화학공학소재연구정보센터
홈 로그인 로그아웃 연락처 사이트맵
Polymer(Korea), Vol.40, No.2, 225-231, March, 2016
DOI10.7317/pk.2016.40.2.225  Export Citation
생체재료로서 적용을 위한 폴리케톤의 생물학적 안전성 평가
Biological Safety Evaluation of Polyketones as Biomaterials
이미희1, 2, 이대형1, 2, 백현숙3, 권병주1, 2, 구민아1, 2, 김민성1, 2, 선경미1, 2, 박종철1, 2, †
  • 1연세대학교 의과대학 의학공학교실 세포제어연구실
  • 2세브란스병원 의료기술품질평가센터
  • 3세브란스병원 의료기술품질평가센터 Brain Korea 21 PLUS Project
Mi Hee Lee1, 2, Dae-Hyung Lee1, 2, Hyun-Sook Baek2, Byeong-Ju Kwon1, 2, Min-Ah Koo1, 2, Min Sung Kim1, 2, Gyeung Mi Seon1, 2, and Jong-Chul Park1, 2, †
  • 1Cellbiocontrol Laboratory, Department of Medical Engineering, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea
  • 2Medical Technology and Quality Evaluation Center, Severance Hospital, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, Korea
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초록
생체재료는 의료기기로서 임상에 적용되기 위해서는 생물학적 안전성 평가에 의한 생체적합성 확보가 필수적이다. 이번 연구에서는 폴리케톤 고분자의 생체재료로서 사용 가능성을 평가하기 위해 생물학적 안전성 평가를 실시하였다. 폴리케톤 고분자의 용출물로 고분자의 생체적합성을 판단하는 생물학적 안전성 초기실험인 세포독성, 유전독성, 피부자극성, 감작성, 전신독성 시험을 실행하였다. 모든 시험에서 폴리케톤 고분자는 독성을 유발하지 않음을 확인할 수 있었으며, 이러한 결과는 폴리케톤 고분자가 생체재료로서 생물학적 안전성이 있으며 비분해성 고분자를 대체할 수 있을 것으로 판단된다.
Biomaterials for clinical applications such as medical and implant devices require evaluation to determine their biocompatibility. This study aimed to evaluate the initial biological safety of polyketone (PK) polymers, which have potential use as biomaterials. It presents results from cytotoxicity and genotoxicity assays and tests determining the levels of skin irritation, sensitization, and acute systemic toxicity caused by PK. The PK polymers showed no cytotoxicity, genotoxicity, allergenicity, irritancy, and systemic toxicity. These results indicate that the PK polymers are potentially biological safe and could be used to replace non-degradable polymeric biomaterials.
Keywords:polyketones;biomaterials;biocompatibility;biological safety
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