【作者】 余依婷；

【导师】 刘小斌；

【作者基本信息】 广州中医药大学 ， 中医医史文献， 2011， 博士

【摘要】 研究目的台湾自古以来就不是中药的主要生产地区、大多数中药资源须仰赖进口提供。自明清以降,带有中国传统医药理论的大陆进口中药材,再加上台湾本地民间草药的使用经验,二者共存并用,成为台湾中草药的在地文化特色。十九世纪末,清王朝因战败将台湾割让与日本之后,殖民地政府有计划地引入西式医学教育及建立公共卫生体系,民间则延续中国中医药与台湾民间草药的传统,但也开始学习流传到台湾的日本汉方医学临床经验。台湾光复、日本战败、国民政府迁台之后,众多的大陆菁英及传统中医药人士来台,受过西方科学思潮洗礼的科学家与西医师,及满腹经纶的名中医,同时主导着台湾中医药体系的发展。1960年代初期,台湾在中药本地资源有限的前提下,以“中药科学化”为基础,导入了以西药制剂为基础而开发的中药科技,开发了具有高度创意的“中药浓缩制剂”,自此奠定了台湾中医药产业朝向中药科技高度发展的现代化主轴,台湾与中国大陆的中医药体系开始往不同的方向演进。对台湾自1949年起迄今的中药科学化发展历史进行系统性探讨,可以填补我国中医药发展历史的研究空白,建立台岛地区中医药科学体系发展架构之研究骨干,对海峡两岸及国际有关传统医药发展战略提供借鉴经验与学术支撑。因此,研究台湾的中药科学技术发展进程,具有历史性及科技前瞻性的现实意义。研究方法本论文采用历史研究方法,即对台湾社会中医药历史发展过程的相关资料进行发掘、收集、调研、整理、描述、分析、归纳的综合系统方法,以时间顺序、以医学事件、以著名人物著作及学术成就等为切入点,对自明清以来台湾医药早期情况、日据时代及至1949年国民政府迁台迄今影响台湾中药科学发展进程的重大事件人物进行研究。具体包括：文献回溯分析：围绕台湾中药科学化发展历程,进行文献资料的查询收集,发掘整理,归纳分析,探讨台湾中药科学发展的学术内涵及社会背景,而资料的来源除图书报刊杂志外,更应该重视人物访谈及田野调查的记录。公文征集归类：主要针对政府公报、法令规章、会议论文、报刊杂志等关于中药科学化及中药科技的相关文献进行搜集整理。个案剖析探究：针对产业体系(顺天堂、胜昌制药等二家成功发展中药科学化制剂的标竿企业),行政体系(卫生署、药政处、中医药委员会、药物食品检验局、药物食品管理局)选取具有代表性的个案进行分析,以了解其对台湾中药科学化的重大影响。口述历史及专家访谈：针对台湾中医药产业相关人士进行访谈,包括专家、学者、研究人员、卫生行政人士、教育工作者、产业工作者等,以求全面汇整台湾中药科学化的有关情势,并深入了解发展中药科技发展之解决方案。本论文研究采用的参考文献包括数据库资料,来源主要有台湾近代医疗文物数据库系统、台湾政府公报信息网、全国法规数据库、中医药信息网。研究结果遵循上述研究方法,在占有大量史料基础上,形成本论文的正文三个部份与附录六个专篇。论文正文“台湾中药科技发展史研究”,重点针对台湾中药科学技术发展的代表人物及事件进行记述。从日据时期到二十世纪底,台湾的中药科学化从局限于实验室的学术研究,成为医学界可具体接受的中医药处方新观念,并发展成为可于临床医疗使用的中药浓缩制剂。奠定台湾中药科学化发展基础的科研者以杜聪明、颜焜荧、许鸿源为主要代表人物。第一部份台湾历史背景之回顾及医药资料收集整理,以中医药人力变迁之统计,检视台岛地区医药历史的沿革。从传教士医疗进入台湾起,台湾民众接触到西医技术及西药治疗,开始期望医药现代化。日本殖民政权把当代国际卫生观念及医学研究思想带入台湾,建立西医学校,台湾人可在本地或到日本接受科学的研究训练,培养出一批批具有现代化思潮的西医药科研菁英。反观国民政府及日本政府对中医药均采取漠视或逐步淘汰的旁观态度,中医药行业只能朝向卖药或民间行医发展,中医药教育只靠父子或师徒相传,中医药科研无法建立学术及研究的体制化基础。第二部份奠定台湾中药科学化发展的先行者,找出开展台湾中药科学化的探索力量。①台湾中药科学化发展的先行者杜聪明。开台第一位医学博士杜聪明,于日据时期在台湾倡导汉医药研究思想,选定台湾本土药用资源作为研究对象,倡议于台大医院及高雄医学院附设医院设立汉医治疗门诊,坚持于西化制度的台大医学院及高雄医学院亲自主讲中西医学史略及中医药学评论,导入伤寒论、本草学、针灸学成为西医教育一环,在“中西医学一元化”的理念下,撒下了“中药科学化”台湾生根萌芽的种子。②台湾中药科学化的开创者颜焜荧。如果说张仲景《伤寒论》开创了中医临床治疗进入汤剂的新纪元,那么颜焜荧对中药浓缩制剂制定产制流程与质量标准的作为,可算是开创了中医临床治疗进入科学化制剂的里程碑。颜焜荧为日本京都大学药学博士,开发日本长仓制药第一款汉方新处方“人蔘当勺散”取得药证审批。首先开发出台湾第一个“中药科学化中药浓缩制剂产品原型,协助转移至顺天堂药厂。率先制定及统一中药浓缩制剂质量指标。创立“颜氏汉方理论”,以台北医学院为基地教育出最多中药科研人材。台湾中药科学化研究的泰斗颜焜荧是唯一在台湾二度荣获政府壹等奖励之中医药科学家。③许鸿源创立顺天堂药厂,并担任台湾省卫生试验所副所长及卫生署药政处第一任处长、卫生署药物食品审议委员会主任委员,在中国文化学院指导药用植物研究,始终强调中药研发检验技术的重要性,以“免煎易服、药效确实”宣传中药浓缩制剂,打响顺天堂制药厂“科学中药”,透过其创立的台湾必安研究所及美国汉方医药研究所检验数据证实科学中药质量,许鸿源实为台湾中药科学化的实践者。第三部份中药科学化在台湾发展及其影响,说明中药科学化对台湾中药制造产业的影响,并解释台湾中药浓缩制剂的演进、质量评估及检验方法的开发、临床试验及新药开发等中药科技技术发展过程。①台湾区制药公会主任委员李沐勋先生发展中药浓缩制剂之主要贡献—导入日本汉方GMP观念于台湾,推动中药GMP产业训练。主持《订定中药标准方》研究计划,成为日后《台湾传统药典(中华中药典)》公告《中药基准方200方》之基础。②中药制造厂在研发制造中药浓缩制剂的时候,必须参考《中药基准方200方》,影响中药厂对配方、包装、制造、申请全民健康保险费用给付等策略,连带地也会影响产业界的科研开发意愿。③以“中药科学化”方式制造中药浓缩制剂的中药厂,由顺天药厂及胜昌制药在上世纪60年代为首创。截至2011年1月1日,台湾实施中药GMP的中药厂将近120家,浓缩制剂中药厂将近50家,仍然是以顺天堂集团及胜昌制药的中药科研实力最为突出,为台湾生技医药产业的中药制造标竿典范。笔者认为上述研究结果具有以下价值：①开创中医药临床体系的临床决策新流程,②新科技的传播在于说服大众的过程,③台湾的中药科学化将处于动态的演进。在完成学位论文过程中,笔者积累1949年迄今的资料,汇编成为论文的第二部份“台湾中药科技发展进程及史料汇编”作为附录。分成六个专篇讨论①现代化科学标准管理中药制造,②以中药为基础的新药开发,③与中药管理有关的政府机构,④中药管理的有关法规,⑤中药科研之重大计划及主要机构,⑥台湾中药制造产业的发展。具体说明卫生署、中医药委员会、食品药物管理局、中央健康保险局与全民健保、国立中国医药研究所等单位与推动台湾中药科学化之关连性。中药科学化产品个案说明包括第一张中药新药药品许可证“寿美降脂一号胶囊(卫署药制字第047152号,2005年9月30日核可)”,及第一张植物新药药品许可证“怀特血宝PG2黄耆多醣注射剂(卫署药制字第054853号,2010年6月24日核可)。研究结论台湾中药科技发展史是当代中医药学史的组成部分,它从一个侧面反映了台湾自1949年国民政府迁徙迄今医药学发展的历史进程,台湾医药学界为努力发展中药科学技术所采用的模式及所取得成就。本论文以此为题材进行研究,其创新点：一是从史料汇集的层面,系统性记录台湾中药科学化的历史进展,资料具有原创性及“存史”价值。二是对台湾中药科学化具有奠基贡献的杜聪明、颜焜荧、许鸿源等三人之学思历程及科研经验进行研究。三是总结台湾中药科学化理念与实质学术内涵,其与中药制品质量管理标准、与临床试验的演进新药开发、与台湾中药制药GMP、与中药基准方二百方颁布相关。台湾同样也肩负着对全球传播交流中医药文化的重责大任,以中药科学技术手段所创造的实体产品,正是利用现代科学语言帮助国际友人理解中医药传统文化内涵的一大助力。深入研究中医药这个属于全人类共同所有的丰富宝藏,考察台湾推动中药科学化及发展中药科技的历程,共同探索中医药,传承中医药,将是海峡两岸中华文化大融合的必然。更多还原

