초록 ▼

1. 기준 및 시험법
▶ 유효 성분조사를 통해 포도종자추출물(Catechin), 포공영(Caffeic acid), 오미자(Schizandrin)을 표준물질로 선정 후 HPLC 동시정량 분석법 개발 및 검증(Method validation)
2. 지표물질 안정성 평가
▶ 6개월간 가족, 정기시험을 통하여 지표물질의 안정성을 입증함
3. In-vivo test를 통한 천연물의 간장보호 효능검색
▶ CCl4 유도 간독성, GaIN 유도 간염, ANIT 유도 담즙 울체, Ethionine 유도 지방간 결과를 종합

1. 기준 및 시험법
▶ 유효 성분조사를 통해 포도종자추출물(Catechin), 포공영(Caffeic acid), 오미자(Schizandrin)을 표준물질로 선정 후 HPLC 동시정량 분석법 개발 및 검증(Method validation)
2. 지표물질 안정성 평가
▶ 6개월간 가족, 정기시험을 통하여 지표물질의 안정성을 입증함
3. In-vivo test를 통한 천연물의 간장보호 효능검색
▶ CCl4 유도 간독성, GaIN 유도 간염, ANIT 유도 담즙 울체, Ethionine 유도 지방간 결과를 종합하여 볼때 HV-P411은 간염, 담즙울체 및 지방간에서 간보호 효과를 나타내는 것으로 판단됨
4. 시제품제작
▶ 시제품제작 완료
5. 임상시험
▶ 피험자모집 완료

Abstract ▼

I. The purpose and necessity of research and development
▶ AS Currently republic of Korea most common liver disease will die 40s.
Liver diseases representative of the republic of Korea, and cited as cause of death are important in the world.
▶ A large number of liver diseases in the world b

I. The purpose and necessity of research and development
▶ AS Currently republic of Korea most common liver disease will die 40s.
Liver diseases representative of the republic of Korea, and cited as cause of death are important in the world.
▶ A large number of liver diseases in the world being studied. but In-reality, reliable, effective for improving the liver and the development of functional foods that Is not being done.
▶ Therefore, this task through the raw material selection standards for the active ingredient, assay validation, stability indicator material, In-vivo and human tests by conducting research on liver damage that can be effective in improving liver function natural products are developed to improve the health food.
II. Content and scope of research and development
1.Prototype manufacturing
2.Establishcriteriaandtestmethods
3.Evaluationofstandardsstability
4.In-vivotestoftheliverprotectiveeffectsthroughthenaturalsearch
5.ClinicalTrial
6.Healthfood permit
7.Formulationselectionandprototypemanufacturing
III. Study Results
1. Prototype manufacturing
▶ dried Schisandra, taraxacum herb screening made the purchase after → Distilled 10 multiples 60 <TEX>${^{\circ}C}$</TEX>, 5 hours after the extraction → filtration vacuum freeze-dried concentrated → mixed
2. Establish criteria and test methods
▶ investigation, the active ingredient in grape seed extract: Catechin, Taraxacum herb: Caffeic acid. Schisandra: Schizandrin selected as the standard material
▶ the development of grape seed extract, Taraxacum herb, Schisandra for specificity, accuracy, precision, honesty lines secured simultaneous HPLC assay and validation (Method Validation)
3. Evaluation of standards stability
▶ During 6 month. acceleration test and long-term retention test by proving the stability of the standard.
4. In-vivo test, over the natural products of liver protection efficacy results
▶ CCl4 induced hepatotoxicity, GaIN induced hepatitis, ANIT induced cholestasis, Ethionine induced liver HV-P411 judging by the results of a comprehensive hepatitis, cholestasis and liver protective effects in the liver is considered to be representing.
5. Clinical Trial
5.1.Progress
5.1.1. Seoul St. Mary's Hospital
Period: 2009.01~2010.04
Screening: 57
Screening failure: 49
Completion: 8
*Be eliminated rate of SCreening 86%. subject selection and exclusion criteria for selection of subjects difficult.
to improve entry rate of clinicalt rial participants this institution(St Vincent's Hospital). known to add across roads.
5.1.2. St. Vincent's Hospital
Period: 2010.05.~2011.01
Screening: 88
failure: 7
Ongoing: 28
Drop out: 12
Completion: 42
*January 21, 2011 Last subject property, the point of observed when taking the test products is after 3months
5.2. hereafter schedule
Clinical trials: ~ 2011.04
Statistics analysis: finished Clinical trials ~ 2011.05
The resulting report: finished Clinical trials ~ 2011.06
6. Health food permit
▶ health supplements based on the experimental results of written approval documents
▶ July 2011, approval documents will be accepted
7. Formulation selection and prototype manufacturing
▶ making a trial product in capsule form
IV. Utilization of research results
1. To market
▶ objective, reliable scientific studies based on individual improvement in liver health food market is structured
▶ its home shopping sales rise in domestic sales of products using
▶ its export sales to the foreign exchange market by acquiring overseas
2. Generating employment, the sector
▶ The health functional food sales first year, than the release of 3 billion won in second year, 50 billion and 90 billion estimated in third year
▶ When seated on the market as expected, headquarters, manufacturing plants, domestic marketing, international marketing, and creating more employment, at least 20 people

목차 Contents

• 표지 ... 1
• 목차 ... 4
• I. 총괄현황 ... 6
• 1. 제출문 ... 8
• 2. 보고서요약서 ... 9
• 3. 요약문(한글) ... 10
• 4. 요약문(영문) ... 13
• 5. 연구 성과 실적 및 향후 계획 ... 16
• 6. 참여연구원 현황표 ... 20
• II. 총괄연구과제 연구결과 ... 22
• 1. 연구개발과제의 배경 및 필요성 ... 24
• 2. 국내외 기술개발 현황 ... 26
• 3. 연구개발과제의 추진체계 ... 28
• 4. 연구개발수행 내용 및 결과 ... 31
• 5. 목표달성도 및 관련분야 기여도 ... 47
• 6. 향후 연구성과 추진계획 ... 49
• 7. 연구개발결과의 파급효과 ... 50
• 8. 연구개발결과의 활용계획 ... 52
• III. 제1세부 연구과제 연구결과 ... 56
• 1. 연구개발과제의 목표 ... 58
• 2. 연구개발과제의 추진체계 ... 59
• 3. 연구개발수행 내용 및 결과 ... 61
• 4. 참고문헌 ... 115
• IV. 제2세부 연구과제 연구결과 ... 116
• 1. 연구개발과제의 목표 ... 118
• 2. 연구개발과제의 추진체계 ... 118
• 3. 연구개발수행 내용 및 결과 ... 119
• 4. 참고문헌 ... 143
• V. 첨부서류 ... 146
• 1. 자체평가의견서 ... 148
• 2. 실적 증빙자료 ... 153
• 끝페이지 ... 162