보고서 정보
주관연구기관 |
대전대학교 산학협력단 Daejeon University |
보고서유형 | 최종보고서 |
발행국가 | 대한민국 |
언어 |
한국어
|
발행년월 | 2015-07 |
과제시작연도 |
2014 |
주관부처 |
보건복지부 [Ministry of Health & Welfare(MW)(MW) |
등록번호 |
TRKO201600004456 |
과제고유번호 |
1465015808 |
사업명 |
한의약선도기술개발 |
DB 구축일자 |
2016-08-20
|
키워드 |
아토피 피부염.전임상시험.한약제제.임상시험승인.atopic dermatitis.GST.preclinical trial.Korean medicine.IND.
|
DOI |
https://doi.org/10.23000/TRKO201600004456 |
초록
▼
- 설치류 단회/4주반복/13주반복 경구투여 독성시험, 유전독성시험, 비설치류 단회 경구투여 용량증가 독성시험에서 GST의 최대내성용량이 5,000 mg/kg 이상으로 확인.
- 변증설문지(ADPIQ)와 평가도구로서 POEM-K를 제작하고 IRB 승인 후 아토피 피부염 환자를 대상으로 신뢰도와 타당도를 확인함.
- 임상시험계획서 “ 아토피 피부염 환자를 대상으로 GST정의 안전성 및 유효성을 탐색적으로 평가하기 위한 무작위배정, 양측눈가림, 위약 대조, 평행, 용량 결정, 2상 임상시험” 을 작성함
- NC/Nga
- 설치류 단회/4주반복/13주반복 경구투여 독성시험, 유전독성시험, 비설치류 단회 경구투여 용량증가 독성시험에서 GST의 최대내성용량이 5,000 mg/kg 이상으로 확인.
- 변증설문지(ADPIQ)와 평가도구로서 POEM-K를 제작하고 IRB 승인 후 아토피 피부염 환자를 대상으로 신뢰도와 타당도를 확인함.
- 임상시험계획서 “ 아토피 피부염 환자를 대상으로 GST정의 안전성 및 유효성을 탐색적으로 평가하기 위한 무작위배정, 양측눈가림, 위약 대조, 평행, 용량 결정, 2상 임상시험” 을 작성함
- NC/Nga atopic dermatitis 모델, Ovalbumin 유발 알레르기 모델, Passive sensitized 마우스 모델에서 GST 효능을 확인함.
- 원료의약품 규격과 제조공정을 수립하고 기준 및 시험방법을 확립하였으며 시제품을 제작함
- GST의 fingerprint로서 isoorientin, vitexin, nodakenin, apigenin-7-glucoside, decursin을 확인.
- GST의 장기보존 시험으로 확인시험, 중금속시험, 제제균일성시험, 미생물한도시험, 붕해시험, 함량시험(당귀 중 노다케인 0.40mg 이상)에서 기준에 적합하였음.
Abstract
▼
Ⅰ. Background and purpose
This study aimed to development oral medication based on oriental medicine as possible long term and systemic using.
Atopic dermatitis prevalence rate is rapidly increasing. Atopic dermatitis causes restriction of daily activities and social life but it is difficult t
Ⅰ. Background and purpose
This study aimed to development oral medication based on oriental medicine as possible long term and systemic using.
Atopic dermatitis prevalence rate is rapidly increasing. Atopic dermatitis causes restriction of daily activities and social life but it is difficult to radical therapy.
Ⅱ. Contents and range
Securing safety of GST
Securing effectiveness of GST as Anti atopic dermatitis
Development of dosage form, foundation of standardizing, confirmation of stability
Development of clinical trial protocol for GST as atopic-dermatitis and permission (IND) for clinial trail
Ⅲ. Development result
-To evaluate the GST safety studies were done treated with single oral dose, 4 weeks repeated oral dose, 13 weeks repeated oral dose toxicity test and 4 weeks recovery test, reverse mutation test, chromosome aberration test, micronucleus test, and Single Oral Dose-increasing Toxicity Test. The Maximum Tolerated Dose is 5000 mg/kg.
-Make questionnaires(ADPIQ and POEM-K) and check reliability and validity in patient of atopic dermatitis.
-To evaluate safety and effectiveness of GST clinical trial protocol of patients for atopic dermatitis was prepare for a randomized, double-dummy, placebo controlled, parallel-group, Phase Ⅱ Clinical Trial.
-GST was effective to improving of dermatitis in NC/Nga atopic dermatitis model. GST decresed dermatitis score, frequency of scratch, inflammation cells, IgE, immune cells, cytokines.
-GST decresed inflammation cells, total IgE, OVA-specific IgE, immun cells, cytokines in allergic model by Ovalbumin
-GST decresed ear swelling of mouse and dermis of expansion to swelling in Passive sensitized mouse model.
-Producing experimental product base on foundation of material medicine standard and manufacturing process and testing method.
-Check isoorientin, vitexin, nodakenin, apigenin-7-glucoside, decursin on in HPLC/PDA chemical fingerprintig condition as fingerprint of GST
-Fitted guideline as verification test, heavy metals limit test, microbial limit test, disintegration test, contest test on examination of preservation conservation test in GST.
Ⅳ. Planning of development result
Progress clinical trial in the GST as anti-atopic dermatitis
Provide base of clinical research in Korean medicine as anti-atopic dermatitis
Atopic dermatitis diagnosis system is using various clinical research
Using as basic data of development on new medicine and dosage form in anti atopic-dermatitis
Strengthen capability through objectivity of Korean medicine in contribute to national health
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