Abstract ▼

1. Evaluation of in vivo efficacy and establishment of optimal application method
A. Alleviation of the immune and hematopoiesis suppression in the gamma-irradiated animal model
B. Alleviation of the immune and hematopoiesis suppression in the anticancer drug(cyclophosphamide)-treated animal m

1. Evaluation of in vivo efficacy and establishment of optimal application method
A. Alleviation of the immune and hematopoiesis suppression in the gamma-irradiated animal model
B. Alleviation of the immune and hematopoiesis suppression in the anticancer drug(cyclophosphamide)-treated animal model
C. Promotion of the anti-cancer immune responses
D. Reduction of in vivo oxidative damage
2. Establishment of standards for active component content and optimal production method
A. Analysis of general ingredients (polysaccharide, protein, sugar content) and establishment of standards
B. Identification of active components and designation of the indicator components
C. Analysis of active component content and setting up the standards
D. Establishment of the optimal production method
E. Establishment of optimal manufacturing process
F. Enhancement of efficacy by RT and MCT
G. Toxic material (heavy metals and residual pesticides) content analysis
3. Evaluation of biosafety in long-term administration, teragenicity and local toxicity
A. Evaluation of safety in long-term administration in an animal model
B. Evaluation of teratogenicity and local toxicity in animal models
4. Clinical evaluation of developed product for recovery of immune system in the treatment of cancer patients
* Evaluation of clinical efficacy of a pilot product (HemoHIM) in cancer patients who received radiotherapy and chemotherapy.
A. Study patients
- Patients with breast cancer, uterine cervix cancer, head and neck cancer
B. Administration of pilot product to study patients
- The selected study subjects were classified 2 groups with or without HemoHIM intake among cancer patients received radiotherapy and chemotherapy.
C. Evaluation of clinical efficacy of pilot product in study patients
- The clinical efficacy of pilot product (HemoHIM) on recovery from hematopoiesis damage was evaluated in cancer patients who received radiotherapy and chemotherapy.
5. Human study of the herbal preparation(HemoHIM) on enhancement of immune and hematopoietic functions
A. Subjects
- Sub-healthy volunteers with peripheral blood WBC count lower than 5000/μl.
B. Experimental groups and administration
- This study was conduced as a double-blind, placebo-controlled human study.
- Subjects were randomly allocated to placebo group, HemoHIM 6g/day group, and HemoHIM 12g/day group.
- Each subject was administered with placebo or HemoHIM for 4 months after the pre-test.
C. Evaluation of the improving effects on immune and hematopoietic functions, and antioxidant biomarkers
- Peripheral blood was collected 4 times (before administration, 1/2/4 month(s) after administration).
- Hematological values and serum biochemical values were determined.
- Immunological functions of isolated lymphocytes were examined.
- Antioxidant biomarkers of plasma were measured.

목차 Contents

• 제 1 장 연구개발과제의 개요...35
• 제 2 장 국내$\cdot$외 기술개발 현황...37
• 제 3 장 연구개발수행 내용 및 결과...39
• 제 1 절 시작품의 생체최적 적용기술 개발...39
• 1. 연구 범위 및 내용...39
• 2. 연구 내용 및 방법...39
• 3. 연구결과 및 고찰...45
• 제 2 절 시작품의 유효성분 기준 설정 및 최적 생산공정 확립...61
• 1. 연구범위 및 내용...61
• 2. 연구 내용 및 방법...61
• 3. 연구결과 및 고찰...65
• 제 3 절 시작품의 장기간 섭취$\cdot$최기형성 및 국소독성에 대한 안전성 평가...82
• 1. 연구 범위 및 내용...82
• 2. 연구내용 및 방법...83
• 3. 연구결과 및 고찰...89
• 제 4 절 시작품의 암환자에서 면역조혈장해 회복증진 임상효용성 평가...111
• 1. 연구범위 및 내용...111
• 2. 연구내용 및 방법...111
• 3. 연구결과 및 고찰...113
• 제 5 절 시작품(헤모힘)의 면역조혈 개선 인체시험 평가...128
• 1. 연구범위 및 내용...128
• 2. 연구내용 및 방법...128
• 3. 연구결과 및 고찰...133
• 제 4 장 연구개발 목표 달성도 및 대외 기여도...151
• 1. 연구개발 목표의 달성도 ...151
• 2. 대외 기여도 ...153
• 제 5 장 연구개발결과의 활용 계획...154
• 제 6 장 연구개발과정에서 수집한 해외 과학기술정보...155
• 제 7 장 참고문헌...157
• 부 록 ...159