Historical Research On Traditional Chinese Medicine Scientification In Taiwan

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 mainland China 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 Mainland China.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 Mainland China. 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 Mainland China. 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.