보고서 정보
주관연구기관 |
퓨리메드(주) Purimed Co.Ltd |
연구책임자 |
강문규
|
참여연구자 |
고성규
|
보고서유형 | 최종보고서 |
발행국가 | 대한민국 |
언어 |
한국어
|
발행년월 | 2007-05 |
과제시작연도 |
2006 |
주관부처 |
보건복지부 |
사업 관리 기관 |
한국보건산업진흥원 Korea Health Industry Development Institute |
등록번호 |
TRKO200900000271 |
과제고유번호 |
1460004775 |
사업명 |
보건의료기술연구개발(기금) |
DB 구축일자 |
2013-04-18
|
키워드 |
임상시험.기능성 식품.혈당조절.상엽.지각.Clinical trial.Functional food.control of blood glucose.Folium Mori.Aurantii Fructus.
|
초록
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PURIAM110(지각과 상엽 복합물)렌 대한 기준 및 규격을 정립하였고 Steptozotocin으로 당뇨를 유발한 SD rat 제1형 인슐린 의존성 당뇨병 모델과 유전적비만으로 당뇨를 유발한 OLETO rat제2형 인슐린 비의존성당뇨병 모델을 이용하여 PURIAM110에 의한 유의성 있는 혈당조절 효과 및 당뇨로 인해 나타나는 여러 가지 현상들(몸무게 감소, 음식섭취량증가, 소변량증가)에 대한 유의성 있는 해소효과를 확인하였음. 제대정맥내피세포를 통한 실험에서 steptozotocin에 의해 감소된 생존율을 PURIAM110 투여
PURIAM110(지각과 상엽 복합물)렌 대한 기준 및 규격을 정립하였고 Steptozotocin으로 당뇨를 유발한 SD rat 제1형 인슐린 의존성 당뇨병 모델과 유전적비만으로 당뇨를 유발한 OLETO rat제2형 인슐린 비의존성당뇨병 모델을 이용하여 PURIAM110에 의한 유의성 있는 혈당조절 효과 및 당뇨로 인해 나타나는 여러 가지 현상들(몸무게 감소, 음식섭취량증가, 소변량증가)에 대한 유의성 있는 해소효과를 확인하였음. 제대정맥내피세포를 통한 실험에서 steptozotocin에 의해 감소된 생존율을 PURIAM110 투여에 의해 생존율이 유의성 있게 증가하였고 대동액 부전현상을 유의성 있게 회복시켰음. PURIAM110 투여군에서, 4개의 단백질이 유의성 있게 증가하였음. 랫드에서의 최소치사량은 5,000 mg/kg을 상회하는 아주 안전한 물질로 밝혀짐. 당뇨병경계의 환자들 총 50명을 대상으로 6주간의 이중맹검, 무작위 배정, 위약비교, 다기관 시험(경희대학교한방병원, 경원대서울한방병원, 경원대인천한방병원)으로 진행되었음. 인체시험결과, LDL-cholesterol 및 OGTT, Fructosamine 수치가 PURIAM110군에서 복용전과 6주복용후 유의성 있게 감소하였음.
Abstract
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1. Manufacture of clinical trial functional food: PURIAM110
Cinical trial functional foods were manufactured as a type of 500 mg hard capsule composed of sprayed-dry powder from water boiling extracts of Aurantii Fructus and Mori Folium in ratio of one to one.
2. Studies of PURIAM110`s effect
1. Manufacture of clinical trial functional food: PURIAM110
Cinical trial functional foods were manufactured as a type of 500 mg hard capsule composed of sprayed-dry powder from water boiling extracts of Aurantii Fructus and Mori Folium in ratio of one to one.
