CN114808229A - 一种儿童用高强医用缝合线及其制备方法 - Google Patents
一种儿童用高强医用缝合线及其制备方法 Download PDFInfo
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- CN114808229A CN114808229A CN202210577576.9A CN202210577576A CN114808229A CN 114808229 A CN114808229 A CN 114808229A CN 202210577576 A CN202210577576 A CN 202210577576A CN 114808229 A CN114808229 A CN 114808229A
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Abstract
本申请涉及生物医药材料领域,具体公开了一种儿童用高强医用缝合线及其制备方法。儿童用高强医用缝合线的制备方法,包括以下步骤:将壳聚糖纤维放入含有聚乙烯醇和交联剂的溶胀液浸泡交联,轴向拉伸、清洗、干燥,获得增强壳聚糖纤维;将增强壳聚糖纤维浸入海藻酸钠水溶液中,升温至70‑80℃,浸渍6‑8h后,取出增强壳聚糖纤维,冷冻,室温解冻,循环,浸泡在氯化钙溶液中,进行药物负载,加入到壳聚糖乙酸溶液中浸渍,烘干,制得芯层线;按照芯层线和壳层线重量比为0.1‑0.25:1进行编织,壳层线为蚕丝线,将编织线进行定型,辐照灭菌。本申请的儿童用高强医用缝合线其具有力学性能好,有效药物浓度持续时间长,抗菌性优异且易于识别的优点。
Description
技术领域
本申请涉及生物医用材料技术领域,更具体地说,它涉及一种儿童用高强医用缝合线及其制备方法。
背景技术
医用缝合线是最常见的移植类生物医用纺织品,广泛用于临床内外科各类伤口缝合等方面,缝合线需要具备一定的力学性能,包括断裂强力、打结拉伸强度、弯曲强度和耐摩擦性能等,此外缝合线还应具有良好的生物相容性,不易引发伤口部位感染和炎症。
临床上,新生儿置管缝合部位经常出现渗血、红肿,有时候还会出现排斥反应,常用的体外缝合线没有止血、抗菌等功效。儿童尤其是新生儿皮肤娇嫩,缝合部位容易出现红肿,拆线后易留有疤痕。因此儿童用伤口缝合的缝合线,除了具有力学性能,也需具备止血、抑菌、促进伤口愈合、低排斥反应等。
壳聚糖纤维属于天然材料,具有无毒、止血、消炎等优点,与生物细胞有良好的相容性,免疫抗原性小,与体液和细胞不会产生排异反应,可生物降解,在生物体内的降解产物为氨基葡萄糖,氨基葡萄糖对人体无害,在体内不会产生集聚,因而壳聚糖在生物医药领域应用前景十分广泛。
壳聚糖及其衍生物作为组织支架、药物载体等具有促进伤口愈合、防止组织粘连、抗凝血、降脂等作用,常备用于医药缝合线,但受其材质的影响,壳聚糖纤维的力学强度不高,常规纺丝得到的壳聚糖纤维的断裂强度仅为1.07cN/dtex,无法达到医用缝合线的应用要求。
发明内容
为了提高壳聚糖纤维的力学性能,本申请提供一种儿童用高强医用缝合线及其制备方法。
第一方面,本申请提供一种儿童用高强医用缝合线的制备方法,采用如下的技术方案:
一种儿童用高强医用缝合线的制备方法,包括以下步骤:将壳聚糖纤维放入含有聚乙烯醇和交联剂且pH值为6-6.5的溶胀液浸泡交联,轴向拉伸、清洗、干燥,获得增强壳聚糖纤维;将海藻酸钠与水混合,制得海藻酸钠溶液,将增强壳聚糖纤维浸入海藻酸钠水溶液中,升温至70-80℃,浸渍6-8h后,取出增强壳聚糖纤维,置于-(16~20)℃下冷冻20-22h,室温解冻,循环5-6次,浸泡在质量浓度为2-7%的氯化钙溶液中,清洗后浸入药剂中进行药物负载,然后加入到质量浓度为2-5%的壳聚糖乙酸溶液中浸渍,烘干,制得芯层线;
