新型淀粉基止血材料的制备及生物相容性研究

Fabrication and Biocompatibility Investigation of a Novel Hemostatic Material

以马铃薯淀粉为主要原料,同时添加少量透明质酸和三偏磷酸钠并通过冷冻干燥技术制备一种新型淀粉基止血材料。利用电子显微镜观察其微观结构,用XRD测定其晶体结构,用DSC测定其热稳定性,同时还根据国家标准GB/T16886医疗器械生物学评价标准对其进行生物相容性研究。研究结果表明,此新型淀粉基止血材料呈现三维网络状结构,交联反应发生在非晶区且具有良好的热稳定性。动物实验表明该材料无皮内刺激反应、无致敏、无全身急性毒性及细胞毒性,具有良好的生物相容性。结果表明:该新型淀粉基止血材料在临床应用上具有广阔的前景。

The novel hemostatic material was fabricated from starch,hyaluronic acid and STMP with freeze -drying technique. The microstructure,crystalline structure and thermal stability of the material were studied by SEM,XRD and DSC respectively.And the biocompatibility of this material was investigated by subcutaneous reactivity,sensitization,acute systemic toxicity and cytotoxicity tests described in GB/T16886.The results showed that the crosslinking reaction occurred in amorphous area and this novel hemostatic material presented three -dimensional network structure which was of favourable thermal stability.Animal experiments indicated that the material had no subcutaneous reactivity,no sensitization,no acute systemic reaction and no cytotoxicity.It is concluded that this novel hemostatic material shows promise for clinical applications.