【Abstract】 Research Background and GoalTaiwan was not the main production site for Traditional Chinese Medicine (TCM) raw material since ancient time. Most of the TCM rely on import. The imported TCM from China’s mainland blended with the local herb experience constitute the unique local Taiwanese cultural characteristics. The colonial Japanese government started to systematically introduce the western medical education and public health system to Taiwan after Chinese Chin government lost the war and later on relinquished Taiwan sovereign to Japan in late 19 century. The folk society, while absorbing the clinical experience from Japanese Han Medicine, continued its local TCM practice. After 2nd WW, Taiwan was handed back to China. Quite a few well-known clinically experienced TCM elite practitioners and western medical trained doctors and scientists moved to Taiwan after the 1945-1949 Chinese civil war; together they led the modernization of Taiwan TCM development since then. In early 1960s, under the restriction of limited supply of TCM raw material resources, local Taiwan TCM pharmaceutical manufacturers undertook modern pharmaceutical techniques to develop the highly innovative dosage form "concentrated TCM powder" and known by the general public as the popular name of "scientific TCM". This approach had lay down the future foundation of the industry and further impacted the TCM research, clinical practice and health insurance reimbursement; and thus led Taiwan’s TCM to evolve into a different system than that of China’s mainland.The purposes of this study are (1) to fill out the cross-strait TC history gap since 1949 with the special emphasis of modernization process under the western scientific influence (2) to provide the basic research backbone and platform for future Taiwan TCM history study in this period.Research Material and Method This thesis adopts the chronological history approach, using the Ming/Chin Dynasty as well as the Japanese colonial occupation period as our reference points, to list the important medical events, persons that make distinguished contribution and their publication and academic achievements from 1949 to the current time and the resulting outcome of the scientific modernization of Taiwan TCM academic research, practice and pharmaceutical products.Methods include:1. Retrospective documentation analysis on the social-economical background and the insight of the scientific content of Taiwan at this time frame using available newspaper reports, autobiography, books.2. Official government records, including government regulation, notification, conference and meeting posters and journal publications, with specific focus on TCM pharmaceutical technique and scientific achievement.3. Case studies on the CTM manufacturing industry, using Sen-Tian-Tung and Shun-Chun as the bench markers, and regulatory agencies, using Department of Health, Bureau of Pharmaceutical Affairs, Committee on Chinese Medicine and Pharmacy, National Laboratory of Food and Drug Analysis and Taiwan Food and Drug Administration as