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目的研究海藻酸盐敷料的止血性能,并初步探究其生物相容性。方法采用凝血指数试验测定体外凝血性能。采用新西兰兔耳和背部创伤止血试验测定止血性能。采用溶血试验和细胞毒性试验进行初步安全性评价。结果海藻酸盐敷料、明胶海绵的凝血指数BCI分别为33.1±4.9、72.0±3.3,海藻酸盐敷料凝血效果优于明胶海绵。在背部创伤出血模型中,海藻酸盐敷料、明胶海绵、纱布的平均止血时间为(55.3±5.1)s、(80.2±7.4)s、(101±14.7)s,Hb光度吸收值分别为1.5±0.7、2.5±0.5、3.8±0.7。与明胶海绵比较,海藻酸盐敷料的平均止血时间缩短了31.05%,Hb光度吸收值降低了40.00%;与纱布比较,海藻酸盐敷料的平均止血时间缩短了45.25%,Hb光度吸收值降低了60.53%。在兔耳动脉止血实验中,海藻酸盐敷料、明胶海绵、纱布的出血量分别为(2.4±0.2)g、(3.0±0.2)g、(3.9±0.2)g,止血时间分别为(226.3±6.5)s、(332.3±14.2)s、(466.5±19.1)s。与明胶海绵组比较,海藻酸盐敷料的出血量降低了20.00%,止血时间分别为缩短了31.90%;与纱布比较,海藻酸盐敷料的出血量降低了38.46%,出血时间缩短了51.49%。海藻酸盐敷料的溶血率低于5%。细胞毒性实验中各浓度的海藻酸盐敷料浸提液为0级或1级,提示其对细胞无明显毒性。结论海藻酸盐敷料具有良好的止血效果,溶血率符合国标要求,且对皮肤成纤维细胞无细胞毒性。
Objective To study the hemostatic properties of alginate dressing and to investigate its biocompatibility. Methods The coagulation index test was used to determine the in vitro coagulation performance. Hemostatic properties were measured using a New Zealand rabbit ear and a traumatic hemostasis test. Hemolytic and cytotoxicity tests were performed to assess the safety profile. Results The BCI of alginate dressing and gelatin sponge were 33.1 ± 4.9 and 722.0 ± 3.3 respectively. The alginate dressing had better coagulation effect than gelatin sponge. In the traumatic hemorrhage model, the average bleeding time of alginate dressing, gelatin sponge and gauze was (55.3 ± 5.1) s, (80.2 ± 7.4) s and (101 ± 14.7) s respectively, and the absorbance values of Hb were 1.5 ± 0.7 ± 2.5 ± 0.5, 3.8 ± 0.7. Compared with gelatin sponge, the average bleeding time of alginate dressing was shortened by 31.05% and Hb photometric absorption value was reduced by 40.00%. Compared with gauze, the average bleeding time of alginate dressing was shortened by 45.25%, Hb photometric absorption value was reduced 60.53%. Bleeding amount of alginate dressing, gelatin sponge and gauze were (2.4 ± 0.2) g, (3.0 ± 0.2) g and (3.9 ± 0.2) g, respectively, and bleeding time was (226.3 ± 6.5) s, (332.3 ± 14.2) s, (466.5 ± 19.1) s. Compared with the gelatin sponge group, the alginate dressing reduced the amount of bleeding by 20.00% and the bleeding time by 31.90% respectively. Compared with the gauze, the alginate dressing reduced the bleeding by 38.46% and the bleeding time by 51.49%. Alginate dressing hemolysis rate of less than 5%. Cytotoxicity experiments alginate dressing extract of the concentration of 0 or 1, suggesting that no obvious toxicity on the cells. Conclusion Alginate dressing has a good hemostatic effect, hemolysis rate meets the national standard requirements, and has no cytotoxicity on skin fibroblasts.