按照芯层线和壳层线重量比为0.1-0.25:1进行编织,壳层线为蚕丝线,得到编织线,将编织线进行定型,辐照灭菌,制得医用缝合线通过采用上述技术方案,由于将壳聚糖纤维在含有聚乙烯醇和交联剂的溶胀液中浸泡并交联,溶胀液能使壳聚糖纤维分子链发生一定程度的解缠,形成溶胀体,降低分子链作用力,提高纤维强度,在溶胀的同时引入聚乙烯醇和交联剂,因壳聚糖纤维分子链上含有大量的氨基,而交联剂能与壳聚糖纤维上的氨基和聚乙烯醇上的羟基交联,形成网络结构,使壳聚糖纤维的机械性能提高。
经浸泡并交联后,将增强壳聚糖纤维与海藻酸钠水溶液混合后反复冻融,在循环冷冻-解冻过程中,聚乙烯醇分子链通过氢键形成交联节点,从而形成三维网络结构,而海藻酸钠分子链穿插在三维网络中,海藻酸钠在于氯化钙中的钙离子交联,形成海藻酸钠网络,两种聚合物网络及分子量具有不同的强度和柔性,其分子链间的作用方式和作用力大小也有所不同,另外,交联后的聚乙烯醇凝胶是一种微晶区和无定形区共存的结构,结晶具有与交联相似的作用,对凝胶的强度起到增强的作用;且在低温冷冻时,壳聚糖纤维中的水不断结冰,凝胶的网络结构与水分离,经真空干燥后,结冰部位的冰升华后形成孔洞,最终得到多孔性的海绵结构。
将具有海绵孔洞结构的壳聚糖纤维浸入药剂中进行药剂负载,然后再将浸有药剂的壳聚糖纤维与壳聚糖乙酸溶液混合,利用正负电荷作用自组装原料,在壳聚糖纤维外层包裹一层能与海藻酸钠提供的阴离子结合的能提供阳离子的壳聚糖,作为外保护层,保护药剂,阻止药剂的快速释放,进一步延缓药物的释放速率;包覆的壳聚糖同时也能对壳聚糖纤维进行上浆,改善壳聚糖纤维表面厚度均匀性。
然后利用制成的壳聚糖纤维作为芯层线,蚕丝线作为壳层线,蚕丝是天然蛋白纤维,具有良好的组织相容性,具有较好的打结弯曲性、柔软性等,被血液浸润时能迅速膨胀,充满针眼,手术缝合质量好,使用蚕丝线作为壳层线,与壳聚糖纤维进行编织,经热定型后,制成的缝合线具有较好的力学强度。
优选的,所述蚕丝线经过以下预处理:
将蚕丝线经脱胶后,置于含有水、氯化钙和乙醇的混合溶液中,升温至45-50℃,恒温处理10-20min,干燥,制得多孔蚕丝线,水、氯化钙和乙醇的质量比1:10-10.2:2.5-2.6;
将纳米二氧化钛-壳聚糖复合材料与薯莨染料、柠檬酸、七水合硫酸亚铁混合,超声1-2h,制得预处理料;
将多孔蚕丝线与预处理料混合,升温至80-85℃,保温25-30min,水洗,干燥。
蚕丝线由氨基酸组成,可为微生物的成长与繁殖提供舒适的温床,虽然缝合线在使用前会经过高温灭菌,但在使用过程中,暴露于空气中的部分蚕丝线仍有机会与细菌接触,引发伤口感染,且普通缝合线为白色,在缝合过程中若有血液附着,不利于辨识,通过采用上述技术方案,将蚕丝线在含有氯化钙等组分的中性钙盐三元体系下,会发生溶解现象,在蚕丝线表面生成微孔穴和原纤化特征,蚕丝线的填充能力有所提高,在微溶过程中,蚕丝线纤维内部部分结构被破坏,分子结合力减少,使得蚕丝线的纤维强力下降;将纳米二氧化钛-壳聚糖、薯莨染料和七水合硫酸亚铁混合后,与经过微溶处理的蚕丝线进行混合浸染。
薯莨染料中的缩合单宁色素在游离亚铁粒子的络合作用下,缩合单宁色素的酚羟基与蚕丝蛋白多肽链上的羰基形成了大量牢固的氢键,这种分子链间的作用使得色素和丝素之间形成物理交联网络结构,从而牢固结合在蚕丝线上,并使蚕丝线的结构更加致密,强力和模量显著提高,抗拉性能得到显著改善,且数量染料对革兰氏阳性菌具有较强的抑菌活性,能破坏细菌细胞膜,抑制细菌生长;纳米二氧化钛-壳聚糖复合材料中存在羟基和氨基等活性基团,在柠檬酸的交联作用下,蚕丝线中丝素分子间以及丝素与壳聚糖大分子间形成共价交联,改善蚕丝线的断裂强度和拉伸率;另外壳聚糖对细菌具有较好的吸附性,能吸附细菌,与构成细胞壁的阴离子相互吸引,束缚细菌的自由度,形成一层高分子膜,阻止营养物质向细胞内运输,另一方面使细胞壁和细胞膜上的负电荷分布不均破坏细胞壁的合成;最后经纳米二氧化钛-壳聚糖复合材料处理后的蚕丝线的染色率和色牢度提升,因在弱酸环境下,壳聚糖中存在的氨基易形成-NH3+离子,从而增加上染率和染色牢度,且纳米二氧化钛-壳聚糖复合材料的加入,能减少编织缝合线的间隙和毛羽,降低摩擦阻力,防止缝合过程中组织的拖拽,引起儿童痛苦。
