一种壳聚糖抗菌喷膜剂的生物安全性评价

目的了解一种壳聚糖抗菌喷膜剂的毒性及生物相容性。方法通过动物实验和细胞毒性试验方法,对该制剂的生物安全性进行了评价。结果该壳聚糖制剂为一种抗菌喷膜制剂,其有效成分为含质量分数1%壳聚糖。该抗菌喷膜对体外培养的L-929细胞形态无明显影响,对细胞生长和增殖无明显抑制作用,细胞毒性均为0级。在新西兰家兔的阴道使用该抗菌喷膜黏膜后发现黏膜有轻微充血,组织病理学观察到血管充血程度较强,刺激指数为1.44,属极轻刺激性。该抗菌喷膜对豚鼠完整皮肤无致红斑和水肿反应,属不致敏级。结论该抗菌喷膜无体外细胞毒作用,对试验动物完整皮肤无致敏性,但对动物阴道黏膜有极轻度刺激性,具有较好的生物安全性。

BIOLOGICAL SAFETY EVALUATION OF CHITOSAN ANTIBACTERIAL SPRAY

Objective To understand the toxicity and biocompatibility of chitosan antibacterial spray in order to assess its safety.Methods Animal test and cytotoxicity test in vitro were performed to evaluate the biological safety of this biological disinfectant.Results Chitosan antibacterial spray containing 1% chitosan had no significant effect on the L-929 cell morphology and had no significant inhibition on cell growth and proliferation;The cytotoxicity gradation was 0 degree in various concentration of leaching liquors of test materials.Mild irritation was found in vaginal mucosa of rabbit,vas congestion was found in pathological test and irritation index was 1.44 which belonged to mild irritation grade.No skin erythema and edema was found in albinism animal test,which belonged to no-hypersensitivity.Conclusion This chitosan antibacterial spray used for mucosa has mild stimulation,good biocompatibility and biological safety.