新型免缝线硅胶角膜环的理化特性及其生物相容性研究
发布时间：2018-11-06 07:55
【摘要】：目的玻璃体切除术中,角膜接触镜已得到广泛使用,配合接触镜使用的角膜接触镜固定环的改进也倍受关注。本研究研制了一种新型免缝线的角膜接触镜固定环,本文为该免缝线硅胶角膜环的理化性能特征和生物相容性的研究,为其在临床应用提供必要的实验数据。 方法1.免缝线硅胶角膜环试片的制备。2.使用LX2A型邵氏橡胶硬度计对新型免缝线硅胶角膜环进行邵氏硬度测试,取不同位置测量5次,记录数据并计算算术平均数。3.使用AIPU ALJ-02型双数显拉力试验机对其进行拉伸应力应变测试、撕裂强度测试。4.使用透光率/雾度测定仪对其透光率和雾度进行测试。5.收集人角膜上皮细胞,对该角膜环进行细胞毒分析以评价新型免缝线硅胶角膜环的细胞性。6.选用6只成年健康成年大耳白兔,麻醉后,右眼表面麻醉,在其右眼结膜囊内放置硅胶环产品4h,然后分别于6h、24h、48h、72h后,予所有白兔右眼行角膜荧光素染色,裂隙灯下观察角膜染色情况,并记录白兔角膜荧光素着色面积以对硅胶环产品的刺激反应进行评价。7.另选6只成年SD大鼠,于每只大鼠麻醉后腹部备皮,予备皮处皮肤表面放置硅胶环试片4h,并于取出试片后6h、24h、48h、72h测量SD大鼠局部皮肤红肿的面积并记录,以评价其过敏反应。 结果新型免缝线硅胶角膜环的邵氏硬度为63.4度,拉伸强度大于5.86 MPa,伸长率大于100%,撕裂强度为34 kN/m。新型免缝线硅胶角膜环3爪的透光率均大于93%,而雾度均小于0.1%。免缝线硅胶角膜环对角膜细胞的细胞毒性测试值为3.11×10-6%。结膜囊内放置免缝线硅胶角膜环6h、24h、48h、72h,所有的兔眼均未见角膜荧光素着色,P0.05。实验前及免缝线硅胶角膜环置于SD大鼠皮肤表面后6h、24h、48h和72 h,所有的SD大鼠皮肤均未见红肿,P0.05。 结论采用的硅橡胶理化特性能满足角膜环的制作要求,生物学评价符合ISO10993-1评估医疗器材生物相容性的国际标准和生物体的要求,是制备角膜环较为理想的材料。
[Abstract]:Objective Corneal contact lens has been widely used in vitrectomy, and the improvement of contact lens fixation ring combined with contact lens has attracted much attention. In this study, a new suture free contact lens fixation ring was developed. This study provided necessary experimental data for the study of the physical and chemical properties and biocompatibility of the suture free silicone corneal ring. Method 1. Preparation of suture free silicone corneal ring test. 2. Shao's hardness of the new seam-free silicone corneal ring was tested with LX2A type Shao's rubber hardness meter. Five times were measured in different positions. The data were recorded and the arithmetic average was calculated. The tensile stress and strain and tear strength of AIPU ALJ-02 double digital display tensile force tester were tested. 4. 4. The transmittance and foggy were measured by using the transmittance / fogging tester. 5. 5. Human corneal epithelial cells were collected and cytotoxic analysis was carried out to evaluate the cytotoxicity of the new seam-free silicone corneal ring. Six adult healthy adult white rabbits were selected. After anaesthesia, the right eye was anesthetized. The silicone ring was placed in the conjunctiva sac of the right eye for 4 hours, and then the cornea fluorescein staining was performed on the right eye of all the rabbits at 6h, 24h, 48h, 48h and 72h, respectively. The corneal staining was observed under slit lamp and the area of fluorescein staining in rabbit cornea was recorded to evaluate the stimulating reaction of silica gel ring. In addition, 6 adult SD rats were selected. After anesthesia, the skin was placed on the skin surface of each rat for 4 hours. The area of local skin redness in SD rats was measured and recorded at 6h, 24h, 48h and 72h, respectively. To evaluate its allergic reaction. Results the Shore hardness, tensile strength and tear strength of the new suture free silicone corneal ring were 63.4 degrees, 5.86 MPa, and 34 kN/m., respectively. The light transmittance of the new suture free silicone cornea ring 3 claw is higher than 933%, while the fog degree is less than 0.1%. The cytotoxicity of silicone free corneal ring to corneal cells was 3.11 脳 10 ~ (-6). In the conjunctival sac, the suture free silicone corneal ring was placed at 6 h, 24 h and 48 h for 72 h. No fluorescein staining was found in all rabbit eyes (P0.05). Before the experiment and after the suture free silicone corneal ring was placed on the skin surface of SD rats at 6 h, 24 h and 72 h, no red swelling was found in the skin of all SD rats (P0.05). Conclusion the physical and chemical properties of silicone rubber can meet the requirements of making corneal rings. The biological evaluation meets the international standards of ISO10993-1 for evaluating the biocompatibility of medical devices and the requirements of biology. It is an ideal material for preparing corneal rings.