优选的,所述预处理料中各原料的重量份如下:纳米二氧化钛-壳聚糖复合材料1-2份、柠檬酸0.3-0.5份、薯莨染料0.4-0.8份和七水合硫酸亚铁0.06-0.1份。
通过采用上述技术方案,使用薯莨染料对蚕丝线进行染色,使用柠檬酸控制弱酸环境,从而使得壳聚糖中氨基形成-NH3+离子,改善蚕丝线的断裂强度和染色牢度。
优选的,所述纳米二氧化钛-壳聚糖复合材料由以下方法制成:将20g马来酸酐、壳聚糖、次亚磷酸钠搅拌均匀后过滤,去除滤渣,加入吐温-80和OP-10,室温搅拌均匀后加入纳米二氧化钛溶胶,搅拌均匀。
通过采用上述技术方案,使用吐温-80起到分散作用,OP-10起到乳化作用,两种表面活性剂能起到较好的协同效果,有利于纳米微粒的分散,次亚磷酸钠在起到催化作用,防止温度过高产生含有不饱和双建的衣康酸和乌头酸,导致蚕丝线变色,马来酸酐有助于壳聚糖的溶解,并改善壳聚糖与蚕丝线的交联,且马来酸酐还能使壳聚糖上的氨基与纳米二氧化钛溶胶表面羟基产生较强的氢键作用,有利于纳米微粒的分散。
优选的,所述多孔蚕丝线和预处理料的质量比为1:50-55,升温速度为4-4.5℃/min水洗,干燥温度为80-85℃,时间为3-5h。
通过采用上述技术方案,缓慢升温至80-85℃,能增大薯莨染料的上染率和染色牢度,提高染色质量。
优选的,所述聚乙烯醇、交联剂和壳聚糖纤维的质量比为0.25-0.45:0.01-0.03:1。
通过采用上述技术方案,使聚乙烯醇和壳聚糖纤维充分交联,改善壳聚糖纤维的力学强度。
优选的,所述轴向拉伸的张力为80~350cN,拉伸温度为25~40℃,拉伸倍数为1.1~1.9倍,拉伸时间为1~3h。
通过采用上述技术方案,在溶胀状态下,壳聚糖纤维内部充满液体,减小了大分子链和链段的运动阻力,在适度的拉伸下,大分子及链段沿拉伸方向取向,从而使得纤维强度不断提高。
优选的,所述溶胀液为稀醋酸、稀盐酸、草酸和柠檬酸中的一种或几种的混合物,浸泡交联温度为40-50℃,时间为1-3h;
清洗为用去离子水浸泡0.5-1h,干燥温度为60-80℃,时间为3-4h。
通过采用上述技术方案,醋酸等作为壳聚糖的溶胀剂,只溶胀不溶解,使壳聚糖纤维分子间作用力减弱,处于拉伸状态,分子链结晶度随着轴向拉伸的外张力增大而增大,结晶趋于完整,提高了壳聚糖纤维的强度和模量。
优选的,所述交联剂为戊二醛或乙二醛。
通过采用上述技术方案,戊二醛或乙二醛能与壳聚糖纤维产生交联反应,且乙二醛中的两对羰基直接相连,对交联点没有束缚,能提高壳聚糖纤维的强度。
优选的,药剂为激素类药剂、消炎止痛类药剂,抗过敏类药剂,抗感染类药剂、免疫调节类药剂、抗增生类药剂、神经镇静与神经衰弱治疗类药剂中的一种。
第二方面,本申请提供一种儿童用高强医用缝合线,采用如下的技术方案:
一种儿童用高强医用缝合线,由儿童用高强医用缝合线的制备方法制成。
通过采用上述技术方案,制成的缝合线的力学强度高,具有较好的打结弯曲性和拉扯强度,不易断裂,且具有较好的缓释效果和抗菌效果。
综上所述,本申请具有以下有益效果:
1、本申请的方法,通过将壳聚糖纤维在溶胀时交联,使壳聚糖纤维与聚乙烯醇产生交联网络,改善壳聚糖纤维的力学强度,然后再将壳聚糖纤维与海藻酸钠溶液经过反复冻融,与氯化钙粒子进行交联,从而形成聚乙烯醇和海藻酸钠的互穿网络,同时在反复冻融过程中形成多孔结构,增大壳聚糖纤维的载药量,然后再包覆壳聚糖乙酸溶液,经固化后壳聚糖在壳聚糖纤维上形成保护层,延长药剂缓释效果,同时壳聚糖能降低壳聚糖纤维的毛羽,减轻手术过程中拉扯和拖拽对儿童产生的痛苦。
2、本申请中优选使用蚕丝线作为壳层线,蚕丝线与具有良好的组织相容性,且打结性能好,吸湿性优异,编织制成的缝合线的力学强度得到改善。
3、本申请中优选将蚕丝线进行微溶处理,在蚕丝线表面形成微孔穴,提高其填充能力,然后在其表面填充纳米二氧化钛-壳聚糖复合材料,纳米二氧化钛能填充微孔,防止纤维强力下降,壳聚糖在弱酸环境下,能改善蚕丝线的抗菌性和力学强度,同时纳米二氧化钛-壳聚糖能降低蚕丝线表面毛羽,降低手术工程中儿童的痛苦;同时使用薯莨染料进行染色和抗菌性提升,便于手术过程中缝合线的识别。
