CN106671504A - 一种外科手术用无纺布复合纱布片 - Google Patents
一种外科手术用无纺布复合纱布片 Download PDFInfo
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- CN106671504A CN106671504A CN201611037790.6A CN201611037790A CN106671504A CN 106671504 A CN106671504 A CN 106671504A CN 201611037790 A CN201611037790 A CN 201611037790A CN 106671504 A CN106671504 A CN 106671504A
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Abstract
一种外科手术用无纺布复合纱布片,包括无纺布片、纱布片、其特征在于:所述无纺布片与纱布片复合,纱布片上复合有竹纤维纱布层和敷料层,所述敷料层由抑菌层、促愈层和止血层复合而成。本发明具有吸水力强、不脱线、不掉毛,能与先进的手术传感器具融合、医疗功能性强等效果,具有极高的社会效益和经济效益。
Description
技术领域
本发明涉及一种医用纱布,尤其是涉及一种外科手术用无纺布复合纱布片。
背景技术
医用纱布是医疗机构外科和外科手术中不可缺少的医疗用品,其主要材料是由脱脂棉构成,医用纱布的一个主要使用方面是对患者的伤口进行包扎。传统的纱布结构十分简单,功能也非常有限,由于伤口或患处的组织或血水沾染纱布,使纱布易繁殖细菌,带有细菌的纱布,容易造成伤口感染,难以愈合,给伤者造成二次伤害。且目前纱布使用有效期的管理、手术后纱布的清点回收等作业都很难规范,因而经常有手术过程中不慎将纱布遗留在患者体内的医疗事故发生。
发明内容
本发明目的是提供一种外科手术用无纺布复合纱布片,以解决传统的纱布结构简单、无抑菌和促愈合的功效、手术中发生不慎将纱布遗留在患者体内导致医疗事故等技术问题。
为解决上述技术问题,本发明采用的技术方案是:一种外科手术用无纺布复合纱布片,包括无纺布片、纱布片、其特征在于:所述无纺布片与纱布片复合,纱布片上复合有竹纤维纱布层和敷料层,所述敷料层由抑菌层、促愈层和止血层复合而成,所述抑菌层包括苯扎氯铵4~5份、皂甙3~6份、甘草4~8份、丁香2~5份、忍冬藤1~4份、羟丙基纤维素5~8份;所述促愈层4包含槲皮素5~7份、角蛋白3~8份、聚六亚甲基胍6~9份、甘油2~8份、溶菌酶1.5~5份、三七3~7份、羟丙基纤维素5~8份、远红外陶瓷粉5~9份;所述止血层5包含咖啡酸3~8份、马鞭草苷2~4份、苄丙酮香豆素2.5~5份、白毛茛碱4~7份、羟丙基纤维素5~8份。
作为优选,所述无纺布片包括纺粘无纺布层,熔喷无纺布层,所述熔喷无纺布层下设有柔性金属丝网层,所述柔性金属丝网层下复合有纺粘无纺布层,纺粘无纺布层下复合有吸水材料层。
作为优选,所述柔性金属丝网层由棉纤维、聚酯纤维、银丝纤维相互交织而成,其中棉纤维为经线,聚酯纤维、银丝纤维合股后构成纬线与经线编织构成柔性金属丝网层。
本发明具有吸水力强、不脱线、不掉毛,能与先进的手术传感器具融合、医疗功能性强等效果。其中多层复合的无纺布结构可以减少传统的纱布片或无纺布片脱线掉毛的现象,而柔性金属丝网层不影响纱布的柔软性,并且可以被金属探测仪探测到,因此不会造成纱布遗失,避免纱布遗失在手术病人体内的现象发生。多层结构可以防止可以减少传统的纱布片或无纺布片脱线掉毛的现象。另外,纱布中的亲肤复合层由抑菌层、促愈层和止血层复合而成,止血层的药物成分可以有效的缩短凝血和出血时间,大大降低了伤者的痛苦,为医务人员进一步治疗提供了时间保障;抑菌层的抑菌药物成分可以对伤口进行杀菌处理,有效的解决了纱布会滋生病菌,造成伤口感染等问题,促愈层的有效药物成分可以使伤口更快的愈合,为伤口的快速愈合提供了保障。
附图说明
图1所示是本发明的结构示意图;
图2是图1所示敷料层的结构示意图;
图3是图1所示无纺布片结构示意图;
图4是图3所示柔性金属网层的结构示意图。
具体实施方式
下面结合附图和具体实施例对本发明进一步说明:
一种外科手术用无纺布复合纱布片,包括无纺布片4、纱布片3、其特征在于:所述无纺布片4与纱布片3复合,纱布片3上复合有竹纤维纱布层2和敷料层1,所述敷料层1由抑菌层11、促愈层12、止血层13复合而成。本发明中,竹纤维纱布层具有良好的透气性、瞬间吸水性、较强的耐磨性和良好的染色性等特性,同时又具有天然抗菌、抑菌、除螨、防臭和抗紫外线功能。
