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1、篩選篩選 KoFN 021025 中草藥研發新契機中草藥研發新契機抗潰瘍及抗憂鬱中草藥研發案例分享抗潰瘍及抗憂鬱中草藥研發案例分享1篩選篩選 KoFN 021025 我國中草藥研發的優勢與契機我國中草藥研發的優勢與契機1.中草藥自成理論體系，非華人不易理解2.國外大廠目前尚未積極介入3.國內已有充分研發基礎與經驗4.充分了解TCM之特點，易與現代疾病關聯，掌握研 發契機5.研發技術較中國領先6.製造技術優良，品質管控亦較中國為佳7.國內由臨床前至臨床研發體系逐步建立並趨完善8.政府全力支持與投入2篩選篩選 KoFN 021025 國內外市場及發展趨勢國內外市場及發展趨勢 - I3篩選篩選 Ko
2、FN 021025 國內外市場及發展趨勢國內外市場及發展趨勢 - II1.WHO Traditional Medicine Strategy 2002-2005, 2002/05.2.WHO 2002/05 report.3.中國中醫藥信息雜誌 2002年4月4. ITIS 2001/12 report.4篩選篩選 KoFN 021025 西藥西藥( (化學合成藥品化學合成藥品) )目前之困境目前之困境1.跨國大藥廠專利逐漸到期2.花費5至8億美金，9至11年才能發展一新藥3.R&D經費每五年增加一倍4.New chemical leads雖增加(1995年5492個； 2000年8191個)
3、，但新藥(new chemical entity)核准數並未增加5篩選篩選 KoFN 021025 R & D Costs of New Chemical Entity and Herbal Medicine * Waive：for products with sufficient human experience and scientific literatures Ref：GloboMax LLC Unit：Thousands of USD6篩選篩選 KoFN 021025 法規面的配合（一）法規面的配合（一）7篩選篩選 KoFN 021025 法規面的配合（二）法規面的配合（二）8篩選篩
4、選 KoFN 021025 對對FDA草案的一般認知草案的一般認知The preclinical pharmacology and toxicology information that should be provided for legally available botanical products with no known safety issues during initial clinical trials may be markedly reduced compared to that expected for synthetic and for which there is
5、no prior human experience. (from Guidance for Industry Botanical Drug Products)文獻記載文獻記載人體使用歷史人體使用歷史療效已獲驗證療效已獲驗證安全性安全性, ,毒性無虞毒性無虞快速進入臨床實驗快速進入臨床實驗縮短臨床實驗流程縮短臨床實驗流程產品上市產品上市?9篩選篩選 KoFN 021025 The Amount of Information in an IND Submission Depends on :b The novelty of the drugb The extent to which it has
6、been studied previouslyb The drug products known or suspected risksb The development phase of the drug(from Guidance for Industry Botanical Drug Products)10篩選篩選 KoFN 021025 中草藥研發的助力與阻力中草藥研發的助力與阻力傳統中草藥新興中草藥文獻資料人體使用經驗及歷史理論體系的差異產品間的差異嚴謹的臨床試驗Raw material的管控CMC的技術難度 化學及療效一致性的驗證 安定性的證明 藥動學的研究智財權的保護療效安全性11
7、篩選篩選 KoFN 021025 Disadvantages of Traditional Chinese Medicines=Far from modern sciences=Far from controllable=Poor standardization=Formulation types not accepted12篩選篩選 KoFN 021025 13篩選篩選 KoFN 021025 14篩選篩選 KoFN 021025 傳統複方傳統複方 活性導向活性導向加、減方探討加、減方探討 單一藥材單一藥材 活性導向，專利考量活性導向，專利考量替代藥材替代藥材 品管、配方、製程、活性、毒理品
8、管、配方、製程、活性、毒理 產品產品Research and Development of Herbal Medicine：a Way from Traditional Chinese Medicine Formulation to Extract of Single Herb15篩選篩選 KoFN 021025 Control of Raw Material 16篩選篩選 KoFN 021025 Control of Raw Material II17篩選篩選 KoFN 021025 HPLC ChromatogramStandard AStandard EStandard CStandar
9、d D0100501500103040min200103040min20010050150mAU18篩選篩選 KoFN 021025 Specifications of Drug Substance1819篩選篩選 KoFN 021025 Specification of Drug Product1920篩選篩選 KoFN 021025 21Stability Study Chemical21篩選篩選 KoFN 021025 Pharmacological StudiesSecondary pharmacodynamicsSafety PharmacologyTargetPrimary pha
10、rmacodynamics22篩選篩選 KoFN 021025 Toxicology Studies單劑量毒性試驗單劑量毒性試驗重覆劑量毒性試驗重覆劑量毒性試驗生殖毒性試驗生殖毒性試驗基因突變性試驗基因突變性試驗23篩選篩選 KoFN 021025 =Nourish the heart and tranquilize the mind= ( 養心安神養心安神 )=Clear away heart-fire and tranquilize the mind = ( 清心火清心火,定精安神定精安神 )=Tranquilize the mind, enrich vital energy and bl
11、ood = ( 養心安神養心安神,補血益氣補血益氣 )=Nourish the heart, benefit the liver and tranquilize the mind ( 養心益肝養心益肝,寧心安神寧心安神 )=Tranquilize the mind and disperse the depressed vital= ( 安神解鬱安神解鬱 )Principles of the TCM Tranquilizers24篩選篩選 KoFN 021025 Clinical Uses of the TCM TranquilizersbInsomniabDreaminessbAmnesiab
12、PalpitationbFrighteningbIrritability25篩選篩選 KoFN 021025 安神中草藥的現代研究安神中草藥的現代研究 Sedative - Hypnotic (prolong barbiturate - induced sleeping time) Locomotor activity Anxiety Memory26篩選篩選 KoFN 021025 Effects of Extract and Imipramine on TBZ-Induced Hypothermia27篩選篩選 KoFN 021025 HPLC分析分析-I-I28篩選篩選 KoFN 021
13、025 HPLC分析分析-II-II29篩選篩選 KoFN 021025 Norepinephrine, Dopamine and SerotoninUptake Assay - I30篩選篩選 KoFN 021025 Norepinephrine, Dopamine and SerotoninUptake Assay - II31ModernizationScience-basedStandardization品 質CMC療 效Pharmacology安 全 性ToxicologyInformation for Initial Clinical StudiesTechnology Protection ValueExperiencebasedChinese medicaltheory guidedNew Herbal MedicinesEfficacySafetyQuality篩選篩選 KoFN 021025 3232