附图说明
图1为实施例1和4、对比例2、3和5制备的缝合线的药物释放曲线图。
具体实施方式
实施例
以下实施例中各原料均可由市售获得,以如下市售原料为例,壳聚糖纤维选自青岛即发集团股份有限公司,纱支为40S;聚乙烯醇选自上海鸿时实业有限公司,型号为NJ-II,货号为HS0002;纳米二氧化钛溶胶选自宣城晶瑞新材料有限公司,型号为VK-TA33;吐温-80选自江苏省海安石油化工厂,货号为T-80;OP-10选自济南鑫诺化工有限公司;壳聚糖选自青岛弘海生物技术有限公司,货号为043。
实施例1:一种儿童用高强医用缝合线的制备方法,包括以下步骤:
S1、将壳聚糖纤维放入含有聚乙烯醇和交联剂且pH值为6的溶胀液浸泡交联,轴向拉伸,用去离子水浸泡0.5h,在60℃下干燥4h,获得增强壳聚糖纤维,溶胀液为稀醋酸,聚乙烯醇、交联剂和壳聚糖纤维的质量比为0.25:0.01:1,交联剂为乙二醛,乙二醛在稀醋酸中含量为1%,聚乙烯醇在稀醋酸中的含量为25%,浸泡交联温度为40℃,时间为3h,轴向拉伸张力为80cN,拉伸温度为25℃,拉伸倍数为1.1倍,拉伸时间为3h;
S2、将海藻酸钠与水混合,制得质量浓度为3%的海藻酸钠溶液,将增强壳聚糖纤维浸入海藻酸钠水溶液中,升温至70℃,浸渍8h后,取出增强壳聚糖纤维,置于-16℃下冷冻22h,室温解冻,循环5次后,浸泡在质量浓度为2%的氯化钙溶液中,清洗后浸入紫杉醇中,在30℃下药物负载2h;
S3、将负载紫杉醇的增强壳聚糖纤维加入到质量浓度为2%的壳聚糖乙酸溶液中浸渍,45℃下烘干,制得芯层线;
S4、按照芯层线和壳层线重量比为0.1:1进行编织,壳层线为单股的蚕丝线,齿轮比为81/36,编织速度为100rpm,得到线径为0.22mm的编织线,将编织线在90℃下热定型30min,采用Co60辐照灭菌,制得医用缝合线。
实施例2:一种儿童用高强医用缝合线的制备方法,包括以下步骤:
S1、将壳聚糖纤维放入含有聚乙烯醇和交联剂且pH值为6.5的溶胀液浸泡交联,轴向拉伸,用去离子水浸泡1h,在80℃下干燥3h,获得增强壳聚糖纤维,溶胀液为柠檬酸,聚乙烯醇、交联剂和壳聚糖纤维的质量比为0.45:0.03:1,交联剂为戊二醛,戊二醛在柠檬酸中含量为3%,聚乙烯醇在稀醋酸中的含量为45%,浸泡交联温度为50℃,时间为1h,轴向拉伸张力为350cN,拉伸温度为40℃,拉伸倍数为1.9倍,拉伸时间为1h;
S2、将海藻酸钠与水混合,制得质量浓度为3%的海藻酸钠溶液,将增强壳聚糖纤维浸入海藻酸钠水溶液中,升温至80℃,浸渍6h后,取出增强壳聚糖纤维,置于-20℃下冷冻20h,室温解冻,循环6次后,浸泡在质量浓度为7%的氯化钙溶液中,清洗后浸入紫杉醇中,在40℃下药物负载2h;
S3、将负载紫杉醇的增强壳聚糖纤维加入到质量浓度为5%的壳聚糖乙酸溶液中浸渍,45℃下烘干,制得芯层线;
S4、按照芯层线和壳层线重量比为0.25:1进行编织,壳层线为单股的蚕丝线,齿轮比为81/36,编织速度为100rpm,得到线径为0.22mm的编织线,将编织线在90℃下热定型30min,采用Co60辐照灭菌,制得医用缝合线。
实施例3:一种儿童用高强医用缝合线的制备方法,包括以下步骤:
S1、将壳聚糖纤维放入含有聚乙烯醇和交联剂且pH值为6.3的溶胀液浸泡交联,轴向拉伸,用去离子水浸泡1h,在80℃下干燥3h,获得增强壳聚糖纤维,溶胀液为柠檬酸,聚乙烯醇、交联剂和壳聚糖纤维的质量比为0.35:0.02:1,交联剂为戊二醛,戊二醛在柠檬酸中含量为2%,聚乙烯醇在稀醋酸中的含量为35%,浸泡交联温度为50℃,时间为2h,轴向拉伸张力为200cN,拉伸温度为30℃,拉伸倍数为1.5倍,拉伸时间为2h;
S2、将海藻酸钠与水混合,制得质量浓度为3%的海藻酸钠溶液,将增强壳聚糖纤维浸入海藻酸钠水溶液中,升温至80℃,浸渍6h后,取出增强壳聚糖纤维,置于-18℃下冷冻20h,室温解冻,循环6次后,浸泡在质量浓度为5%的氯化钙溶液中,清洗后浸入紫杉醇中,在40℃下药物负载2h;
