α-氰基丙烯酸辛酯医用胶的改性和生物学评价
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摘要
目的:α-氰基丙烯酸辛酯医用胶(简称OCA医用胶)是一种软组织化学粘合剂,与其它软组织胶粘剂相比,具有单组分、无溶剂、可室温快速固化、化学性能稳定、生物相容性好等优点,在临床上得到了广泛的应用,主要有替代手术缝线、粘接固定、快速止血和栓塞堵漏等作用。外科医生希望有一种理想的医用胶出现。但是目前的OCA医用胶与理想医用胶尚有一定差距,如粘接强度不够高、凝固后柔软性差、生物学性能不够理想等缺点。针对以上缺点,我们对OCA医用胶进行了改性,主要是为了提高OCA医用胶的粘接强度、增强柔顺性和生物相容性能等。
方法:本课题选用三种改性材料——邻苯二甲酸酯,聚己内酯和聚甲基丙烯酸辛酯,两种改性方法——常温溶解和高温精馏,对OCA医用胶进行改性研究,并对改性前后的胶体进行粘接性能的测试,然后选出有代表性的改性组进行生物学评价试验。其中,粘接性能的测试包括拉伸剪切力测试、粘接力测试和固化时间与涂胶厚度关系的研究,生物学评价试验严格按照GB/T 16886的要求,进行细胞毒性试验,溶血试验,遗传毒性试验,刺激试验,致敏试验,全身毒性,植入试验和慢性毒性试验等十项评价试验,对改性前后的医用胶进行生物学性能的初步评价分析。
结果:三种改性材料的不同改性方法中,常温下溶解聚己内酯改性组的粘接强度有所下降,其余各组的粘接强度都有不同程度的提高。其中,聚己内酯高温精馏组的粘接强度的与改性前相比,有统计学差异。生物学评价试验结果显示,OCA医用胶的细胞毒性、溶血和染色体畸变的结果都符合医疗器械标准的要求,用聚己内酯改性的医用胶的细胞毒性下降,聚甲基丙烯酸辛酯改性的医用胶的溶血率降低。
结论:选用的改性材料和方法对OCA医用胶进行改性后,粘结强度和生物相容性都有不同程度的提高,说明改性是有意义的。为了保证改性后材料的安全性,今后还将继续进行刺激试验,致敏试验,全身毒性,植入试验和慢性毒性试验等几项生物学评价试验。
Objective:Octyl-α-Cyanoacrylate adhesive(OCA) is a kind of chemical adhesive used for soft tissue.Compared to other tissue adhesives,it is monomer and has attributes of rapid solidification,steady chemical character and good biocompatibility. In clinical application,it has already been used for the alternative of suture,fixation, hemostasia,blocking the leak and so on.The surgeons hope there is a kind of ideal medical adhesive,but the OCA adhesive in market now still can not satisfy the requirements.For example,the strength is not high enough,the facility after solidification is not very good,and neither the biocompatibility.Reformations for the OCA adhesive is studied in this dissertation,with the purpose of improving the adhesive strength,facility after solidification and biocompatibility.
Methods:Three chemicals and two methods are chosen to reform the OCA adhesive,and agglutinate tests of the OCA before and after reformation have been carried.Then,certain groups were chosen as the evaluation of biocompatibility test group.The agglutinate tests include stretch shearing force test and adhesive strength test,and the biomedical evaluation includes tests for invitro cytotoxicity,hemolysis test,genetic-toxicity test,tests for irritation and delayed-type hypersensitivity,tests for systemic toxicity,embedded experiment and so on based on the GB/T 16886.
Results:The PCL group in normal temperature is descended while the other groups are enhanced.And the intention of the rectified group is improved and has statistical difference compared to the OCA reformed before.The result of the biological evaluation indicates that,the vitro cytotoxicity,hemolysis,and the genetic-toxicity results of the OCA adhesive are up to grade.And the PCL group has low invitro cytotoxicity,while the POMA group has better hemolysis results.
Conclusions:After the reformation,the adhesive strength and biocompatibility are promoted,which indicates that the reformation is effective.In order to guarantee the security of the OCA adhesive,the other biocompatibility tests are still needed.
