초록 ▼

□ 과제명 : 백수오 등 복합추출물의 여성갱년기 증상개선 효능에 대한 다기관인체임상연구
▶ 연구목적 : 백수오 등 복합추출물의 글로벌 시장에서의 경쟁력 확보를 위해 국제적 수준의 연구자료 확보
○ 밸리데이션된 효능평가 지표를 활용한 다기관 인체임상시험을 완료하여 경쟁소재와 대비하여 안전하면서도 뛰어난 효능을 재확인
○ 우수한 원재료의 안정적 공급을 위한 생약자원연구
○ 효율적인 품질평가를 위한 신규지표물질 발굴 및 분석법 확립
▶ 주요연구내용 :
○ 1세부과제명 : 백수오 등 복합추출물의 여성갱년기

□ 과제명 : 백수오 등 복합추출물의 여성갱년기 증상개선 효능에 대한 다기관인체임상연구
▶ 연구목적 : 백수오 등 복합추출물의 글로벌 시장에서의 경쟁력 확보를 위해 국제적 수준의 연구자료 확보
○ 밸리데이션된 효능평가 지표를 활용한 다기관 인체임상시험을 완료하여 경쟁소재와 대비하여 안전하면서도 뛰어난 효능을 재확인
○ 우수한 원재료의 안정적 공급을 위한 생약자원연구
○ 효율적인 품질평가를 위한 신규지표물질 발굴 및 분석법 확립
▶ 주요연구내용 :
○ 1세부과제명 : 백수오 등 복합추출물의 여성갱년기 증상개선 효능에 대한 다기관임상연구 : 생약특성 및 백수오 추가 지표물질 탐색
- 인체임상을 통해 우수한 여성갱년기 증상개선효과 확인
: KMI와 세부증상 9가지, 추가지표인 질건조증 등 총 10가지 증상을 유의하게 개선 확인
: 이상반응, 임상병리검사를 통해 시험물질에 의한 부작용이 없음을 확인하였으며 또한 여성호르몬 관련 E2 및 FSH 수치에도 변화가 없음을 재확인
- 우수한 원재료의 안정적 공급을 위한 생약자원연구
: 세 가지 생약의 국내자원수집, 백수오의 성공적 계약재배 지원
: 백수오 이엽우피소 구별 동정 및 백수오 표본 확보
- 효율적인 품질평가를 위한 신규지표물질 발굴 및 분석법 확립
: 백수오, 한속단, 참당귀 분석 프로파일 확보 – 백수오, 한속단 신규지표성분을 이용한 동시분석법 확립 및 밸리데이션
: 백수오 등 복합추출물의 효능기작연구를 위한 유전자발현 및 GPCR 효능연구
○ 2세부과제명 : 백수오 등 복합추출물의 여성갱년기 증상개선 효능에 대한 다기관임상 연구 : 무작위 이중맹검 위약대조 임상연구
- 인체임상을 통해 우수한 여성갱년기 증상개선효과 확인
: KMI와 세부증상 9가지, 추가지표인 질건조증 등 총 10가지 증상을 유의하게 개선 확인
: 이상반응, 임상병리검사를 통해 시험물질에 의한 부작용이 없음을 확인하였으며 또한 여성호르몬 관련 E2 및 FSH 수치에도 변화가 없음을 재확인

Abstract ▼

Ⅰ. Purpose
Although there is big market potential of 10 billion dollars in the global menopausal market, it is not easily achieved due to issues of toxicity and weak efficacies of HRT, black cohosh, and soy isoflavones. EstroG-100, safely manufactured from food materials has been proved for its g

Ⅰ. Purpose
Although there is big market potential of 10 billion dollars in the global menopausal market, it is not easily achieved due to issues of toxicity and weak efficacies of HRT, black cohosh, and soy isoflavones. EstroG-100, safely manufactured from food materials has been proved for its good efficacies and safety with 2 human clinical trials and in vivo/toxicity tests. But the EstroG-100 has only 2 clinical trials compared to its competitors, and there is a need to supply enough raw herb, Cynanchum wilfordii. In this project we tried to strengthen its scientific evidences with a more credible multi-center clinical trial and MOA study, and to establish supply capacity of raw materials.
Ⅱ. Research and results
1. Establishment of raw material supply
- Domestic natural and cultivated resources of three herbs were searched, and samples were collected then analysed. We studied and got profiles of major chemicals in the herbs with HPLC DAD detector. Most of main peaks were identified with standard chemicals.
- Discrimination methods with TLC and PCR of C. wilfordii and C. auriculatum was successfully developed, and these methods are now being used for QC in the manufacturing process of EstroG-100.
- Contract cultivation of C. wilfordii was very successful. Now it is possible to supply C. wilfordii for worldwide demand on the EstroG-100.
2. Multi-center clinical trial 105 peri-, post menopausal women were enrolled at three university hospitals of each Ajou University, Yeonsei Unversity and Korea University.
This multi-center clinical trial was performed double-blind, randomized with 514mg of EstroG-100 and placebo by a CRO. After 12 weeks of administration, we got significant improvement of Kupperman Index(KMI) and its 8 detailed symptoms and vaginal dryness too.
3. Tests for further MOA study
There are not sufficient scientific studies on the effect of estrogen on hot flash or for other herbs used for menopausal symptoms. We should search for most suspicious targets in brain and bone. Cell lines from brain and bone were selected, and mRNA expression were studied and compared by treatment of estradiol or EstroG-100. Additionally, the effect of EstroG-100 on 60 selected G protein-coupled receptors(GPCR) were studied as well.
EstroG-100 has high agonist activities on 2 GPCR receptors.
Ⅲ. Conclusions and further researches
As result of this project, we have enough supply of C. wilfordii for global demand, and the cultivated herb is used in manufacture. Results on Phlomis umbrosa would be used for cultivation of this herb whose supply depends on collection recently. HPLC profiles of three herbs and C. wilfordii identification data can be submitted as basic data and evidence of proper quality control of EstroG-100 for global approvals for health supplements. PCR methods is now being used for quality control in the EstroG-100 production.
Results of multi-center clinical trial are made good use for the marketing in those previously approved countries, US and Canada, etc, and will be for the approvals in other countries.
We are going to study MOA with the 2 GPCR agonist activities on hot flash of menopausal women and search new target from untested GPCRs and nuclear receptors. Data from mRNA expressions of 2 cell lines are under analysis for better improved studies.