초록 ▼

골관절염 치료제 (WIN-34B)에 대하여 6차년도 및 7차년도(기간연장)에서는 상기 처방의 제품화를 위하여 아래와 같은 연구를 진행함.
- 계속적인 전임상 연구 수행
- 약효/일반약리/기전연구 (연골보호, 연골재생, 진통, 항염, 면역 연구)
- 규격화/표준화 연구를 통한 기준 및 시험방법 확립
- WIN-34B 정제 및 과립제의 제제, 제형 및 안정성 연구
- 생산공정 연구를 통한 대량생산 및 임상 원료 확보
- WIN-34B 정제 및 과립제의 임상승인계획서 준비 및 승인
- 2상 임상연구

골관절염 치료제 (WIN-34B)에 대하여 6차년도 및 7차년도(기간연장)에서는 상기 처방의 제품화를 위하여 아래와 같은 연구를 진행함.
- 계속적인 전임상 연구 수행
- 약효/일반약리/기전연구 (연골보호, 연골재생, 진통, 항염, 면역 연구)
- 규격화/표준화 연구를 통한 기준 및 시험방법 확립
- WIN-34B 정제 및 과립제의 제제, 제형 및 안정성 연구
- 생산공정 연구를 통한 대량생산 및 임상 원료 확보
- WIN-34B 정제 및 과립제의 임상승인계획서 준비 및 승인
- 2상 임상연구 진입
- 지적/재산권 확보

Abstract ▼

I. Background
Osteoarthritic disorders have increased with the aging society in the 21st century and has become increasingly problematic, and the WHO has declared the decade starting from 2000 to be a bone & joint decade and is focusing research and support in that direction. The current modaliti

I. Background
Osteoarthritic disorders have increased with the aging society in the 21st century and has become increasingly problematic, and the WHO has declared the decade starting from 2000 to be a bone & joint decade and is focusing research and support in that direction. The current modalities of treatment for osteoarthritic disorders have limited treatment effects and accompany a range of side effects, and new treatment methods are needed. The medications frequently used for osteoarthritic disorders have systemic side effects such as indigestion, gastrointestinal tract problems, renal function loss and weakened immunity and these occur more frequently in elderly patients.
Therefore, development of new medications which have better treatment effects, less side effects, and treat the diseases fundamentally is needed. Our center wishes to develop a new medication based on the final compound(WIN-34B), and has conducted research on the chondroprotective, analgesic, and antiinflamatory effects, mechanism of action, standardization, drug forms, pre-clinical research, and clinical research in an effort to produce a novel Traditional Oriental medication with minimal side effects and maximal treatment effects.
II. Details and range of research
200 candidate herbs were screened from the initial screening process based on review of traditional Oriental medical prescriptions from China, Japan, and Korea, folk prescriptions, and related literature including various clinical papers and reports. 42 were selected for further investigation. During the 1st research period, herbs with proven efficacy were further researched for anti-inflammatory, analgesic, chondroprotective, regenerative, immunotonic, bone metabolism affecting, osteosynthetic, and bone repairing effects and related mechanisms in an effort to develop a single-herbal or combined prescription with good therapeutic effects on degenerative arthritis, rheumatic arthritis, and osteoporosis and bone damage. Based on the results, select prescriptions were fractionated using organic solvents and the efficacies of these in in vitro and in vivo models were researched. During the 2nd research period, the center chose a final candidate prescription for osteoarthritic diseases(OAH-19B) with the result of the evaluation of the 1st stage. But toxicity was found during testing of OAH-19B, and we failed to remove the causative agent without losing efficacy. A new prescription was chosen (OAH-34B) after re-evaluation of the research database. Efficacy testing in animal models with osteoarthritis, research on mass production, standardization, drug form and pre-clinical research lead us to choose this as the final prescription for development (renamed WIN-34B). The preparation of a clinical research protocol and IND acceptance has allowed us to start 2nd phase clinical testing at the 6th year (WIN-34B tablet preparation). Our center extended the research period for 1 year to work on development of WIN-34B as a Traditional Oriental medicine preparation for use in osteoarthritis. Research on drug form of the WIN-34B granule, development of a Traditional Oriental medical clinical research guideline in osteoarthritis, and IND accepted (WIN-34B granule form).
III. Result
The novel Traditional Korean medication for osteoarthritis(WIN-34B) has finished development. It has minimal side effects and can be taken for prolonged periods, has chondroprotective and chondrogenetic effects which are not currently available in conventional medications, and has superior anti-inflammatory and analgesic effects compared to Celecoxib and Joins, which are representative medications currently used in clinical practice in osteoarthritis.
IV. Plans for application
If clinical trials produce meaningful results, we plan to attain a product license for osteoarthritis and plan to enter the market on 2013 emphasizing the difference between our medication and conventional products.

목차 Contents

• 1. 표지 ...1
• 2. 제출문 ...3
• 목차 ...4
• I. 총괄현황 ...6
• 3. 보고서 요약서 ...7
• 4. 요약문(한글) ...8
• 5. 요약문(영문) ...10
• 6. 연구성과 실적 및 향후 계획 ...12
• 7. 참여연구원 현황표 ...30
• II. 총괄연구과제 연구결과 ...32
• 1. 연구개발과제의 배경 및 필요성 ...33
• 2. 국내외 기술개발 현황 ...34
• 3. 연구개발과제의 추진체계 ...35
• 4. 연구개발수행 내용 및 결과 ...41
• 5. 목표달성도 및 관련분야 기여도 ...50
• 6. 향후 연구성과 추진 계획 ...53
• 7. 연구개발결과의 파급효과 ...54
• 8. 연구개발결과의 활용계획 ...55
• 9. 연구개발과정에서 수집한 해외과학기술정보 ...60
• II-1. 제 1 세부 연구과제 ...63
• 1. 연구개발과제의 목표 ...64
• 2. 연구개발과제의 추진체계 ...65
• 3. 연구개발과제의 내용 및 결과 ...67
• 4. 참고문헌 ...159
• II-2. 제 2 세부 연구과제 ...166
• 1. 연구개발과제의 목표 ...167
• 2. 연구개발과제의 추진체계 ...169
• 3. 연구개발과제의 내용 및 결과 ...171
• 4. 참고문헌 ...212
• II-3. 제 4 세부 연구과제 ...216
• 1. 연구개발과제의 목표 ...217
• 2. 연구개발과제의 추진체계 ...217
• 3. 연구개발과제의 내용 및 결과 ...219
• 4. 참고문헌 ...321
• III. 첨부서류 ...325
• 목차...326
• 1. 자체평가의견서 ...327
• 2. 실적 증빙자료 ...331
• 3. 기타 첨부서류 ...340