2. Studies of PURIAM110`s effect and its mechanism on anti-diabetes using in vivo and in vitro system
Anti-diabetes effects of PURIAM110 were measured using streptozotocin-induced diabetes rat and genetically modified obesity rat, OLETO rat. Administration of PURIAM110 reduced significantly blood glucose in both models and the blood glucose after 2hrs of glucose administration, OGTT, oral glucose tolerance test in OLETO rat model. Also, it or Aurantii Fructus or Mori Folium, resolved significantly reduced body weight, increased food intake and urine volume attributed to diabetes in both models or the other model. Aurantii Fructus recovered significantly reduced contractile dysfunction of ischemic and reperfufed rat heart model and in vivo ischemia model using ligation of LAD. In vitro experiments, PURIAM110 or Aurantii Fructus or Mori Folium significantly recovered reduced viability of HUVECs induced by streptozotocin. Also, they significantly recovered dysfunction of aorta in streptozotocin-induced diabetes rat. PURIAM110 significantly increased expressions of myosin heavy chain, cytokeratin 8 polypeptide, Chymotrypsinogen B and amylase 1 in pancreas of streptozotocin-induced diabetes rat.
3. Standardization of PURIAM110 and establishment of quality control system
Appropriate raw materials of herbal medicines were chosen fitted to standards through tests for heavy metals, agrichemicals and standard materials in them. Afterwards, chosen materials were extracted by boiling water, concentrated and splayed-dry, resulting in form of powder in the help of Sun Ten Pharmaceutical company, Taiwan.
4. Studies of active ingredients or standard materials of PURIAM110
Standard material of Aurantii Fructus was chosen as hesperidine and standard material of Mori Folium was chosen as $0.69{\pm}0.09mg\;(0.07{\pm}0.01%)$ and 1-deoxynojirimycin $4.98{\pm}0.14mg\;(0.50{\pm}0.01%)$ in PURIAM110.
5. Standardization and maximizing manufacture process of PURIAM110 requested by KFDA
Materials and capsules of PURIAM110 matched to standards of KFDA standardization tests.
Single dose administration test for PURIAM110 was performed in CamOn. In result, PURIAM110 is proved to be a safe one over 5,000 mg/kg of MLD(Minimum Lethal Dose). Manufacturing process for materials of PURIAM110 was maximized by Sun Ten Pharmaceutical company, Taiwan.
6. Phase II clinical trial of PURIAM110
Phase II clinical trial of PURIAM110 was performed for 60 patients in boundary of diabetes for 6 weeks in double-blinded, randomized, placebo-controlled and multiple centers. In result of clinical trial, LDL-cholesterol and blood glucose of OGTT were significantly reduced in PURIAM110 treatment group for 6 weeks, compared to start. in the other hand, fructosamine, an major indication of diabetes, a glycoprotein was significantly reduced in PURIAM110 treatment group for 6 weeks, compared to start and piacebo treatment group for 6 weeks.
7. Application of PURIAM110 as an individually approved functional food for modulation of blood glucose on KFDA.
PURIAM110 will be applied as an individually approved functional food for modulation of blood glucose on KFDA based on sum of pre-described results with report of clinical trial for PURIAM110 coming on end of May, results of stability tests, long-term storage test and accelerated condition storage test for 6 months and repeated dose administration test on rodent coming soon.
목차 Contents
- II. 총괄연구과제 연구결과...32
- 1. 연구개발과제의 배경 및 필요성...34
- 2. 국내외 기술개발 현황...38
- 3. 연구개발과제의 추진체계...42
- 4. 연구개발수행 내용 및 결과...43
- 5. 목표달성도 및 관련분야 기여도...45
- 6. 향후 연구성과 추진계획...47
- 7. 연구개발결과의 파급효과...47
- 8. 연구개발결과의 활용계획...51
- 9. 연구개발과정에서 수집한 해외과학기술정보...54
- 10. 참고문헌...56
- III. 제 1 세부연구과제 연구결과...57
- 1. 연구개발과제의 목표...58
- 2. 연구개발과제의 추진체계...63
- 3. 연구개발과제의 내용 및 결과...66
- 4. 참고문헌...246
- IV. 제 2 세부연구과제 연구결과...253
- 1. 연구개발과제의 목표...254
- 2. 연구개발과제의 추진체계...254
- 3. 연구개발과제의 내용 및 결과...259
- 4. 참고문헌...276
- V. 첨부서류...280
- 1. 자체평가의견서...281
- 2. 연구성과 실적 증빙서류...287
- 3. 기타 요청서류...287
- 양식 3. 최종보고서 비공개 승인요청...296
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