examples, to explore the impact on the Taiwan TCM scientific modernization process.4. Personal interview with oral history recording on living peoples with significant contribution to TCM modernization or with important posts during this period.The above reference materials mainly are from the following databases: Database of Taiwan Modern Medical Artifacts, National Central Library Gatazze Online, Laws and Regulations Database of the Republic of China and CCMP website.Research ResultsThe results consist of three parts and six appendices. The thesis titled "Science and Technology Development History of Taiwan TCM" focuses on the representative persons, Dr. Tu Chun Ming, Dr. Yen Quan Yin and Dr. Hsu Hon Yian, who made the pivotal contributions since the Japanese colonial occupancy period to the late 20 century and set down the foundation for current TCM scientific development, i.e. the scientific status of Taiwan TCM has evolved from the pure lab research project to the evidence-based and clinically acceptable practice with the concentrated TCM pharmaceutical powder dosage form.Part 1.1 reviewed the historical background of Taiwan and collected the past medical information, trend of medical manpower change and exam the evolution of medical history. Taiwanese people encountered the western medicine since the Christian priests came over and started the westernization of medicine. Japanese colonial government brought the medical research and public health concept into Taiwan and established western medical school here. Taiwanese was trained with scientific education either in Taiwan or in Japan and gained social elite positions. On the other hand, the Chinese and Japanese government, during that time, took the side line attitude to the TCM practice without much support. TCM education relied on mentor-disciple training with no systematic academic and research infrastructure.Part 1.2 focused on the pioneers of the scientific modernization development on TCM and the exploratory momentum behind this movement. (1) Dr. TU Tsung Ming (杜聪明), as the first Taiwanese M. D., elicits his influence and insists to teach TCM theory and western/Chinese integrated medical history in National Taiwan University and Kaoshiung Medical College. He also included the Shang-Han-Lun (Treatise on Febrile Diseases,伤寒论), herbal medicine and acupuncture into the medical curriculum. The seed of scientific TCM modernization was implanted under his integrated western/Chinese medicine idealism. (2) Dr. YEN Kun Ying (颜焜荧), the first and the most important executer of TCM scientific researcher and educator, established the manufacturing process and standardization of concentrated TCM powder dosage. It leads the TCM clinical practice into a new milestone. He graduated from Kyoto University with Ph.D. degree in Pharmacognosy. He invented the first new Han prescription "Genseng-Danggui-Shaoyao Powder (人蔘当勺散) " for " Nagakura Medicine Manufacture长仓制药株式会社" with drug license approval from Japanese Department of Health. Using the pharmaceutical technique he developed in Japan, he successfully transferred the know-how to Taiwan Sen-Ten Pharmaceutical Company and established the first standard concentrated TCM powder product. He invented the "Yen’s Kampo Medicine Theory (颜氏汉方理论) " and was twice awarded by Taiwan’s Department