小肠粘膜下层组织工程支架材料的生物相容性研究

目的 观察小肠粘膜下层(SIS)的生物相容性和作为组织工程支架材料的可行性.方法 参照国际标准ISO10993-1制定的医疗器械生物学评价的相关方法和标准,通过细胞毒性试验、热原试验、溶血试验、致敏试验、肌肉刺激试验等体内外生物学实验相结合的方法评价SIS的生物相容性及免疫原性.结果 实验证明小肠粘膜下层细胞相容性良好,不溶血,无致热、致敏反应,肌肉刺激试验的组织学检查见SIS周围无明显炎症及排斥反应,材料部分降解并见大量结缔组织生长.结论 SIS具有良好的生物相容性和免疫原性,可作为组织工程的支架材料.

Study Of The Biocompatibility Of Small Intestinal Submucosa (SIS) As Scaffold For Tissue Engineering

Objective To investigate the biocompatibility and feasibility of small intestinal submucosa (SIS) as a scaffold for tissue engineering. Methods According to the related methods of and criterion of ISO 10993-1 to evaluate bio-materials. The tests in vitro and in vivo including cytotoxicity, haemolysis test, hypersensitive test, pyrogen test and muscle stimulate test were employed to evaluate the biocompatibility. Results All the above tests had proved that the SIS had no cytotoxicity and do not cause haemolysis, pyrogen, hyperergia or inflammatory and antialien response. Conclusion SIS has excellent biocompatibility and can be used as a good scaffold for tissue engineering.