[Biological evaluation of artificial skin substitute].
Multiple kinds of Artificial Skin Substitute are now available. However, except for the Homo Skin Graft there is no Artificial Skin Substitute that can be used as permanent Artificial Skin Substitute. During the past 20 years, more and more scholars around the world have expressed increased interests in the research and development of Artificial Skin Graft that can be utilized as satisfying permanent Artificial Skin Substitute. We conducted our research on the biological evaluation of medical devices of Collagen-Chitosan(C-C) Artificial Skin Substitute according to the National Standard (GB/T16886. 1-1997). The following experiments were conducted: (1)Cytotoxicity, (2)Systemic toxicity(acute toxicity), (3)Haemocompatibility, (4)Sensitization, (5)Intracutaneous reactivity, (6)Pyrogen test, (7)Genotoxicity. The experiment results demonstrate that all biological functional indexes of the Artificial Skin Graft meet the National Standards. Therefore, we conclude that C-C Artificial Skin Graft is characteristic of good biological compatibility. It is non-irritant and has no systemic and cellular toxicity, no genotoxicity, no pyrogen, and no allergen.
Jiang
Hua
H
Tianjin Institute of Medical and Pharmaceutical Science, Tianjin 300070, China.
Jia
Wenying
W
Zhu
Junmei
J
Liu
Xin
X
Nie
Wei
W
Cheng
Lin
L
Shi
Hongdao
H
Deng
Shilin
S
D000818:Animals; D048271:Chitosan / Q000633:toxicity*; D003094:Collagen / Q000633:toxicity*; D005260:Female; D008297:Male; D008422:Materials Testing; D051379:Mice; D011897:Random Allocation; D017768:Skin, Artificial / Q000009:adverse effects*
D003094:Collagen; D048271:Chitosan