of Health with 1st ranking Medical Medal for his contribution to the modernization of TCM in both his academic achievement and industry contribution. (3) Dr. HSU Hong-Yen (许鸿源) was the founder of Sen-Ten-Tung Pharmaceutical Company and also served as Deputy Director of Laboratory of Health of Taiwan Province, the first Director of Bureau of Pharmaceutical Affair and Chair of the Drug Approval Committee of Department of Health in his public service period. He emphasized the importance of quality analysis on the TCM materials and finished products through Bi-An TCM Research Institute which he co-founded with Bristol-Myers Pharmaceutics in late 60s. He promoted the concentrated TCM powder dosage on its merits of convenient use without tedious preparation and reproducible efficacy. Such strategy initiated from Sun Ten Pharmaceutical Co., Ltd. with mouth-to-mouth slogan "Scientific TCM" gained public trust with wide acceptance of this new dosage form. Dr. Hsu was generally recognized as the practitioner of industrialization of "Scientific TCM" Part 1.3 states the development and influence of TCM modernization on the pharmaceutical industry and lists chronological progress of the development of concentrated TCM powder form, its quality analysis, control and assurance, analytical method for quality-indicating ingredients in the raw materials and finished products, clinical trials and new drug research development. (1) TCM Committee Chair of Taiwan Pharmaceutical Manufacturer Association (台湾区制药工业同业公会),Mr. Lee Mu Shi an(李沐勋),introduced the Good Manufacturing Practice (GMP) concept to the TCM manufacturing and conducted the GMP training courses for the industry. He was also the principle investigator of the "Establishment of the Standard TCM Prescriptions (订定中药标准方)”which lay down the foundation of the current "Unified 200 TCM Formulas中药基准方200方)”in Chinese Pharmacopoeia of Chinese Medicine (first edition)(台湾传统药典).(2) All TCM pharmaceutical manufacturers must comply with the regulatory guidance which requires the formulation of concentrated TCM powder products produced according to the "Unified 200 TCM Formulas". This administrative scheme has tremendous impact on the formulation development, manufacture and health insurance reimbursement. It also holds back the willingness for the industry to invest in the new drug R&D. (3) The TCM manufacturer leaders, Sun Ten Pharmaceutical Co. Ltd. and Sheng-Chang Pharmaceutical Co.Ltd., started to make concentrated TCM powder products in 1960s and still are the bench mark models in the industry. There are about 120 GMP TCM manufacturers and approximately 50 of them make concentrated TCM powder products at Jan.1,2011.Part 2 is the appendix of this thesis and consists of documentations from 1949 till now. It separates into six specific chapters, (1) modern standardized TCM manufacturing (2) new drug R&D based on TCM (3) Government agencies responsible for TCM regulation (4) Regulations of TCM (5) Government agencies for TCM research and (6) TCM industry development, and elucidates the linkage of DOH, CCMP, FDA, BNHI and NRICM to the scientific modernization of Taiwan TCM development. New TCM product case studies included the first approved TCM new drug, LipoCol Forte with license number 047152, on 9/30/2005 and the first approved botanical