无纺布片4包括纺粘无纺布层43,熔喷无纺布层41,熔喷无纺布层41下设有柔性金属丝网层42,柔性金属丝网层42下复合有纺粘无纺布层43,纺粘无纺布层43下复合有吸水材料层44。
作为优选,所述柔性金属丝网层42由棉纤维、聚酯纤维、银丝纤维相互交织而成,其中棉纤维51为经线,聚酯纤维52、银丝纤维53合股后构成纬线与经线编织构成柔性金属丝网层42。
柔性金属丝网层42是在聚氨酯材料外部电镀金属形成的针织平面层,具有优异的柔性,克服了普通金属丝或金属薄膜在使用过程中容易产生金属疲劳进而发生断裂的缺陷,并且可以给金属探测仪探测到,从而不会造成纱布遗失,避免纱布遗失在手术病人体内的现象发生。
抑菌层11配方是:苯扎氯铵4份、皂甙6份、甘草7份、丁香4份、忍冬藤3份、羟丙基纤维素5份,其中皂甙具有很强的抗菌活性和广谱抗菌作用,它对溶血性金黄色葡萄球菌、溶血性链菌、伤寒杆菌、大肠杆菌、变形杆菌及其常见的致病性皮肤真菌均有较强的抑制性。
促愈层1配方是:槲皮素5份、角蛋白8份、聚六亚甲基胍9份、甘油5份、溶菌酶3.5份、三七4份、羟丙基纤维素5份、远红外陶瓷粉6份,其中槲皮素,为一种能增加成纤维细胞增殖的植物成分,可以提高成纤维细胞的增殖、促进伤口的愈合,保护皮肤和皮下组织。
止血层13配方是:咖啡酸3份、马鞭草苷1份、苄丙酮香豆素4.5份、白毛茛碱5份、羟丙基纤维素5份,其中咖啡酸不仅具有较广泛的抗病毒活性和抑菌作用,而且还具有良好的缩短凝血和出血时间的作用。
制作方法:将各组药物研为细粉,过80目~100目筛,称量混合均匀,密封备用。将各组药物分别与体积浓度60—70%乙醇、微量扩散剂、活性剂混合搅拌,24小时后在纱布上喷涂抑菌层,烘干后喷涂促愈层、烘干后喷涂止血层,最后烘干后得到敷料1。
试验分析:下面通过抑菌试验和动物试验对本发明的效果进行进一步验证分析。
一、抑菌试验:
1、材料与方法
试验材料金黄色葡萄球菌(CMCC(B)26112,北京谱析科技有限公司) ,白色念珠菌(CMCC(F)98001,北京谱析科技有限公司) ; 营养肉汤、营养琼脂培养基、改良马丁培养基和沙氏琼脂由北京谱析科技有限公司提供;敷料分别为本发明生产的a、b二批医用敷料样品。
2、方法
1)温度、摇床转速对微生物的影响:将新鲜的金黄色葡萄球菌培养物、白色念珠菌培养物稀释适宜的倍数后,接种到20 mL 磷酸盐缓冲液( 0. 03 mol·L - 1 ) 中,调整菌液浓度约为5 × 104 cfu·mL - 1,分别放在转速为100,200, 300 r·min - 1,温度为25℃和37 ℃条件下振摇培养,在0 h、1 h 取菌液计数,每组重复3 次,计算振摇前后的菌落数差值( %) 。
2)烧瓶振荡法检测无纺布复合纱布片敷料的抗菌性能:本研究采用优化条件的烧瓶振荡法对2 批医用敷料敷料的抗菌性能( 金黄色葡萄球菌、白色念珠菌) 进行了评价。具体方法: 取无纺布复合纱布片敷料层,剪成1 cm × 1 cm 大小,精确称重( 0. 75 g)后置于无菌锥形瓶中作为样片组,并按上述方法制备不含敷料涂层的同材质织布作为对照样片组,同时制备不加样片组。
将3组分别加入70 mL 磷酸盐缓冲液( 0. 03 mol·L - 1 )和5 mL 金黄色葡萄球菌( 或白色念珠菌) 的菌液,在25 ℃、200 r·min - 1条件下,振摇培养1 h。分别于0h、1 h 取样,计算细菌数量变化。每批产品试验重复3 次,计算平均抑菌率。抗菌率的计算:依据公式X = ( A - B) / × A × 100%,X 为抑菌率,A 为试样品振荡前平均菌落数,B为试样品振荡后平均菌落数。判断标准: 不加样片组振摇前后的菌落数差值要在10%以内,试验样品抑菌率与对照样品抑菌率之差≥26%,可判定该产品有抗菌作用。
3、抑菌环试验:这种方法可以模拟产品在潮湿或有轻度渗出液的伤口上时敷料控制微生物增长的能力。用与烧瓶振荡法中所用相同的2个批号的敷料,剪成直径6 mm 的圆片。测试时,用棉棒蘸取制备好的106 cfu·mL - 1的新鲜金黄色葡萄球菌( 或白色念珠菌) 液体培养物,涂抹在6 mm 厚的营养琼脂平板( 或沙氏琼脂平板) 上,均匀涂抹3 次。把准备好的敷料贴在制备好的平板上,在37 ℃ ( 或25℃) 下培养18 h 后观察有无抑菌环出现。
