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中草藥研發新契機. 抗潰瘍及抗憂鬱中草藥研發案例分享. 柯 逢 年 博士. 財團法人製藥工業技術發展中心 二 OO 二年十月二十五日. 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. 國內外市場及發展趨勢 - I. 國內外市場及發展趨勢 - II.

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slide1

中草藥研發新契機

抗潰瘍及抗憂鬱中草藥研發案例分享

柯 逢 年 博士

財團法人製藥工業技術發展中心

二OO二年十月二十五日

slide2

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

slide4

國內外市場及發展趨勢 - II

1.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.

slide5

西藥(化學合成藥品)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),但新藥(new chemical

entity)核准數並未增加

slide6

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 USD

slide9

對FDA草案的一般認知

?

?

?

文獻記載

人體使用歷史

療效已獲驗證

安全性,毒性無虞

快速進入臨床實驗

縮短臨床實驗流程

產品上市

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 no prior human experience. (from Guidance for Industry Botanical Drug Products)

slide10

The Amount of Information in an IND Submission Depends on :

  • The novelty of the drug
  • The extent to which it has been studied previously
  • The drug products known or suspected risks
  • The development phase of the drug
  • (from Guidance for Industry Botanical Drug Products)
slide11

中草藥研發的助力與阻力

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

傳統中草藥

新興中草藥

理論體系的差異

產品間的差異

嚴謹的臨床試驗

文獻資料

人體使用經驗及歷史

療效

安全性

slide12

Disadvantages of Traditional Chinese Medicines

  • Far from modern sciences
  • Far from controllable
  • Poor standardization
  • Formulation types not accepted
slide15

Research and Development of Herbal Medicine:

a Way from Traditional Chinese Medicine Formulation to

Extract of Single Herb

傳統複方

↓活性導向

加、減方探討

單一藥材

↓活性導向,專利考量

替代藥材

↓品管、配方、製程、活性、毒理

產品

slide18

HPLC Chromatogram

mAU

Standard A

Standard E

150

Standard C

Standard D

100

50

0

0

10

20

30

40

min

150

100

50

0

20

30

40

min

0

10

slide21

Stability Study — Chemical

21

篩選 KoFN 021025

slide22

Target

Primary pharmacodynamics

Pharmacological Studies

Safety Pharmacology

Secondary pharmacodynamics

slide23

Toxicology Studies

單劑量毒性試驗

重覆劑量毒性試驗

生殖毒性試驗

基因突變性試驗

……

slide24

Principles of the TCM Tranquilizers

  • Nourish the heart and tranquilize the mind
  • ( 養心安神 )
  • Clear away heart-fire and tranquilize the mind
  • ( 清心火,定精安神 )
  • Tranquilize the mind, enrich vital energy and blood
  • ( 養心安神,補血益氣 )
  • Nourish the heart, benefit the liver and tranquilize the mind ( 養心益肝,寧心安神 )
  • Tranquilize the mind and disperse the depressed vital
  • ( 安神解鬱 )
slide25

Clinical Uses of the TCM Tranquilizers

  • Palpitation
  • Frightening
  • Irritability
  • Insomnia
  • Dreaminess
  • Amnesia
slide26

安神中草藥的現代研究

 Sedative - Hypnotic

(prolong barbiturate - induced sleeping time)

 Locomotor activity

 Anxiety

 Memory

slide32

Modernization

Science-based

Standardization

品 質

CMC

療 效

Pharmacology

安 全 性

Toxicology

Technology Protection Value

Information for Initial Clinical Studies

Experience–based

Chinese medical

theory guided

New Herbal Medicines

Efficacy

Safety

Quality

32

篩選 KoFN 021025