S3、将负载紫杉醇的增强壳聚糖纤维加入到质量浓度为5%的壳聚糖乙酸溶液中浸渍,45℃下烘干,制得芯层线;
S4、按照芯层线和壳层线重量比为0.15:1进行编织,壳层线为单股的蚕丝线,齿轮比为81/36,编织速度为100rpm,得到线径为0.22mm的编织线,将编织线在90℃下热定型30min,采用Co60辐照灭菌,制得医用缝合线。
实施例4:一种儿童用高强医用缝合线的制备方法,与实施例1的区别在于,蚕丝线经过以下预处理:
(1)将蚕丝线置于浓度为1g/L的碳酸氢钠溶液中煮沸20min,重复3次进行脱胶,将脱胶后的蚕丝线置于含有水、氯化钙和乙醇的混合溶液中,升温至45℃,恒温处理20min,干燥,制得多孔蚕丝线,水、氯化钙和乙醇的质量比1:10:2.5;
(2)将1kg纳米二氧化钛-壳聚糖复合材料与0.3kg柠檬酸、0.4kg薯莨染料、0.06kg七水合硫酸亚铁混合,超声1h,制得预处理料;纳米二氧化钛-壳聚糖复合材料的制备方法为:将20g马来酸酐、10g壳聚糖、30g次亚磷酸钠加入到1g的去离子水中,搅拌均匀后过滤,去除滤渣,加入0.5g吐温-80和0.1g OP-10,室温搅拌均匀后加入纳米二氧化钛溶胶,使二氧化钛浓度为5g/L,搅拌分散30min;
(3)将多孔蚕丝线与预处理料按照1:50的质量比混合,以4℃/min的升温速率升温至80℃,保温30min,水洗,在80℃下干燥5h。
实施例5:一种儿童用高强医用缝合线的制备方法,与实施例1的区别在于,蚕丝线经过以下预处理:
(1)将蚕丝线置于浓度为1g/L的碳酸氢钠溶液中煮沸20min,重复3次进行脱胶,将脱胶后的蚕丝线置于含有水、氯化钙和乙醇的混合溶液中,升温至50℃,恒温处理10min,干燥,制得多孔蚕丝线,水、氯化钙和乙醇的质量比1:10.2:2.6;
(2)将2kg纳米二氧化钛-壳聚糖复合材料与0.5kg柠檬酸、0.8kg薯莨染料、0.1kg七水合硫酸亚铁混合,超声2h,制得预处理料;纳米二氧化钛-壳聚糖复合材料的制备方法为:将20g马来酸酐、10g壳聚糖、30g次亚磷酸钠加入到1g的去离子水中,搅拌均匀后过滤,去除滤渣,加入0.5g吐温-80和0.1g OP-10,室温搅拌均匀后加入纳米二氧化钛溶胶,使二氧化钛浓度为5g/L,搅拌分散30min;
(3)将多孔蚕丝线与预处理料按照1:55的质量比混合,以4.5℃/min的升温速率升温至85℃,保温30min,水洗,在85℃下干燥3h。
实施例6:一种儿童用高强医用缝合线的制备方法,与实施例1的区别在于,蚕丝线经过以下预处理:
(1)将2kg纳米二氧化钛-壳聚糖复合材料与0.8kg薯莨染料、0.1kg七水合硫酸亚铁混合,超声2h,制得预处理料;纳米二氧化钛-壳聚糖复合材料的制备方法为:将20g柠檬酸、10g壳聚糖、30g次亚磷酸钠加入到1g的去离子水中,搅拌均匀后过滤,去除滤渣,加入0.5g吐温-80和0.1g OP-10,室温搅拌均匀后加入纳米二氧化钛溶胶,使二氧化钛浓度为5g/L,搅拌分散30min;
(2)将蚕丝线与预处理料按照1:55的质量比混合,以4.5℃/min的升温速率升温至85℃,保温30min,水洗,在85℃下干燥3h。
实施例7:一种儿童用高强医用缝合线的制备方法,与实施例5的区别在于,蚕丝线预处理时,步骤(2)中预处理料中未添加纳米二氧化钛-壳聚糖复合材料。
实施例8:一种儿童用高强医用缝合线的制备方法,与实施例5的区别在于,蚕丝线预处理时,步骤(2)中预处理料中使用等量二氧化钛替代纳米二氧化钛-壳聚糖复合材料。
实施例9:一种儿童用高强医用缝合线的制备方法,与实施例5的区别在于,蚕丝线预处理时,使用等量高粱红天然染料替代薯莨染料。
实施例10:一种儿童用高强医用缝合线的制备方法,与实施例5的区别在于,蚕丝预处理时,步骤(3)为将蚕丝线和预处理料在室温下浸轧,轧余率为70%。
对比例
对比例1:一种儿童用高强医用缝合线的制备方法,与实施例1的区别在于,溶胀液中不含聚乙烯醇和交联剂。
对比例2:一种儿童用高强医用缝合线的制备方法,与实施例1的区别在于,步骤S2中未将负载药剂的增强壳聚糖纤维浸渍在壳聚糖乙酸溶液中。
