새로운 식물성에스트로겐 특허기술의 표준화, 추가 기능성 자료 확보 및 SERM 효능 연구;제1세부과제명: 새로운 식물성에스트로겐의 제조공정 및 제품 표준화연구;제2세부과제명: 새로운 식물성에스트로겐의 추가 유효성 확보 및 SERM 효능 연구 Standardization, additional evaluation activity and SERM effect of new proprietary phytoestrogen원문보기
o 백수오 등 복합추출물(FGF-271)의 구성 원료인 백수오, 속단, 당귀의 지표성분을 기존의 연구자료를 바탕으로 각각 cinnamic acid, shanzhiside methylester, decursin으로 선정하였음. o Cinnamic acid와 shanzhiside methylester에 대해 분석법을 개발하였고 개발한 분석법에 대해 밸리데이션 수행. o 백수오등 복합추출물 시제품의 지표성분을 분석하여 제품의 표준화를 수행 o 백수오 등 복합추출물의 여성호르몬 활성을 확인하기 위한 in vitro 실험결과
o 백수오 등 복합추출물(FGF-271)의 구성 원료인 백수오, 속단, 당귀의 지표성분을 기존의 연구자료를 바탕으로 각각 cinnamic acid, shanzhiside methylester, decursin으로 선정하였음. o Cinnamic acid와 shanzhiside methylester에 대해 분석법을 개발하였고 개발한 분석법에 대해 밸리데이션 수행. o 백수오등 복합추출물 시제품의 지표성분을 분석하여 제품의 표준화를 수행 o 백수오 등 복합추출물의 여성호르몬 활성을 확인하기 위한 in vitro 실험결과 MCF-7 cell에서 세포증식 억제효과를 확인함. o Ishikawa cell과 SaOS-2 cell에서 각 생약추출물에 비해 복합추출물이 두 가지 세포주 모두에 대해 높은 ALP induction 활성을 가짐을 확인하였다. o 난소절제동물에서는 자궁의 증대 없이 femoral BMD가 절제대조군 대비 치료군에서 유의하게 상승하여 난소절제 쥐에서 골 대사를 개선시킴을 확인함. o ER ${\alpha},\;{\beta}$에 대한 affinity 실험은 현재까지 유의한 결과를 얻지 못함. o 3개월 반복투여실험에서는 독성이 없음. o 이상의 결과로 식약청 개별인정형 원료/성분으로 신청함.
Abstract▼
I. Need and object of this project Pre-, peri-, and post-menopausal women will constitute 43.2% oft otal Korean women and the number will be 11.3 million in 2030 from 5.2 million in 2000 in Korea. It means that most of korean women will live one third of their lives as postmenopausal state and th
I. Need and object of this project Pre-, peri-, and post-menopausal women will constitute 43.2% oft otal Korean women and the number will be 11.3 million in 2030 from 5.2 million in 2000 in Korea. It means that most of korean women will live one third of their lives as postmenopausal state and they will experience decrease of quality of life and increase of economic burden because of menpausal syndrome such as dangerous osteoporosis, hot flush, night sweat, urine inconsistency, vaginal dryness, vaginal dystrophy, atherosclerosis and other CVD. Based on WHI investigation on HRT, FDA banned a long-term prescription of HRT for menpausal syndrome due to the increased risk of breast cancer, heart attack, and stroke. The efficacy and safety of such existing phytoestrogen as isoflavone and black cohosh is at scientific criticism. In the previous studies, we screened plants from edible sources for amelioration or prevention of menopausal syndrome. As a result, we developed the formula of Cynanchum wilfordii, Angelica gigas, and Phlomis umbrosa (FGF271) and perofomed arandomized double-blind placebo-controlled human clinical study with 48 women fort rear to find out that FGF271 relieved climacteric symptoms and BMD significantly. The results of this Project will be bundled with the existing scientific evidences to be submitted to KFDA as a new functional food material for the claim of "it can help improve menopausal symptoms and health of climacteric women". II. Detailed research 1. Standardization of FGF271 1) Selection of standard compounds and development of analysis method of them 2) Validation of the analysis methods 3) Test production and standardization 2. Function of FGF271 to PMS and its mechanism study 1) Estrogenic actions of FGF271 on the MCF-7 cells, Ishikawa cells and SaOS-2 cells. 2) In vivo estrogenic and osteogenic action with ovariectomized rat model 3) Toxicity test : 3 months of repeated oral administration 4) Affinity of FGF271 for ER ${\alpha},\;{\beta}$ III. Results We selected cinnamic acid, shanzhiside methylester and decursin as standard compounds for C. wilfordii, P. umbrosa and A. gigas, respectively. The analysis methods for cinnamic acid and shanzhiside methylester were developed. And the two methods are validated to be proper for the quantification of the two standards in specimens. With these two methods and a method in Korean Pharmacopeia on decursin, standardization of FGF271 has been set up. FGF271 was found to inhibit the proliferation of MCF-7 cells. In Ishikawa and SaOS-2 cells, FGF271 was effective to induce ALP as phytoestrogen. In vivo study with ovariectomized animal model, there was not any uterus growth but significantly improved femoral BMD in FGF271 feeding group. On the ER binding assay, we did not get any significant result. No toxicity was recognized after 3 month toxicity test. IV. Further research With the results of this research, we applied FGF271 to KFDA as a new functional food material. But a few data were requested by KFDA and we are preparing them. Also we applied for GRAS to US FDA. As a dietary supplement, we exported FGF271 (In a name of EstroG100) to US and we plan to launch to EU and middle east.
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