新型免縫線硅膠角膜環(huán)的理化特性及其生物相容性研究
發(fā)布時(shí)間：2018-11-06 07:55
【摘要】：目的玻璃體切除術(shù)中,角膜接觸鏡已得到廣泛使用,配合接觸鏡使用的角膜接觸鏡固定環(huán)的改進(jìn)也倍受關(guān)注。本研究研制了一種新型免縫線的角膜接觸鏡固定環(huán),本文為該免縫線硅膠角膜環(huán)的理化性能特征和生物相容性的研究,為其在臨床應(yīng)用提供必要的實(shí)驗(yàn)數(shù)據(jù)。 方法1.免縫線硅膠角膜環(huán)試片的制備。2.使用LX2A型邵氏橡膠硬度計(jì)對(duì)新型免縫線硅膠角膜環(huán)進(jìn)行邵氏硬度測(cè)試,取不同位置測(cè)量5次,記錄數(shù)據(jù)并計(jì)算算術(shù)平均數(shù)。3.使用AIPU ALJ-02型雙數(shù)顯拉力試驗(yàn)機(jī)對(duì)其進(jìn)行拉伸應(yīng)力應(yīng)變測(cè)試、撕裂強(qiáng)度測(cè)試。4.使用透光率/霧度測(cè)定儀對(duì)其透光率和霧度進(jìn)行測(cè)試。5.收集人角膜上皮細(xì)胞,對(duì)該角膜環(huán)進(jìn)行細(xì)胞毒分析以評(píng)價(jià)新型免縫線硅膠角膜環(huán)的細(xì)胞性。6.選用6只成年健康成年大耳白兔,麻醉后,右眼表面麻醉,在其右眼結(jié)膜囊內(nèi)放置硅膠環(huán)產(chǎn)品4h,然后分別于6h、24h、48h、72h后,予所有白兔右眼行角膜熒光素染色,裂隙燈下觀察角膜染色情況,并記錄白兔角膜熒光素著色面積以對(duì)硅膠環(huán)產(chǎn)品的刺激反應(yīng)進(jìn)行評(píng)價(jià)。7.另選6只成年SD大鼠,于每只大鼠麻醉后腹部備皮,予備皮處皮膚表面放置硅膠環(huán)試片4h,并于取出試片后6h、24h、48h、72h測(cè)量SD大鼠局部皮膚紅腫的面積并記錄,以評(píng)價(jià)其過(guò)敏反應(yīng)。 結(jié)果新型免縫線硅膠角膜環(huán)的邵氏硬度為63.4度,拉伸強(qiáng)度大于5.86 MPa,伸長(zhǎng)率大于100%,撕裂強(qiáng)度為34 kN/m。新型免縫線硅膠角膜環(huán)3爪的透光率均大于93%,而霧度均小于0.1%。免縫線硅膠角膜環(huán)對(duì)角膜細(xì)胞的細(xì)胞毒性測(cè)試值為3.11×10-6%。結(jié)膜囊內(nèi)放置免縫線硅膠角膜環(huán)6h、24h、48h、72h,所有的兔眼均未見(jiàn)角膜熒光素著色,P0.05。實(shí)驗(yàn)前及免縫線硅膠角膜環(huán)置于SD大鼠皮膚表面后6h、24h、48h和72 h,所有的SD大鼠皮膚均未見(jiàn)紅腫,P0.05。 結(jié)論采用的硅橡膠理化特性能滿足角膜環(huán)的制作要求,生物學(xué)評(píng)價(jià)符合ISO10993-1評(píng)估醫(yī)療器材生物相容性的國(guó)際標(biāo)準(zhǔn)和生物體的要求,是制備角膜環(huán)較為理想的材料。
[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.
【學(xué)位授予單位】：天津醫(yī)科大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2011
【分類號(hào)】：R779.6
本文編號(hào)：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.
【學(xué)位授予單位】：天津醫(yī)科大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2011
【分類號(hào)】：R779.6
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