对比例3:一种儿童用高强医用缝合线的制备方法,与实施例1的区别在于,步骤S2中,将浸渍海藻酸钠水溶液的增强壳聚糖纤维在45℃下干燥后浸泡在氯化钙溶液中。
对比例4:一种儿童用高强医用缝合线的制备方法,与实施例1的区别在于,壳层线为壳聚糖纤维。
对比例5:一种载药种载药高强医用缝合线的制备方法,步骤如下:
(1)改性中空二氧化硅亚微米球的制备:将中空二氧化硅亚微米球加入乙醇中,以400W的功率超声并在300rpm的转速下搅拌均匀制得分散液;将硅烷偶联剂KH560溶于乙醇水溶液中,在20℃,300rpm的转速下搅拌反应制得水解液;将水解液加入分散液中,在50℃,300rpm的转速下反应3h后,在80℃下旋蒸2h,再经洗涤得到改性中空二氧化硅亚微米球;
(2)负载改性中空二氧化硅亚微米球:将壳聚糖纤维制成品(经湿法纺丝成形的壳聚糖纤维)在75℃进行预先烘干处理1.5h,然后完全浸没于装有pH为6.3的分散有改性中空二氧化硅亚微米球的稀醋酸中,接着在张力为210cN,拉伸温度为40℃,拉伸倍数为1.5的条件下轴向拉伸1h,最后将拉伸后的纤维放入去离子水中浸泡0.8h后在70℃烘干干燥,即获得负载改性中空二氧化硅亚微米球的壳聚糖纤维;
(3)药物负载:将负载改性中空二氧化硅亚微米球的壳聚糖纤维浸入紫杉醇中在20℃下负载0.5h,获得载药壳聚糖纤维;
(4)纤维上浆:将羧甲基壳聚糖在200rpm的速度下搅拌溶解于水后,经真空脱泡处理制得交联羧甲基壳聚糖上浆剂,其中羧甲基壳聚糖和水的质量比为3:120;再将步骤(3)中制得的载药壳聚糖纤维浸入交联羧甲基壳聚糖上浆剂中均匀上浆后在55℃的温度下烘干,再将上浆后的壳聚糖纤维浸入浓度为3wt%的硫酸氢钙水溶液中交联8min,在55℃的温度下烘干制得羧甲基壳聚糖上浆载药壳聚糖纤维;
(5)载药高强医用缝合线的制备:将羧甲基壳聚糖上浆载药壳聚糖纤维淋涂着色剂后烘干,再浸入医用酒精30min,最终真空干燥包装即得载药高强医用缝合线。
性能检测试验
一、力学强度和抗菌性检测:按照各实施例和对比例中方法制备医用缝合线,以壳聚糖纤维作为空白组,按照下列方法检测医用缝合线的性能,将检测结果记录于表1中。
1、断裂强度和伸长率:将各样品置于恒温(25℃)恒湿(相对湿度65℃)平衡48h后测试采用XLW型医用缝合线测定仪工作长度250mm,预加张力为0.05cN/detx,拉伸速度为250mm/min,试验次数为10次,取平均值。
2、抑菌率:选择用大肠杆菌和金黄色葡萄球菌作为测试菌种,结合ASTM E2149中振荡烧瓶法和FZ/T73023-2006《抗菌针织品》标准进行测试。
表1儿童用高强医用缝合线的力学强度和抗菌性检测
实施例1-3中采用不同工艺参数制备医用缝合线,缝合线的断裂强度达到3.57cN/dtex以上,且断裂伸长率达到13.78%以上,均高于空白组的壳聚糖纤维,但与壳聚糖纤维相比,因加入蚕丝线,其抗菌性有所下降。
实施例4-5中对蚕丝线进行了预处理,制成的缝合线的力学强度有所增加,且对大肠杆菌和金黄色葡萄球菌的抗菌性增减显著。
实施例6中因未使用氯化钙等对蚕丝线进行原纤化处理,缝合线的断裂强度、断裂伸长率等与实施例5相差不大,但其抗菌性显著降低,说明对蚕丝线进行原纤化,能增强抗菌性。
实施例7中预处理蚕丝线时,对蚕丝线进行原纤化后,预处理料中未添加纳米二氧化钛-壳聚糖复合材料,与实施例5相比,缝合线的断裂强度、断裂伸长率等力学性能有所降低,且对大肠杆菌和金黄色葡萄球菌的抑菌率有所下降,说明纳米二氧化钛-壳聚糖复合材料能增加原纤化后蚕丝线的力学强度,并同时改善蚕丝线的抗菌性能。
实施例8中预处理蚕丝线时,使用等量的二氧化钛替代纳米二氧化钛-壳聚糖复合材料,与实施例5相比,缝合线的力学强度下降,且抗菌性减弱,与未添加纳米二氧化钛-壳聚糖复合材料的实施例7相比,预处理料中加入二氧化钛,对缝合线的力学强度和抗菌性影响力度均不如纳米二氧化钛-壳聚糖复合材料。
实施例9中预处理蚕丝线时,使用高粱红染料替代薯莨染料,与实施例5相比,缝合线的断裂强度、断裂伸长率等均相差不大,但对大肠杆菌和金黄色葡萄球菌的抑菌率显著下降,说明使用薯莨染料能改善缝合线的抑菌性。
