Toxicological Research

Korean Society of Toxicology & Korea Environmental Mutagen Society (한국독성학회)
권호 표지

Toxicological Evaluation of Chitosan Cross-linked Collagen-GAG Matrix (CCGM) In vitro and In vivo

Chitosan Cross-linked Collagen-GAG Matrix(CCGM)의 독성학적 고찰

  • Lee, Hae-Yul (Research Laboratories, Dong-A Pharm. Co., Ltd.) ;
  • Kim, Dong-Hwan (Research Laboratories, Dong-A Pharm. Co., Ltd.) ;
  • Cho, Hyun (Research Laboratories, Dong-A Pharm. Co., Ltd.) ;
  • Ahn, Byoung-Ok (Research Laboratories, Dong-A Pharm. Co., Ltd.) ;
  • Kang, Soo-Hyung (Research Laboratories, Dong-A Pharm. Co., Ltd.) ;
  • Kim, Won-Bae (Research Laboratories, Dong-A Pharm. Co., Ltd.)
  • Published : 2000.03.01
Download PDF
⟨ Previous Next ⟩

Abstract

Chitosan cross-linked collagen-glycosaminoglyan (CCGM) is an artificial skin substitute made to form a sponge like dimensional matrix. It can be used to facilitate reconstruction of dermal tissue when applied on large wounds such as severe burns. In order to study the toxicological effects of CCGM the cytotoxicity, local irritation and skin sensitization test were carried out according to the standards of ISO 10993. In the cytotoxicity test utilizing LDH and MTT test, both the CCGM and its extract had no toxicity of Balb/c 3T3 cells. The local irritatioin test on rabbit skin demonstrated that CCGM did not promote any harmful when directly applied on skin. In addition, it did not elicit any allergic reaction in the guinea pig maximization test. Based on these results, it is suggested that CCGM is a material without cytotoxicity, local irritation and allergenicity.