【学位授予单位】：天津医科大学
【学位级别】：硕士
【学位授予年份】：2011
【分类号】：R779.6
本文编号：2313639
[Abstract]:Objective Corneal contact lens has been widely used in vitrectomy, and the improvement of contact lens fixation ring combined with contact lens has attracted much attention. In this study, a new suture free contact lens fixation ring was developed. This study provided necessary experimental data for the study of the physical and chemical properties and biocompatibility of the suture free silicone corneal ring. Method 1. Preparation of suture free silicone corneal ring test. 2. Shao's hardness of the new seam-free silicone corneal ring was tested with LX2A type Shao's rubber hardness meter. Five times were measured in different positions. The data were recorded and the arithmetic average was calculated. The tensile stress and strain and tear strength of AIPU ALJ-02 double digital display tensile force tester were tested. 4. 4. The transmittance and foggy were measured by using the transmittance / fogging tester. 5. 5. Human corneal epithelial cells were collected and cytotoxic analysis was carried out to evaluate the cytotoxicity of the new seam-free silicone corneal ring. Six adult healthy adult white rabbits were selected. After anaesthesia, the right eye was anesthetized. The silicone ring was placed in the conjunctiva sac of the right eye for 4 hours, and then the cornea fluorescein staining was performed on the right eye of all the rabbits at 6h, 24h, 48h, 48h and 72h, respectively. The corneal staining was observed under slit lamp and the area of fluorescein staining in rabbit cornea was recorded to evaluate the stimulating reaction of silica gel ring. In addition, 6 adult SD rats were selected. After anesthesia, the skin was placed on the skin surface of each rat for 4 hours. The area of local skin redness in SD rats was measured and recorded at 6h, 24h, 48h and 72h, respectively. To evaluate its allergic reaction. Results the Shore hardness, tensile strength and tear strength of the new suture free silicone corneal ring were 63.4 degrees, 5.86 MPa, and 34 kN/m., respectively. The light transmittance of the new suture free silicone cornea ring 3 claw is higher than 933%, while the fog degree is less than 0.1%. The cytotoxicity of silicone free corneal ring to corneal cells was 3.11 脳 10 ~ (-6). In the conjunctival sac, the suture free silicone corneal ring was placed at 6 h, 24 h and 48 h for 72 h. No fluorescein staining was found in all rabbit eyes (P0.05). Before the experiment and after the suture free silicone corneal ring was placed on the skin surface of SD rats at 6 h, 24 h and 72 h, no red swelling was found in the skin of all SD rats (P0.05). Conclusion the physical and chemical properties of silicone rubber can meet the requirements of making corneal rings. The biological evaluation meets the international standards of ISO10993-1 for evaluating the biocompatibility of medical devices and the requirements of biology. It is an ideal material for preparing corneal rings.
【学位授予单位】：天津医科大学
【学位级别】：硕士
【学位授予年份】：2011
【分类号】：R779.6
【参考文献】
相关期刊论文 前3条
1 苏花平,李中华;医用高分子材料—硅橡胶[J];化学世界;2005年03期
2 胡夏云;邢怡桥;贺涛;梅海峰;武丽娜;;23G TVS在治疗玻璃体视网膜疾病中的应用[J];眼科新进展;2010年07期
3 张承焱;医用高分子材料的应用研究及发展[J];中国医疗器械信息;2005年05期
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