实施例10中将蚕丝线和预处理料在室温下浸渍进行复合,与实施例5相比,缝合线的力学强度检测结果相似,但抑菌率有所降低。
对比例1与实施例1相比,未添加聚乙烯醇和交联剂,表1内数据显示,缝合线的断裂强度和断裂伸长率与实施例1相差显著,说明聚乙烯醇和交联剂能改善壳聚糖纤维的力学性能。
对比例2中未将负载药剂的增强壳聚糖纤维与壳聚糖乙酸溶液混合浸渍,对比例2制成的风险的断裂强度和断裂伸长率比对比例1有所增大,但仍不及实施例1,说明壳聚糖乙酸溶液能改善缝合线的力学性能。
对比例3中未将浸渍海藻酸钠水溶液的增强壳聚糖纤维进行冻融循环,表1内显示,对比例3制备的缝合线与实施例1的力学强度相差不大,且具有相似的抗菌效果。
对比例4中使用壳聚糖纤维替代蚕丝线作为壳层线,同时使用壳聚糖纤维作为缝合线的芯层线和壳层线,与实施例1相比,缝合线的断裂强度下降,断裂伸长率降低,力学性能减弱,但抗菌性有所增大。
对比例5为现有技术制备的缝合线,断裂强度和断裂伸长率均小于实施例1,力学强度不及本申请,但其抗菌率高,抑菌效果好。
二、药剂缓释性能:将实施例1、实施例4、对比例2、对比例3和对比例5中制备的缝合线,放入20mL蒸馏水中,在37℃下恒温振荡,振频为65次/分,每24小时换一次溶液,用高效液相色谱仪测试溶液中的药物含量,如图1所示。
结合图1中数据可以看出,实施例1制成的缝合线的释药效果明显,且后期释放趋于平稳,在50天时仍在2ug/mL以上,具有良好的缓释控药性能;实施例4中对蚕丝线进行预处理后,药剂的缓释速度有所增大,因蚕丝线上具有多孔结构,使得药剂释放路径增多,释放速度增大;对比例2因负载药剂的增强壳聚糖纤维未浸渍壳聚糖乙酸溶液,未对负载药剂的增强壳聚糖纤维进行药剂稳定性处理,药物在20天内快速降低,在20天时趋于平衡;对比例3中将增强壳聚糖纤维浸渍海藻酸钠水溶液后未进行冻融,图1中可见,对比例3中药剂的初始浓度较低,可能因为未冻融处理的增强壳聚糖纤维中无法形成负载药剂的孔隙,因此药剂负载量较低,且在较短时间内趋于平衡;对比例5为现有技术制备的一种载药缝合线,在45天时,其药物浓度低于2ug/mL,缓释效果不及实施例1。
三、缝合线的上染率和色牢度:取实施例4-10制备的缝合线,按照以下方法检测缝合线的染色性能,将检测结果记录于表2中。
1、上染率:将染色前的预处理料、染色后的预处理料残液分别稀释相同的体积,测试其吸光度,上染率按照下式计算:上染率(%)=(1-染色前预处理料的吸光度/染色后预处理料的吸光度)×100%;
2、摩擦色牢度:按照GB/T3920-1997进行检测,采用Y151型染色摩擦牢度计测定后根据△E评级。
表2实施例4-10制成的医用缝合线的染色性检测
项目 | 上染率/% | 干摩擦色牢度 | 湿摩擦色牢度 |
实施例4 | 87.6 | 5 | 5 |
实施例5 | 88.5 | 5 | 5 |
实施例6 | 72.5 | 4-5 | 4-5 |
实施例7 | 68.5 | 4 | 4 |
实施例8 | 70.1 | 4-5 | 4-5 |
实施例9 | 74.8 | 5 | 4-5 |
实施例10 | 62.4 | 4 | 4 |
实施例4和实施例5中对蚕丝线进行预处理,表2内显示缝合线的上染率达到87%以上,且染色牢度高,经摩擦后不易脱色。
实施例6中未对蚕丝线进行原纤化,缝合线的上染率有所降低,且摩擦色牢度降低;实施例7中未添加纳米二氧化钛-壳聚糖复合材料,缝合线的上染率有所降低,且摩擦色牢度减弱;实施例8中使用等量二氧化钛替代纳米二氧化钛-壳聚糖复合材料,制成的缝合线的上染率不及实施例4;实施例9中使用等量的高粱红染料替代薯莨染料,上染率低,色牢度差异不大;实施例10中使用浸轧的方法对蚕丝线进行染色,上染率低,且摩擦色牢度差。
本具体实施例仅仅是对本申请的解释,其并不是对本申请的限制,本领域技术人员在阅读完本说明书后可以根据需要对本实施例做出没有创造性贡献的修改,但只要在本申请的权利要求范围内都受到专利法的保护。
