止血防粘连生物纸的生物相容性研究

止血防粘连生物纸是一种采用天然多糖交链制成的新型可降解止血防粘连材料，具有纤维蛋白原活性增强作用和吸水后呈水凝胶结构起到隔离防粘连作用。本研究采用GB／T16886医疗器械生物学评价标准规定的全身急性毒性试验、皮内刺激试验、致敏试验、细胞毒性试验、植入试验和基因毒性试验方法评价生物纸的生物相容性，以验证其安全性和有效性。试验结果显示生物纸无全身急性毒性、无皮内刺激作用、无致敏作用，细胞毒性0～1级；植入肌肉内2周、4周和8周有轻度炎症反应，可见异物巨细胞，细胞内可见材料吞噬体；基因毒性采用鼠伤寒沙门氏菌回复突变试验（Ames试验），哺乳动物培养细胞染色体畸变试验和小鼠骨髓嗜多染红细胞微核试验均为阴性，说明生物纸无基因毒性。结论：生物纸具有良好的生物相容性，没有观察到不良反应，符合临床使用要求。

Biocompatibility Investigation of Haemostatic and Anti-adhesive Biopaper

Biopaper is a newly developed biomaterial with haemostatic and anti-adhesive activity. This new polysaccharide derived material enhances the fibrinogen clottability for haemostatic action and becomes hydrogel as a separation barrier after contacting with body liquid for anti-adhesion. We studied the biopaper biocompatibility using the acute systemic toxicity, subcutaneous reactivity, sensitization, cytotoxicity, intramuscular implantation and genotoxicity rests described in GB/T16886. The experimental results showed that the biopaper has no acute systemic reaction, no subcutaneous reactivity, no sensitization, cytotoxicity score 0- 1 grade, slight inflammatory reaction with foreign body giant cells observed after 2.4 and 8 weeks implantation. The negative results of Ames test and mammalian cell chromosome aberration as well as micronucleus test demonstrated the biopaper has no genotoxicity. It is concluded that the biopaper has excellent bioeompatibility and meet the requirement for clinical application.