초록 ▼

- 감초를 Novozyme 33095로 처리했을 때 함량이 증가하는 리퀴리티 게닌을 기능성분으로 설정하고 최적 효소처리조건을 확립하였음.
- 기능성분의 분석법을 확립하고 밸리데이션을 수행하였으며, 효소분해감초추출물의 제조공정을 표준화하였음.
- 시제품에 대한 in vivo, in vitro 실험을 통해 기능성분 및 효소분해 감초추출물의 인지기능개선 효과를 확인하였음
- 인체적용시험용 위약, 진약을 제조하고 IRB 심의를 거친 후 임상 시험을 수행하였음.
- 섭취근거, 섭취량 정보, 공인시험성적서 등 개별인정신청

- 감초를 Novozyme 33095로 처리했을 때 함량이 증가하는 리퀴리티 게닌을 기능성분으로 설정하고 최적 효소처리조건을 확립하였음.
- 기능성분의 분석법을 확립하고 밸리데이션을 수행하였으며, 효소분해감초추출물의 제조공정을 표준화하였음.
- 시제품에 대한 in vivo, in vitro 실험을 통해 기능성분 및 효소분해 감초추출물의 인지기능개선 효과를 확인하였음
- 인체적용시험용 위약, 진약을 제조하고 IRB 심의를 거친 후 임상 시험을 수행하였음.
- 섭취근거, 섭취량 정보, 공인시험성적서 등 개별인정신청에 필요한 제반 요건을 충실히 준비하였음.
- 결론적으로 인체적용시험의 결과, 통계학적으로 유의미한 인지기능개선효과를 나타내지 못하여 개별인정 신청에 이르지는 못하였으나 기억력 감퇴정도가 심한 그룹에서는 주목할 만한 결과가 도출되어 추후 인체적용시험 대상자 수를 늘리고 복용량을 조절하여 2차 인체적용시험을 수행할 계획임

(출처 : 보고서 요약서 3p)

Abstract ▼

Purpose&Contents
Development of health functional food for improvement of cognition/memory by fermentation of Glycyrrhizae Radix for increasing in liquiritigenin content

○ Optimization of fermentation conditions for poruducing liquiritigenin
○ Standardization of fermentation procedure

Purpose&Contents
Development of health functional food for improvement of cognition/memory by fermentation of Glycyrrhizae Radix for increasing in liquiritigenin content

○ Optimization of fermentation conditions for poruducing liquiritigenin
○ Standardization of fermentation procedure
○ Clinical test for approval as a functional food from KFDA
○ Request of approval as a functional food to KTDA

Results
1. Sub-project 1: Standardization of manufacturing fermented GR
▪ Collecting informations about GR
- Qunatification of 8 representative constituents in GR
- Discrimination methods amomg similar GR species

▪ Development of quantification method for liquiritigenin (LQ)
- Provide evidences that LQ is appropriate as a standard
- Synthesis and isolation of LQ
- Development of HPLC quantification and validation for LQ
- Establishment of SOP and limitation of LQ contents (200 μg/g)

▪ Establishment of manufacturing procedures
- Refluxing GR with 10 times of 50% ethanol for 5 h, the cooling to 30℃, the add enzyme 200 mL/kg GR for 12 h.
Addition of x4 dextrin and spray dried
- SOP and specification of materials used in manufacturing
- Declaration of enzyme degraded GR as food items

▪ Additional evidences of GR for memory enhancing fuction
- Neuroprotective effect of LQ Phase 1 metabolites
- Preventive effect of LQ in APPswe-N2a on A-beta production

▪ Clinical test
- Dose determination and its background: 1g/day
- Manufacturing capsules for clinical test(placebo and authentic, ca 45,000 capsules)
- Preparation and submission of investigator’s broshure: IRB approval
- Recruiting 8 trials, 72 persons completed the clinical test
- No significant relationship was found, however, relatively severe memory deficient trials showed efficacy worthy of notice. We are planning to try 2^nd clinical trial.

▪ Documentation for approval from KFDA
- Comletion of documentation for submission
- Because of negative clinical result, after completion of 2^nd clinical test, the decision will be made whether we submit the documents to KFDA or not

Expected Contribution
1. The increasing in the income of farmers by development of high quality functional products using Korean Glycyrrhizae Radix
2. The enhancement of public health by development of health functional food for improvement of cognition and memory

(출처 : Summary 5p)