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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。
Objective To understand the toxicity and biocompatibility of a chitosan antibacterial film-forming agent. Methods The biological safety of this preparation was evaluated by animal experiments and cytotoxicity test methods. Results The chitosan preparation was an antibacterial spray film preparation, and its active ingredient was chitosan containing 1% mass fraction. The antibacterial spray film had no significant effect on the morphology of L-929 cells cultured in vitro, and had no obvious inhibitory effect on the cell growth and proliferation. The cytotoxicity was 0 grade. In the New Zealand rabbits vaginal use of the antibacterial spray mucosal mucosa was found slightly hyperemia, histopathology observed a strong degree of vascular congestion, stimulation index of 1.44, is a very light irritant. The antibacterial spray film has no erythema and edema reaction on the intact skin of guinea pigs, which is not sensitizing grade. Conclusion The antibacterial spray membrane has no cytotoxic effect in vitro and has no sensitization to the intact skin of experimental animals, but it has extremely mild irritation to animal vaginal mucosa and has good biosafety.