羧化壳聚糖止血及其生物安全性评价  

Hemostatic effect of carboxymethyl chitosan and its biosecurity properties

作　　者：刘霞[1] 赵桂芝[1] 王昱霁 蔡婷婷[1] 朱婉萍[1] 

机构地区：[1]浙江省中医药研究院,浙江省杭州市310007

出　　处：《中国组织工程研究》2017年第22期3561-3566,共6页Chinese Journal of Tissue Engineering Research

基　　金：浙江省科技厅项目(2015F50067)~~

摘　　要：背景:羧化壳聚糖是一类具有优良应用性能的壳聚糖衍生物,良好的生物性能使其在止血材料中具有安全有效的优势。目的:探讨羧化壳聚糖的止血效果及其生物安全性。方法:(1)实验组分别在SD大鼠尾静脉出血创面及肝脏出血创面覆盖羧化壳聚糖粉末,记录止血时间,以创面自然止血时间为对照;(2)实验组分别在ICR小鼠断尾创面、股动脉出血创面及肝脏出血创面覆盖羧化壳聚糖粉末,记录止血时间,以创面自然止血时间为对照;(3)将羧化壳聚糖糊状物、十二烷基硫酸钠溶液及蒸馏水分别直接敷于白化兔皮肤上,进行皮肤刺激实验;(4)在豚鼠皮内注射羧化壳聚糖溶液,进行迟发型超敏反应实验;(5)在白化兔皮下分别注射羧化壳聚糖生理盐水溶液、生理盐水,进行皮内刺激实验;在白化兔皮下分别注射羧化壳聚糖浸提于食用橄榄油的上清液及食用橄榄油,进行皮内刺激实验。结果与结论:(1)与对照组比较,实验组SD大鼠尾静脉、肝脏出血创面止血时间明显缩短(P<0.01);(2)与对照组比较,实验组ICR小鼠断尾创面、股动脉出血创面及肝脏出血创面止血时间明显缩短(P<0.05或P<0.01);(3)羧化壳聚糖对白化兔皮肤无刺激性,具有极轻微的白化兔皮内刺激反应;羧化壳聚糖对豚鼠皮肤无致敏反应;(4)结果表明,羧化壳聚糖对SD大鼠、ICR小鼠创面具有较好的止血作用,对白化兔及豚鼠无明显皮肤刺激、致敏反应及皮内刺激反应,是一种较安全的止血材料。BACKGROUND： Carboxymethyl chitosan （CMCS）, a chitin derivative, has a good application performance that makes it become a safe and effective hemostatic material. OBJECTIVE： To determine the hemostatic effect of CMCS and its biosecurity properties. METHODS： （1） CMCS powder was scattered on the caudal vein and liver wounds of Sprague-Dawley rats, and the hemostatic time was recorded as experimental group, while the time for natural haemostasis of the wound was recorded as control group. （2） CMCS powder was scattered on the tail, femoral artery and liver wounds of ICR mice, and the hemostatic time was recorded as experimental group, while the time for natural haemostasis of the wound was recorded as control group. （3） CMCS, Sodium dodecyl sulfate solution and distilled water were respectively applied on the skin of albino rabbits in a skin irritation test. （4） A delayed-type hypersensitivity test of CMCS was carried out by intradermal injection of CMCS in guinea pigs. （5） An intradermal irritation test was carried out by subcutaneous injection of normal saline containing CMCS and normal saline, respectively. Another intradermal irritation test was carried out by subcutaneous injection of the supernatant of CMCS olive oil extract and olive oil, respectively. RESULTS AND CONCLUSION： （1） Compared with the control group, the hemostatic time for caudal vein and liver wounds were significantly shortened in the Sprague-Dawley rats in the experimental group （P 〈 0.01）. （2） Compared with the control group, the time of hemostasis on the tail, femoral artery and liver wounds was significantly shortened in the ICR mice in the experimental group （P 〈 0.05 or P 〈 0.01）. （3） The CMCS had no irritation to the skin of albino rabbits and no allergic reaction to the skin of guinea pigs. To conclude, the CMCS has good hemostatic effect on the wound in Sprague-Dawley rats and ICR mice, and has no skin irritation, allergic reactions and intradermal irritation reactions in alb

关 键 词：生物材料 材料相容性 羧化壳聚糖 止血 皮肤刺激 皮肤过敏 皮内刺激 安全性评价 

分 类 号：R318[医药卫生—生物医学工程]