方法:本课题选用三种改性材料——邻苯二甲酸酯,聚己内酯和聚甲基丙烯酸辛酯,两种改性方法——常温溶解和高温精馏,对OCA医用胶进行改性研究,并对改性前后的胶体进行粘接性能的测试,然后选出有代表性的改性组进行生物学评价试验。其中,粘接性能的测试包括拉伸剪切力测试、粘接力测试和固化时间与涂胶厚度关系的研究,生物学评价试验严格按照GB/T 16886的要求,进行细胞毒性试验,溶血试验,遗传毒性试验,刺激试验,致敏试验,全身毒性,植入试验和慢性毒性试验等十项评价试验,对改性前后的医用胶进行生物学性能的初步评价分析。
结果:三种改性材料的不同改性方法中,常温下溶解聚己内酯改性组的粘接强度有所下降,其余各组的粘接强度都有不同程度的提高。其中,聚己内酯高温精馏组的粘接强度的与改性前相比,有统计学差异。生物学评价试验结果显示,OCA医用胶的细胞毒性、溶血和染色体畸变的结果都符合医疗器械标准的要求,用聚己内酯改性的医用胶的细胞毒性下降,聚甲基丙烯酸辛酯改性的医用胶的溶血率降低。
结论:选用的改性材料和方法对OCA医用胶进行改性后,粘结强度和生物相容性都有不同程度的提高,说明改性是有意义的。为了保证改性后材料的安全性,今后还将继续进行刺激试验,致敏试验,全身毒性,植入试验和慢性毒性试验等几项生物学评价试验。
Objective:Octyl-α-Cyanoacrylate adhesive(OCA) is a kind of chemical adhesive used for soft tissue.Compared to other tissue adhesives,it is monomer and has attributes of rapid solidification,steady chemical character and good biocompatibility. In clinical application,it has already been used for the alternative of suture,fixation, hemostasia,blocking the leak and so on.The surgeons hope there is a kind of ideal medical adhesive,but the OCA adhesive in market now still can not satisfy the requirements.For example,the strength is not high enough,the facility after solidification is not very good,and neither the biocompatibility.Reformations for the OCA adhesive is studied in this dissertation,with the purpose of improving the adhesive strength,facility after solidification and biocompatibility.
Methods:Three chemicals and two methods are chosen to reform the OCA adhesive,and agglutinate tests of the OCA before and after reformation have been carried.Then,certain groups were chosen as the evaluation of biocompatibility test group.The agglutinate tests include stretch shearing force test and adhesive strength test,and the biomedical evaluation includes tests for invitro cytotoxicity,hemolysis test,genetic-toxicity test,tests for irritation and delayed-type hypersensitivity,tests for systemic toxicity,embedded experiment and so on based on the GB/T 16886.
Results:The PCL group in normal temperature is descended while the other groups are enhanced.And the intention of the rectified group is improved and has statistical difference compared to the OCA reformed before.The result of the biological evaluation indicates that,the vitro cytotoxicity,hemolysis,and the genetic-toxicity results of the OCA adhesive are up to grade.And the PCL group has low invitro cytotoxicity,while the POMA group has better hemolysis results.
Conclusions:After the reformation,the adhesive strength and biocompatibility are promoted,which indicates that the reformation is effective.In order to guarantee the security of the OCA adhesive,the other biocompatibility tests are still needed.
引文
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[1]夏毅然,徐永祥,刘文冰,等.医用粘合剂的研究及应用进展[J].化工新型材料,2003,31(4):9-12.
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[4]陈子达,李玲,邹翰.医用胶粘剂的研究进展[J].化学与粘合,2001(1):21-22,28.
[5]刘芝兰,张健民,陈立贵.医用粘合剂的研究及临床应用进展[J].粘接,2002,23(1):28-31.
[6]曾国蓉,冯地旺,邓德贤,等.新型医用粘合剂:α-氰基丙烯酸 1,2 异丙叉甘油酯的合成[J].中国胶粘剂,1993,2(1):20.
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[8]王养忠,朱豫,周丽君,等.EC 耳脑胶在眶壁修复术中应用[J].中国实用眼科杂志, 2004,22(5):400.
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[12]Nitsch A.Cellular,histomorphologic,and clinical charac-teristics of a new octyl-2-cyanoacrylate skin adhesive[J].Aesthetic Plastic Surgery,2005,29:53-58.
[13]熊林,王建营,延玺,等.丙烯酸酯胶粘剂研究进展[J].中国胶粘剂,2002,11(3):47-52.
[14]徐梅,赵敏,李鸿.α-氰基丙烯酸正辛酯在小梁切除术中应用的初步报告[J].眼外伤职业眼病杂志,2007,29(8):581-583.
[15]吕波,屠重琪,裴福兴,等.α-氰基丙烯酸正辛酯黏接兔桡骨横断骨折的效果[J].中国临床康复,2006,10(17):51-53.
[16]秦应祥,赵敏.组织粘合剂在眼科中的应用[J].国际眼科杂志,2004,4(4):690-694
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[18]思永玉,王泉云,徐志勇,等.α-氰基丙烯酸酯医用胶和医用生物蛋白胶对大鼠神经功能的影响[J].四川医学,lectomy[J].British Journal of Ophthalmology,1991,75(4):217-218.
[21]张茂合.清创粘合术在皮肤裂伤患者中的应用[J].中华急诊医学杂志,2007,16(1):83-86.
[22]汤学付,董诺,汪振芳.组织粘合剂粘合羊膜手术在眼烧伤中的应用[J].眼科学报,2005,21(2):74-78.
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