PU材料宫内装置生物相容性及物理机械性能的研究

发布时间：2018-01-17 14:00

本文关键词：PU材料宫内装置生物相容性及物理机械性能的研究　出处：《中南大学》2014年博士论文　论文类型：学位论文

【摘要】：目的： 1.通过动物体内植埋实验及体外细胞毒性试验评估聚氨酯(PU)材料宫内装置(自主专利产品)的生物相容性。 2.通过测量PU材料宫内装置的各项物理机械性能,评估其是否满足宫内装置的设计要求。方法： 1.根据GB/T1688.和IS010993.规定,对PU材料宫内装置进行动物体内植埋及体外细胞毒性试验。动物体内植埋实验：①实验材料：医用PU材料宫内装置、T型环聚乙烯(PE)支架；②实验分组：按体重将18只健康的SD雌性大鼠依次编号,随机分为3组,分别将实验材料模块植入SD大鼠的双侧后腿部,实验组为植入PU材料组,对照组为植入PE材料组,而空白组仅对大鼠左侧前腿做切开缝合处理。分别于术后的第7、30、90天取出植入材料的模块周围组织,观察后制成HE切片。光镜下观察切片,评估组织的炎性反应程度,判断两种材料的差异性。体外细胞毒性实验：①实验细胞：小鼠成纤维细胞；②实验分组：空白组、PE浸提液组、不同浓度(100%、50%、25%)的PU材料浸提液组。于培养后的第 1、3、7天通过CCK-8法染色,孵育约3小时,在酶标450nm波长处测定吸光值,计算相对增殖率,显微镜下观察各组细胞形态,评估其细胞毒性。 2.物理机械性能测定：测试PU材料、PE材料及医用硅橡胶的各项物理机械性能,包括硬度、扯断伸长率、拉伸强度、100%定伸强度等方面和耐疲劳实验。结果： 1.动物体内植埋实验：所有大鼠安全耐受麻醉及手术,伤口愈合良好。术后7天、30天、90天,PU组与PE组对组织的炎性反应程度均无明显差异(P0.05)。 2.体外细胞毒性试验：CCK-8法测定细胞OD值,随培养时间的延长,不同浓度的PU材料浸提液对细胞增殖有促进作用(P0.05),细胞增殖与浸提液的浓度无明显相关(P0.05),实验组、对照组及空白组间无明显差异,该材料的细胞毒性为0-1级。3.物理机械性能：根据第三方检测报告数据表明,PU材料的各项物理机械性能均优于PE材料及医用硅橡胶。结论：PU材料宫内装置具有良好的生物相容性,其物理性能符合该专利产品的设计要求。
[Abstract]:Objective: 1. The biocompatibility of intrauterine devices (proprietary products) of polyurethane (pu) was evaluated by in vivo and in vitro cytotoxicity tests. 2. The physical and mechanical properties of pu intrauterine device are measured to evaluate whether it meets the design requirements of the intrauterine device. Methods: 1.According to the regulations of GB / T 1688. and IS010993., in vivo and in vitro cytotoxicity tests were carried out on the intrauterine device of pu. Animal implantation experiment: 1 Experimental material: medical pu material Intrauterine device T-type cyclic Polyethylene (PEE) scaffold; 2Experimental group: 18 healthy female SD rats were randomly divided into 3 groups according to their body weight. The experimental material modules were implanted into the posterior legs of SD rats respectively, and the experimental group was implanted with pu. The control group was implanted with PE, while the blank group only performed incision and suture on the left foreleg of the rats. The tissue around the module of the implanted material was taken out on the 7th day and 30th day 90 days after operation. After observation, HE sections were made. The sections were observed under light microscope to assess the degree of inflammatory reaction and to judge the difference between the two materials. In vitro cytotoxicity test: mouse fibroblasts; 2 Experimental group: blank group, PE extraction solution group, different concentration of Pu material extraction solution group. The cells were stained with CCK-8 for 7 days and incubated for 3 hours. The absorptivity was measured at 450 nm wavelength, the relative proliferation rate was calculated, and the morphology of each group was observed under microscope. Evaluate its cytotoxicity. 2. Determination of physical and mechanical properties: test the physical and mechanical properties of pu / PE and medical silicone rubber, including hardness, elongation at break and tensile strength. 100% tensile strength and fatigue test. Results: 1. In vivo implantation experiment: all the rats safely tolerated anesthesia and operation, the wound healed well, 7 days after operation 30 days and 90 days after operation. There was no significant difference in the degree of inflammatory reaction between pu group and PE group. 2. In vitro cytotoxicity test, the OD value of the cells was determined by the cell cytotoxicity test: with the extension of culture time, the extractions of pu with different concentrations could promote cell proliferation (P0.05). There was no significant correlation between cell proliferation and the concentration of extractant, but there was no significant difference between experimental group, control group and blank group. The cytotoxicity of the material is 0-1 grade .3.Physico-mechanical properties: according to the data of the third party testing report, the physical and mechanical properties of the pu material are superior to those of PE material and medical silicone rubber. Conclusion the device has good biocompatibility and its physical properties meet the design requirements of the patent product.
【学位授予单位】：中南大学
【学位级别】：博士
【学位授予年份】：2014
【分类号】：R318.08;R169.43

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