乳酸化壳聚糖/透明质酸复合海绵的生物安全性评价  

Biosafety evaluation of chitosan lactate/hyaluronate sponge

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作  者:蔡玉辉[1] 胡克甦 张逸[1] Cai Yuhui;Hu Kesu;Zhang Yi(Department of Burn and Plastic Surgery,Affiliated Hospital of Nantong University,Nantong 226001,Jiangsu Province,China)

机构地区:[1]南通大学附属医院烧伤整形外科,江苏省南通市226001

出  处:《中国组织工程研究》2019年第10期1558-1563,共6页Journal of Clinical Rehabilitative Tissue Engineering Research

基  金:江苏省卫生计生委科研项目(H201625),项目负责人:张逸;南通市关键技术研究计划(MS22016042),项目负责人:蔡玉辉.

摘  要:背景:功能性敷料在临床上使用广泛,但至今没有一款在透气性、生物相容性、舒适性、降解性等方面都能很好满足临床需求的敷料。目的:系统分析改性后的水溶性乳酸化壳聚糖/透明质酸复合海绵的生物安全性能。方法:SPF级6-8周龄雄性BALB/C小鼠10只;SPF级7周龄SD大鼠20只;雌雄各半;8周龄雄性新西兰白兔3只;实验动物均由东莞松山湖明珠实验动物科技有限公司提供。制备乳酸化壳聚糖/透明质酸复合海绵并进行细胞毒性实验,以空白组为对照。采用GB/T16886的生物学评价体系,从生物安全性的角度,对兔进行复合海绵刺激与致敏、皮内反应实验,分为非极性浸提液组、极性浸提液组和阴性对照组,72 h内观察接种部位的反应;对小鼠进行急性毒性实验,分实验组(浸提液)和对照组(纯生理盐水),观察72 h表现;对大鼠进行亚慢性毒性等实验,分实验组(背部皮下植入复合海绵)和对照组(背部皮切开再缝合),观察大鼠体质量变化,13周后静脉取血,做血常规分析,次日麻醉后处死,取心脏、肝脏、脾脏、肾、脑、胰脏、胸腺、胃、膀胱等器官进行大体观察。结果与结论:①改性的复合海绵化学结构符合预期。复合海绵的细胞毒性为1级,与阴性对照组无显著性差异;②皮肤刺激试验表明新西兰白兔皮肤在受到复合海绵刺激后无红斑、无水肿,刺激反应类型为极轻微。几乎不会导致明显的致敏反应;③皮内反应显示新西兰白兔无水肿和红斑,复合海绵的皮内反应刺激非常弱;④急性毒性试验表明注射后小鼠没有明显毒性症状,未出现运动功能减退、呼吸困难、或腹部刺激,72 h观察没有急性全身毒性;⑤在亚慢性毒性试验中,实验组大鼠的体质量与空白对照组动物没有明显差异,血液学结果未观察到明显的毒性特征,实验组与空白对照组动物各脏器系数均无明显差异,没有显示出任何毒性特BACKGROUND:Functional dressings have been widely used in clinical practice,but so far none of existing dressings can meet the clinical needs in terms of gas permeability,biocompatibility,comfort,and degradability.OBJECTIVE:To systemically evaluate the biosafety properties of water-soluble chitosan lactate/hyaluronan sponge after modification.METHODS:In the study,there were 10 male BALB/C mice of SPF grade(6-8 weeks old),20 Sprague-Dawley rats of SPF grade(7 weeks old,both genders),and 3 male New Zealand white rabbits(8 weeks old),all provided by Dongguan Songshanhu Pearl Animal Technology Co.,Ltd.The chitosan lactate/hyaluronan sponge was prepared for cytotoxicity test.A blank control group was set.According to the GB/T16886 biological evaluation system,the rabbits were subjected to composite sponge stimulation and sensitization and intradermal reaction tests from the perspective of biosafety,and then divided into non-polar extract group,polar extract group and negative control group.The inoculation site was observed within 72 hours.The mice were subjected to acute toxicity test,and divided into experimental group(extraction solution)and control group(pure saline),and their manifestations were observed for 72 hours.The rats were subjected to subchronic toxicity test,and then divided into experimental group(subcutaneous implantation of composite sponge)and control group(making a skin incision on the back followed by suturing).The changes in body weight of the rats were observed,blood samples from the rats were taken intravenously for blood routine analysis at 13 weeks after testing,and the rats were anesthetized and executed in the next day for gross observations of the heart,liver,spleen,kidney,brain,pancreas,thymus,stomach,and bladder.RESULTS AND CONCLUSION:(1)The chemical structure of the modified composite sponge formed as expected.The cytotoxicity of the composite sponge was grade 1,which was not significantly different from the negative control group.(2)The skin irritation test showed no skin erythema and ed

关 键 词:乳酸化壳聚糖 复合海绵 透明质酸 壳聚糖 水溶性乳酸化壳聚糖 乳酸 生物相容性 组织工程 

分 类 号:R496[医药卫生—康复医学;医药卫生—临床医学]

 

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