Claims (10)
1.一种儿童用高强医用缝合线的制备方法,其特征在于,包括以下步骤:
将壳聚糖纤维放入含有聚乙烯醇和交联剂且pH值为6-6.5的溶胀液浸泡交联,轴向拉伸、清洗、干燥,获得增强壳聚糖纤维;
将海藻酸钠与水混合,制得海藻酸钠溶液,将增强壳聚糖纤维浸入海藻酸钠水溶液中,升温至70-80℃,浸渍6-8h后,取出增强壳聚糖纤维,置于-(16~20)℃下冷冻20-22h,室温解冻,循环5-6次,浸泡在质量浓度为2-7%的氯化钙溶液中,清洗后浸入药剂中进行药物负载,然后加入到质量浓度为2-5%的壳聚糖乙酸溶液中浸渍,烘干,制得芯层线;
按照芯层线和壳层线重量比为0.1-0.25:1进行编织,壳层线为蚕丝线,得到编织线,将编织线进行定型,辐照灭菌,制得医用缝合线。
2.根据权利要求1所述的儿童用高强医用缝合线的制备方法,其特征在于:所述蚕丝线经过以下预处理:
将蚕丝线经脱胶后,置于含有水、氯化钙和乙醇的混合溶液中,升温至45-50℃,恒温处理10-20min,干燥,制得多孔蚕丝线,水、氯化钙和乙醇的质量比1:10-10.2:2.5-2.6;
将纳米二氧化钛-壳聚糖复合材料与薯莨染料、柠檬酸、七水合硫酸亚铁混合,超声1-2h,制得预处理料;
将多孔蚕丝线与预处理料混合,升温至80-85℃,保温25-30min,水洗,干燥。
3.根据权利要求2所述的儿童用高强医用缝合线的制备方法,其特征在于,所述预处理料中各原料的重量份如下:纳米二氧化钛-壳聚糖复合材料1-2份、柠檬酸0.3-0.5份、薯莨染料0.4-0.8份和七水合硫酸亚铁0.06-0.1份。
4.根据权利要求2所述的儿童用高强医用缝合线的制备方法,其特征在于,所述纳米二氧化钛-壳聚糖复合材料由以下方法制成:将马来酸酐、壳聚糖、次亚磷酸钠搅拌均匀后过滤,去除滤渣,加入吐温-80和OP-10,室温搅拌均匀后加入纳米二氧化钛溶胶,搅拌均匀。
5.根据权利要求2所述的儿童用高强医用缝合线的制备方法,其特征在于,所述多孔蚕丝线和预处理料的质量比为1:50-55,升温速度为4-4.5℃/min,干燥温度为80-85℃,时间为3-5h。
6.根据权利要求1所述的儿童用高强医用缝合线的制备方法,其特征在于,所述聚乙烯醇、交联剂和壳聚糖纤维的质量比为0.25-0.45:0.01-0.03:1。
7.根据权利要求1所述的儿童用高强医用缝合线的制备方法,其特征在于,所述轴向拉伸的张力为80~350cN,拉伸温度为25~40℃,拉伸倍数为1.1~1.9倍,拉伸时间为1~3h。
8.根据权利要求1所述的儿童用高强医用缝合线的制备方法,其特征在于,所述溶胀液为稀醋酸、稀盐酸、草酸和柠檬酸中的一种或几种的混合物;浸泡交联温度为40-50℃,时间为1-3h;
清洗为用去离子水浸泡0.5-1h,干燥温度为60-80℃,时间为3-4h。
9.根据权利要求1所述的儿童用高强医用缝合线的制备方法,其特征在于,所述交联剂为戊二醛或乙二醛。
10.一种儿童用高强医用缝合线,其特征在于,由权利要求1-9任一项所述的儿童用高强医用缝合线的制备方法制成。
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CN116103922A (zh) * | 2023-04-13 | 2023-05-12 | 江苏德利恒棉业有限公司 | 一种吸汗透气的弹力牛仔布及其制备工艺 |
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CN116103922A (zh) * | 2023-04-13 | 2023-05-12 | 江苏德利恒棉业有限公司 | 一种吸汗透气的弹力牛仔布及其制备工艺 |
CN116103922B (zh) * | 2023-04-13 | 2023-06-20 | 江苏德利恒棉业有限公司 | 一种吸汗透气的弹力牛仔布及其制备工艺 |
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