초록 ▼

본 과제에서는 안전성이 입증된 생약 천연물 식품소재의 추출물을 대상으로 베타카테닌 신호활성을 유도하는 후보군을 도출하고 이를 이용해서 탈모예방 활성을 지닌 양모 기능성 스킨케어 제품화 개발을 위한 연구를 진행하였다. 비임상 효력시험을 통하여 최종 소재를 선정하여 독성시험을 완료하였으며, 개발소재의 품질관리설정 및 표준화를 통하여 시제품 제형결정 및 개발제품의 안정성시험을 진행하였다. 또한 간이 인체적용시험을 통해 홍반, 가피, 부종 등의 부작용이 확인되지 않아 안전한 소재임을 재확인하였다.
추가적으로 피부투과율을 높일 수 있는

본 과제에서는 안전성이 입증된 생약 천연물 식품소재의 추출물을 대상으로 베타카테닌 신호활성을 유도하는 후보군을 도출하고 이를 이용해서 탈모예방 활성을 지닌 양모 기능성 스킨케어 제품화 개발을 위한 연구를 진행하였다. 비임상 효력시험을 통하여 최종 소재를 선정하여 독성시험을 완료하였으며, 개발소재의 품질관리설정 및 표준화를 통하여 시제품 제형결정 및 개발제품의 안정성시험을 진행하였다. 또한 간이 인체적용시험을 통해 홍반, 가피, 부종 등의 부작용이 확인되지 않아 안전한 소재임을 재확인하였다.
추가적으로 피부투과율을 높일 수 있는 피부투과 촉진 인핸서를 개발하여 제조공정을 구축하고 국제 화장품 원료집 (INCI)에 등재 하였다.
개발소재의 용도특허출원 및 학술지 발표를 통하여 과학적 근거자료를 마련하였다.

(출처 : 보고서 요약서)

Abstract ▼

Results
Ingredients allowed as food ingredient were searched, and 211 candidates of herbal medicine ingredients were screened and extracted for evaluation. To evaluate the efficacy of the screened ingredients, efficacy evaluation of Wnt/b-catenin signaling activation and 5α-reductase inhibition w

Results
Ingredients allowed as food ingredient were searched, and 211 candidates of herbal medicine ingredients were screened and extracted for evaluation. To evaluate the efficacy of the screened ingredients, efficacy evaluation of Wnt/b-catenin signaling activation and 5α-reductase inhibition were studied in vitro.
Ingredients with superior efficacy were selected, and related reference and patents were reviewed to select 4 candidates with higher potential for development of hair growth enhancing material (Agastachis Herba, Eucommiae Cortex, Rhei Rhizoma, Nardostachyos Rhizoma).

1. Establishment of quality control standard and standardization
(1) Selection of herbal medicine ingredient / sample preparation for in vitro efficacy evaluation
- Screening and selection of herbal medicine ingredients based on the ingredients allowed to be used as food and other quasi-drugs for alopecia prevention
- Establishment and evaluation of Wnt/β-catenin signaling activity stimulation enhancement
- Establishment and evaluation of 5α reductase inhibition activity
- Selection of 4 herbal medicine ingredients with high potential for development (Agastachis Herba, Eucommiae Cortex, Rhei Rhizoma, and Nardostachyos Rhizoma)
- Final selection of Rhei Rhizoma and Nardostachyos Rhizoma for production of sample products after evaluating the extracts and fractions of 4 herbal medicine ingredients by in vitro and in vivo studies

(2) Sample product commercialization and development of utilization technology
- Establishment of optimal extraction conditions for mixed extract of Rhei Rhizoma and Nardostachyos Rhizoma.
- Scale-up production of the mixed extract of Rhei Rhizoma and Nardostachyos Rhizoma
- Establishment of quality control standards for the mixed extract of Rhei Rhizoma and Nardostaachyos Rhizoma
- Establishment of optimal conditions for the best color, odor, and transparency with low precipitation
- Design for easy use in liquid form by spraying on the scalp

2. Formulation selection and stability data of sample product (regulatory documents)
(1) Preparation of CMC documents for product development
- Preparation of documents for safety and efficacy evaluation based on
‘Regulation on registration, evaluation, and approval of quasi-drug products’
- Preparation of documents for ingredient and finished product about physicochemistry, manufacturing documents, establishment of specifications and safety control

(2) CMC Package for product development
- Manufacture of sample product and implementation of skin sensitization test and toxicity test
- Establishment of Specifications for quality control and stability of ingredient and finished product
- Establishment of manufacturing process, selection of marker compounds, analytical method validation, specifications, and stability study

(3) Stability study of ingredient and finished product
- Stability test of real-time condition (25±5℃, 60±5% RH) and accelerated condition (40±5℃, 75±5% RH)
- No significant change in marker compounds in the ingredient (up to 15 months) and the finished product (up to 6 months)
- Establishment of storage condition and expiry of the ingredient and the finished product from the stability study database