new drug, PhytoHealth PG2 IV Inject able from the extracts of Astragalus membranaceus, on 6/24/2010.The novel viewpoints of this thesis include:(1) systematical collection and recording the historical progress of the scientific development of the Taiwan TCM with original documentation sources (2) overviews on three TCM pioneers, Dr. TU Tsung Ming, Dr. YEN Kun Ying and Dr. Hsu Hon Yian, who made the most significant contribution to the TCM modernization (3) summary on the scientific ideal and academic insight of Taiwan TCM with manufactured product quality standardization, clinical trial, new drug development, GMP implementation, bench mark industry leaders and "Unified 200 TCM Formulas" ConclusionThis thesis adopts the STS (Science, Technology and Science) approach to investigate the scientific modernization process of Taiwan TCM with an attempt to understand the interaction/intervention of the historical background and technology/medical professional achievement during that time frame using the major events and significant people as our study subjects.The major content of this thesis takes the evolution process of the concentrated TCM powder products as the focal assessment indicator to reflect the scientific progress and milestones of TCM in Taiwan. The author has noticed the scientific modernization of TCM not only had considerable academic value but also the practical grass root fruits. The author also analyzed the establishment of TCM research infrastructure and knowledge transfer process from the social and historical need aspect and researcher’s personal academic perseverance and attitude toward science. The meanings of the appearance of Dr. TU Tsung Ming, Dr. YEN Kun Ying and Dr. HSU Hong-Yenas well as the resulting outcome and milestones of concentrated TCM powder finished pharmaceutical products are (1) starting of a new clinical decision making process for TCM clinical practice (2) propaganda of new technology to persuade the general public (3) a dynamic and continuous evolution of Taiwan TCM. During the compilation of the raw data for the Taiwan TCM medical history, the author has accumulated massive unfound documentation before. These data have become the second part of this thesis as the appendices for the future interested researchers to explore.KMT (Kuomintang) government moved to Taiwan in 1949. Taiwan TCM development has gone through a different path than that in China’s mainland. The major achievements include the scientific modernization of TCM pharmaceutical products, reimbursement of TCM diagnosis, treatment and drug payment and TCM based new drug R&D. These achievements, using the western science language that familiar to the international community, have helped other people to understand and appreciate the merits of TCM philosophy, practice and finished products.Sixty years have passed since Taiwan initiated the scientific modernization process of TCM. The heritage of TCM has a unique and diverse meaning and life form in Taiwan than that in China’s mainland. The scientific approach to explore the insight treasure of our ancestors’wisdom will continue. We are all responsible to fully utilize this great asset to fulfill the needs of all human beings. This task shall be our collaborative destiny across Taiwan Strait in this and future generation.更多还原