindrance to its internationalization. So only when we constantly insist innovating and developing on the basis of succession, we can realize the aim of TCM internationalization. The main contents of innovation include: standout mode innovation of TCM theory, diagnosis and treat technologies innovation of TCM, innovation of Traditional Chinese drug products and preparation technologies, and evaluation methods innovation of TCM curative effect, etc..(3) Strategy of Break through the Key PointsTCM internationalization is a complicated systemic project, so we must give prominence to the key points under limited resource conditions. We can get twice the result with half the effort if we take some key points as basis and impulse it step by step.From the experience of exploring TCM world markets for years, we have realized that different countries and regions have different characteristics. And according to these different characteristics, we should take the countries and regions with stronger economic strength or extensive influence to circumjacent states as the key points, and pour more resource into the pioneering work in these states, impulse TCM internationalization stage by stage. On the other hand, we should take some kinds of diseases that can be remarkably cured by TCM as demonstration, choose some kinds of diseases as breakthrough point, just like nervous system disease, endocrine or immunization disorders, virus infectious "disease, degeneration of joint disease, geriatric disease, etc., and implement strategy of break
through the key points.(4) Strategy of StandardizationThe competition of future international market will be the competition of standard, and who possess the standard will be the leader. The system of TCM international trade standard is the basis of TCM legislation and standardized administration in the world. Now TCM can't be protected legally by international society because it lack of a trade standard which can be accepted and practiced widely by international society and can't be valued and supervised efficiently.Our country is the cradle land of TCM. The systems of TCM education, research, medical treatment and medicine production have been perfect, and the standards about these systems have been established primarily. Those are nice basis for establishing the system of international trade standard. We are duty bound to organize and lead how to establish the system of international TCM trade standard. It's the key point that we adjust ourselves conditions to suit the international society but not unilateral claim acceptance of international society.International TCM trade standard is a vast system, and the TCM standards about clinic effect evaluation, quality control of production and the criterion of the professionals are the basis of TCM standardization, which should be concentrated on, constituted and put in practice.(5) Strategy of Personnel TrainingPersonnel training are the key for TCM internationalization. We should put emphasis on training indigenous TCM personnel abroad, and establish correlative policy to encourage more foreign students to come our country learning TCM. We should strengthen the education on Chinese culture while we teach them TCM knowledge, so make them professionals who have knowledge of culture, education and medicine. It is an important component part that enhance establishment of the base for the clinic practice chiefly.(6) Strategy of Culture PopularizingTCM is a kind of medical system that based on the traditional humanities, social science and natural science. Chinese culture is the basis of learning the knowledge of TCM. So we should firstly strengthen popularizing Chinese culture. We could combine TCM culture with catering culture and tea culture. In TCM communication and cooperation with foreign countries, first of all, we should increase popularizing and penetrating TCM culture, and its means should be more extensive, including the traditional paper media, internet, movie and television etc.TCM is closely bound up with Chinese catering culture. It should be useful to combine TCM culture with catering culture and tea culture in the progress of TCM internationalization.(7) Strategy of Market DevelopmentOne of the important targets of TCM internationalization is to improve the occupancy rate of the TCM products in the international market. According to it, we must improve the
technology content of the TCM products. So it's an important measure to increase the competition power of the TCM products in the international market that creating the platform for TCM innovation and increasing support to innovative variety of TCM products. In addition, it's an important guarantee for market development strategy that settle down some obstacles on the way of TCM products export by government, simplify the proving procedure for endangered herb, shorten the time for certificate, charge reasonably, submit application and give the certificate in one place, and reduce unnecessary courses.Conclusion: This study was based on the practice of the Chinese traditional medicine formula granule's research, popularize and application in international market, quested for the problems of TCM internationalization helpfully, and summarized efficient paths and strategies for TCM internationalization. It's significant to help government making industry macropolicies and promote the progress of TCM internationalization.
引文
[1] 甘师俊等:中药现代化发展战略,科学技术文献出版社,1998年7月
[2] 贾谦、段黎萍等:中医药发展现状与前景,战略与管理,2002年1月:65-74
[3] 林中鹏:新世纪中医药产业发展战略思考,2002年5月6日,广州会议报告
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[7] 贾谦、杜艳艳等:中医药走向现代化国际化的发展战略,中国药业,2002,11(2):8—11
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