C-C创面覆盖物生物学评价研究

Biological Evaluation of Artificial Skin Substitute

目前已有多种烧伤创面覆盖物,但除自体皮移植以外,还没有一种覆盖物能作为永久性创面覆盖物。近20年来,开发和研究各种创面覆盖物并使之最终成为令人满意的永久性人体皮肤替代物已日益引起国内外学者的关注。依据国家标准(GB/T 16886.1-1997)对医疗器械生物学评价的要求,我们对胶原-壳聚糖(C-C)创面覆盖物选择(1)细胞毒性试验;(2)急性全身毒性试验;(3)溶血试验;(4)皮肤致敏试验;(5)原发性皮肤刺激试验;(6)热原试验;(7)遗传毒性试验,进行生物学安全性评价研究。结果显示:C-C创面覆盖物的各项生物学性能指标全部符合国家标准要求,具有良好的生物相容性,无全身毒性和细胞毒性,无热源性、致敏性、刺激性,也无遗传毒性,是一种生物相容性优良的C-C创面覆盖物。

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.