3. Completion of non-clinical efficacy and toxicity studies
(1) Preliminary efficacy study for trandermal absorption candidate formulation
- Evaluation of 1st and 2nd efficacy pre-test on animals (rodents) with single or mixed extracts of Agastachis Herba, Eucommiae Cortex, Rhei Rhizoma, and Nardostachyos Rhizoma
- Selection of final ingredients of Rhei Rhizoma and Nardostachyos Rhizoma with highest efficacy on hair growth efficacy testing

(2) Non-clinical toxicity study
- Completion of single-dose toxicity study with transdermal administration on SD-Rat
- Completion of 2-week repeated-dose toxicity study (DRF) with transdermal administration on SD-Rat
- Completion of local toxicity study – eye irritation test
- Completion of local toxicity study – skin irritation test
- Completion of 4-week repeated-dose toxicity study and 2-week recovery study on SD-Rat
- Completion of skin sensitization test (Buehler method) on Hartley guine pigs
- Completion of bacterial reverse mutation test
- Completion of chromosomal aberration test on mammalian cultured cells
- Completion of pre-clinical study

4. Skin penetrating stimulation enhancer
(1) Manufacture and property study of skin penetrating stimulation conjugate enhancer
- Establishment of manufacturing line of conjugate enhancer for increased transdermal penetrating rate
- Development of conjugate enhancer of chitooligosaccharide (COD, ferulic acid, and fatty acid (COS-phenol- fatty acid)
- Establishment of qualitative and quantitative analytical methods
- Evaluation of physical property by transdermal penetrating test
- Evaluation of antibiotic effects of the compounds in conjugation enhancer

(2) Property study of enhancer
- Evaluation of conjugate enhancer, chitooligosaccharide (COS) - fatty acid(PUFA)
- Evaluation of conjugate enhancer, chitooligosaccharide (COS) - ferulic compound (OA) - fatty acid (PUFA)
- Evaluation of optical absorption of final conjugation enhancer

(3) Establishment of manufacturing process of conjugate enhancer
- Establishment of manufacturing process of conjugation enhancer by manufacturing threesome by adding chitooligosaccharide (COS) to twosome of ferulic acid and fatty acid with high antioxidant activity
- Confirmation of conjugation by HPLC-RP analysis of each procedure
- Manufacture and evaluation of ferulic acid-fatty acid (twosome)
- Manufacture and evaluation of chitooligosaccharide-ferulic acid-fatty acid(threesome)
- Purification of chitooligosaccharide-ferulic acid-fatty acid (threesome)

(4) Formulation study of trandermal absorption of mixed extract of herbal medicine
- Establishment of the concentration of the mixed extract of Rhei Rhizoma and Nardostachyos Rhizoma and the concentration of ethanol
- Formulation and evaluation by matrix
- Evaluation of other hair growth enhancing compounds and spray pattern
- Evaluation of odor masking from sensory evaluation of menthol and other flavoring additives.

(5) Registration of enhancer material (technology) in INCI
- Registration of INCI name (Hydrolyzed Chitosan Ferulyl Linoleate) and trade name (NE-201) in PCPC(personal care products council)
- Easy searching by registering in the International Cosmetic Ingredient Dictionary and Hand book, wINCI (web-based Dictionary wINCI), INFOBASE (the Council’s On-Line INFOBASE)

5. Utility patent application and journal publication of developed material
- Patent : 7 Applications, 1 registration
- Publication : 2 publications in process
- Advertisement : 3 presentations at conferences

(출처 : SUMMARY)

목차 Contents

• 표지 ... 1제출문 ... 2보고서 요약서 ... 3국문 요약문 ... 4SUMMARY ... 8Contents ... 14목차 ... 151.연구개발과제의 개요 ... 16 1-1. 연구개발 목적 ... 16 1-2. 연구개발의 필요성 ... 16 1-3. 연구개발 범위 ... 192.국내외 기술개발 현황 ... 20 2-1. 국내 탈모 시장의 규모 및 성장성 ... 20 2-2. 해외 탈모시장의 규모 및 성장성 ... 203.연구수행 내용 및 결과 ... 22 3-1. 후보 생약선정 및 개발 후보군 (추출물) 도출 ... 22 3-2 비임상시험 및 허가자료 준비 ... 56 3-3. 피부투과 촉진 인핸서 개발 ... 75 3.4 홍보 전시 (성과) ... 884.목표달성도 및 관련분야의 기여도 ... 91 4-1. 목표 달성도 ... 91 4-2. 관련분야 기여도 ... 915.연구결과의 활용계획 ... 926.연구과정에서 수집한 해외과학기술정보 ... 927.연구개발결과의 보안등급 ... 928.국가과학기술종합정보시스템에 등록한 연구시설·장비 현황 ... 929.연구개발과제 수행에 따른 연구실 등의 안전조치 이행실적 ... 9310.연구개발과제의 대표적 연구실적 ... 9411.기타사항 ... 9412.참고문헌 ... 95별첨1 연구개발보고서 초록 ... 97끝페이지 ... 99