4、结果
1)温度、摇床转速对金黄色葡萄球菌和白色念珠菌生长的影响:金黄色葡萄球菌振摇1h 前后的差值见表1。烧瓶振荡法通过限制不加样片组1 h振摇前后的菌落数差值要在10%以内,来确保试验过程中不加样片组菌数作为对照菌数量的稳定性。从表1 的试验结果可见,在37 ℃的培养条件下,摇床转速对金黄色葡萄球菌生长有较大的影响: 转速越高,金黄色葡萄球菌1 h 振摇前后的差值越显;25 ℃的试验条件下,摇床转速在300 r·min -1时,振摇前后的差值也容易超过10% 的限制。因此,最佳试验条件将选择在25 ℃,并且转速最好低于300r·min - 1。高的转速更有利于强效抑菌除湿敷料与微生物的接触; 同时,试验时用带有瓶塞的瓶子,会降低正常的氧含量而影响微生物正常的生长,所以通过选择实验条件允许范围内的最大振摇转速可以弥补这样的影响,即优化条件为: 25 ℃, 200r·min - 1。白色念珠菌振摇前后差值见表2。从表2 的试验结果可见,温度及转速在1 h内对白色念珠菌的影响并不明显,可能因为白色念珠菌生长速度较细菌要缓慢。综合试验结果,可以将烧瓶振荡试验的条件定为: 25 ℃, 200 r·min - 1。
2)样品测试结果 通过采用上述优化了的实验条件,对a、b2批样品进行了抗菌性检测。2批样品对金黄色葡萄球菌和白色念珠菌的抗抑菌率见表1 ~ 4。结果显示: 批号为a 的无纺布复合纱布片敷料对金黄色葡萄球菌作用1 h,抗( 抑) 菌率均大于或等于95%;对白色念珠菌作用1 h,抗( 抑) 菌率超过了85%。且不加样片组可以在要求的范围内。批号为b 的无纺布复合纱布片敷料对金黄色葡萄球菌作用1 h,抗( 抑) 菌率均大于80%; 对白色念珠菌作用1 h,抗( 抑) 菌率大于70%。且不加样片组可以在要求的范围内。结果显示,2批敷料对金黄色葡萄球菌作用1 h,抑菌率均大于或等于80%; 对白色念珠菌作用1 h,抑菌率均超过了80%,远远超出了判定标准( 标准规定抑菌率超过26%即为有抑菌作用) 。2批产品表现出良好的抑菌效果。
二、动物实验:
1、材料与方法
1)动物及分组 : 11 周龄 Wi st ar 大鼠
84 只 ,雄性 ,体重 220~250 g ,随机分为 A ( 创面外用 SD 2 Ag 霜剂组 36 只)、 B ( 创面外用本发明敷料 36 只) 3 组。 A、B、两组动物参照第三军医大学动物烧伤模型制作方法均造成 30 % TBSA 浅Ⅱ度烧伤[ 1 ], B、C 两组动物背部创面分别外用 SD 2Ag 霜剂及本发明敷料,包扎并打包固定 ,每天换药 1 次,直至创面愈合。
2)观察指标和方法 : 观察并记录伤后 3 ~14 d 期间创面感染及愈合情况。
3)统计学处理 :实验数据均以 SPSS1010 统计软件进行方差分析 ,结果以x ±s 表示。
通过动物实验,我们认为本发明敷料是一种可生物降解的快速止血抑菌的新型敷料。
Claims (3)
1.一种外科手术用无纺布复合纱布片,包括无纺布片、纱布片、其特征在于:所述无纺布片与纱布片复合,纱布片上复合有竹纤维纱布层和敷料层,所述敷料层由抑菌层、促愈层和止血层复合而成;
所述抑菌层包括苯扎氯铵4~5份、皂甙3~6份、甘草4~8份、丁香2~5份、忍冬藤1~4份、羟丙基纤维素5~8份;
所述促愈层4包含槲皮素5~7份、角蛋白3~8份、聚六亚甲基胍6~9份、甘油2~8份、溶菌酶1.5~5份、三七3~7份、羟丙基纤维素5~8份、远红外陶瓷粉5~9份,所述止血层5包含咖啡酸3~8份、马鞭草苷2~4份、苄丙酮香豆素2.5~5份、白毛茛碱4~7份、羟丙基纤维素5~8份。
2.根据权利要求1所述的外科手术用无纺布复合纱布片,其特征是所述所述无纺布片包括纺粘无纺布层,熔喷无纺布层,所述熔喷无纺布层下设有柔性金属丝网层,所述柔性金属丝网层下复合有纺粘无纺布层,纺粘无纺布层下复合有吸水材料层。
3.根据权利要求2所述的外科手术用无纺布复合纱布片,其特征是所述柔性金属丝网层由棉纤维、聚酯纤维、银丝纤维相互交织而成,其中棉纤维为经线,聚酯纤维、银丝纤维合股后构成纬线与经线编织构成柔性金属丝网层。
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CN105311671A (zh) | 2016-02-10 |
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