Keywords

References

  1. ANSI/AAMI/ISO 10993-5 Tests for cytotoxicity: in vitro methods in Biological Evaluation of Medical Devices Association for the Advancement of Medical Instrumentation (AAMI)
  2. ANSI/AAMI/ISO 10993-10 Tests for irritation and sensitization in Biological Evaluation of Medical Devices Association for the Advancement of Medical Instrumentation (AAMI)
  3. ANSI/AAMI/ISO 10993-12 Sample preparation and reference materials in Biological Evaluation of Medical Devices Association for the Advancement of Medical Instrumentation (AAMI)
  4. Ann. Surg. v.194 Successful use of a physiologically acceptable artificial skin in the treatment of extensive burn injury Burke, J.F.;Yannas, I.V.;Quimby, W.C.;Bondoc, C.;Jung, W.K.
  5. Cancer Res. v.47 Evaluation of a Tetrazolium-based Semiautomated Colorimetric Assay: Assessment of Chemosensitivity Testing Carmicheal, J.;Degraff, W.G.;Gazdar, A.F.;Minna, J.D.;Mitchell, J.B.
  6. United States Patent, Patent Number 5,166,187 Biomaterials with a base of mixtures of collagen. chitosan and glycosaminoglycans, process for preparing them and their application in human medicine Collombel, C.;Damour, O.;Gagnueu, C.;Marichy, I.;Poinsignon, F.
  7. Plast. Reconstr. Surg. v.80 Composite autologous-allogenic skin replacement: development and clinical application Cuono, C. B.;Langdon, R.;Birchall, N.;Barttelbort, S.;McGuire, J.
  8. Annals of the MBC v.1 Controles physicochimiques et experimentaux d'un derme artificiel a base de collagene Damour, O.;Dantzer, E.;Poinsignon, F.;Vescovali, C.;Marichy, J.;Collombel, C.;Echinard, C.
  9. Ann. Chir. Plast. Esthet. v.34 no.4 Development of a non-cellular dermis: a step towards a total artificial skin Damour, O.;Vescovali, C.;David, M.F.;Marchetti, B.;Adhoute, H.;Sahabeddin, L.;Collombel, C.
  10. Biomaterials v.19 Chitosan-chondroitin sulfate and chitosanhyaluronate polyelectrolyte complexes: biological properties Denuziere, A.;Ferrier, D.;Damour, O.;Domard, A.
  11. J. Trauma v.22 The beneficial effects of early excision on clinical response and thymic activity after burn injury Echinard, C.;Sadjel-Sulkowska, E.;Burke, P.A.;Burke, J.F.
  12. J. Allergy v.29 no.5 Experimental toxic and allergic contact dermatitis Fisher, J.P.;Cooke, R.A.
  13. N. Engl. J. Med. v.311 no.7 Permanent coverage of large burn wounds with autologous cultured human epithelium Gallico, G.G. 3rd;O'Connor, N.E.;Compton, C.C.;Kehinde, O.;Green, H.
  14. Am. J. Surg. v.144 no.1 Early surgical excision versus conventional therapy in patients with 20 to 40 percent burns. A comparative study Gary, D.T.;Pine, R.W.;Harnar, T.J.;Marvin, J.A.;Engrav, L.H.;Heimbach, D.M.
  15. Br. J. Plast. Surg. v.45 Closure of the ulnar forearm free flap donor site using a local radial forearm flap Hallock, G.G.
  16. Clin. Plast. Surg. v.25 no.3 Skin replacements Hansbrough, J.M.;Franco. E.S.
  17. Toxicon v.30 no.8 Effect of vchicle on skin penetration and retention of a lipophilic red tide toxin (PbTx-3) Kemppainen, B.W.;Mehta, M.;Stafford, R.;Riley, R.T.
  18. J. Pharm. Pharmacol. v.41 no.2 Topical application of penetration enhancers to the skin of nude mice: a histopathological study Lashmar, U.T.;Hadgraft, J.;Thomas, N.
  19. Int. J. Tiss. Reac. v.ⅩⅣ no.Suppl. Collagen as a pharmacological approach in wound healing Mian, M.;Beghe, F.;Mian, E.
  20. Biomaterials v.9 Biologicaal activity of chitosan: ultrastructural study Muzzarelli, R.;Baldassare, V.;Conti, F.;Ferrara, P.;Biagini, G.
  21. Biomaterials v.10 Rcconstruction of parodontal tissue with chitosan Muzzarelli, R.;Biagini, G.;Pugnaloni, A.;Filippini, O.;Baldassare, V.
  22. Int. J. Tiss. Reac. v.ⅩⅣ no.Suppl. Heterologous collagen in wound healing: a clinical study Palmieri, B.
  23. J. Am. Med. Assoc. v.250 Mortality differences and speed of wound closure among specialized burn car facilities Wolfe, R.A.;Roi, L.D.;Flora, J.D.;Feller, I.;Cornell, R.G.
  24. J. Biomed. Mater. Res. v.14 Design of an artificial skin Yannas, I.;Burke, J.F.
  25. Derm. Beruf. Umwelt. v.31 no.3 Skin irritation by topical drugs Zesch, A.
  26. 국립보건안전연구원보 v.8 인체내 삽입의료용구의 생체내 안전성 평가기준제정을 위한 조사연구 김정구;조대현;김준규;정용;박창원;이윤숙;류종훈;김병대;김부영;문화회
  27. 실험동물사육 및 시험에 관한 표준 작업 지침서(SOP/ANC) 동아제약(주) 연구소
  28. 식품의약품안전청 고시 제 1998-6호 의약품 등의 독성시험기준 식품의약품안전청
  29. 식품의약품안전청 고시 제 1999-13호 의약품 등의 안전성 유효성 심사에 관한 규정 식품의약품안전청
  30. 식품의약품안전청 고시 제 1999-2호 의료용구의 지정등에 관한 규정 식품의약품안전청