CN114788901A - 一种含碘手术膜及其制备方法 - Google Patents
一种含碘手术膜及其制备方法 Download PDFInfo
- Publication number
- CN114788901A CN114788901A CN202210724113.0A CN202210724113A CN114788901A CN 114788901 A CN114788901 A CN 114788901A CN 202210724113 A CN202210724113 A CN 202210724113A CN 114788901 A CN114788901 A CN 114788901A
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- CN
- China
- Prior art keywords
- solution
- iodine
- membrane
- parts
- gelatin
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
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- YZPNFYQRPJKWFJ-UHFFFAOYSA-N 2-methyl-1h-imidazol-1-ium;chloride Chemical compound Cl.CC1=NC=CN1 YZPNFYQRPJKWFJ-UHFFFAOYSA-N 0.000 description 1
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- 230000000149 penetrating effect Effects 0.000 description 1
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Classifications
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- Ceramic Engineering (AREA)
- Biomedical Technology (AREA)
- Molecular Biology (AREA)
- Thermal Sciences (AREA)
- Materials For Medical Uses (AREA)
Abstract
本发明公开了一种含碘手术膜及其制备方法,涉及医疗器械技术领域,本发明之手术膜包括以下质量份数配比的原料:壳聚糖15‑35份、明胶20‑40份、乙醇15‑35份、甘油6‑12份、海藻酸钠5‑15份、丁香油1‑3份、胶原蛋白4‑12份、碘1‑5份、聚己内酯8‑40份、明胶2‑10份、埃洛石纳米管0.6‑3份和醋酸0.1‑0.5份。本发明为一种含碘手术膜及其制备方法,纤维素和壳聚糖可以形成较强的氢键作用,二者结合紧密,使第一丝芯既具有较高的机械强度,同时又保持较高的透明性,并且埃洛石纳米管可以帮助载药的纤维膜能够更长久的持续释放药物,延缓药物释放时间,释放的药物能够有效的抑制细菌的繁殖。
Description
技术领域
本发明涉及医疗器械技术领域,特别涉及一种含碘手术膜及其制备方法。
背景技术
控制医院感染是一个不可忽视的问题,目前外科手术部位切口的感染仍以预防为主,除了加强外科手术的无菌操作之外,预防性应用抗菌药物已得到广泛共识。但全身应用抗菌药物的不良反应较多,且手术切口局部的血药浓度较低,难以杀灭附着在手术切口的细菌,因此,选择既能创造无菌区域,又有抗菌作用的新型薄膜保护手术切口,预防切口感染是我们工作的重点。
含碘手术薄膜,是将碘离子附着于医用薄膜上,制成各种规格的新型抗菌薄膜,保护手术位置附近的皮肤,从而形成一个无菌手术区域,并对切口位置有一个持续的抗菌作用;使用后,手术切口的细菌种类和数量明显减少,手术部位感染发生率降低;从研究的结果证实,含碘手术薄膜具有持续抗菌作用。
目前市场上的手术膜进行一定的改进,在手术膜内部添加碘单质,利用碘单质提高手术膜的抗菌功能,但是手术膜的阻隔性和光学透射性决定了手术膜的抗菌性能。
现有手术膜的阻隔性较强,光学透射性较差,这样导致难以看清手术膜下面的皮肤,并且碘单质在工作时难易挥发,导致抗菌性能较弱,并且在使用手术膜时,碘单质没有具体的介质带动工作和挥发,导致大量的碘单质被浪费,没有完成抑菌工作,导致手术膜的适用性较差。
发明内容
本发明的主要目的在于提供一种含碘手术膜及其制备方法,可以有效解决背景技术中现有手术膜的阻隔性较强,光学透射性较差,这样导致难以看清手术膜下面的皮肤,并且碘单质在工作时难易挥发,导致抗菌性能较弱,并且在使用手术膜时,碘单质没有具体的介质带动工作和挥发,导致大量的碘单质被浪费,没有完成抑菌工作,导致手术膜的适用性较差的问题。
为实现上述目的,本发明采取的技术方案为:本发明之一种含碘手术膜,其特征在于:包括第一纤维丝和第二纤维丝组成的纤维膜;以及覆盖在纤维膜上表面的与纤维膜同尺寸的壳聚糖-明胶复合膜;所述壳聚糖-明胶复合膜包括壳聚糖、明胶、乙醇和甘油,所述壳聚糖、明胶、乙醇和甘油的质量份分别为15-35份、20-40份、15-35份、6-12份;
所述第一纤维丝包括丝皮和第一丝芯,所述丝皮包括海藻酸钠、丁香油和胶原蛋白,所述海藻酸钠、丁香油和胶原蛋白的质量份为5-15份、1-3份和4-12份;
所述第一丝芯包括纤维素、壳聚糖乙酸和甲基咪唑氯盐离子液体,所述纤维素和甲基咪唑氯盐离子液体的质量比为1:19,且所述壳聚糖乙酸溶液的浓度为3wt%-7wt%;
所述第二纤维丝包括丝皮和含碘的第二丝芯,所述第二丝芯包括碘、醋酸、聚己内酯、明胶、三氟乙醇和埃洛石纳米管,所述碘、聚己内酯、明胶、埃洛石纳米管和醋酸的质量份分别为1-5份、8-40份、2-10份、0.6-3份和0.1-0.5份。
优选地,所述埃洛石纳米管需要使用甲醇清洗,所述埃洛石纳米管的直径为50nm,长度为60nm。
优选地,所述碘单质被研磨成碘颗粒,加入到甲醇中,搅拌溶解得到其饱和溶液A。
一种含碘手术膜的制备方法,其特征在于:包括以下步骤:
制备含壳聚糖、明胶、乙醇和甘油的壳聚糖-明胶复合膜;
制备含海藻酸钠、丁香油和胶原蛋白的第一纺丝液;
制备含纤维素和壳聚糖的第二纺丝液;
制备含碘的第三纺丝液;
将第一纺丝液作为纺织丝皮丝皮的外层注射液,第二纺丝液作为纺织第一纤维丝的内层注射液,第三纺丝液作为纺织第二纤维丝的内层注射液,使第一纤维丝和第二纤维丝形成纤维膜;
在所述纤维膜上覆盖壳聚糖-明胶复合膜,获得含碘手术膜。
优选地,所述制备壳聚糖-明胶复合膜的步骤包括:
将壳聚糖溶于1wt%的乙酸溶液中,在30℃下磁力搅拌使其溶解;
同时配制适当浓度的明胶溶液,在55℃~60℃下水浴加热使其溶解;
将壳聚糖溶液与明胶溶液按6∶4的体积比混合,并加入0.3wt%的甘油作为增塑剂,在30℃下磁力搅拌20min,然后超声脱气30min备用;
用量筒量取50ml膜液倒在底面光滑的培养皿中,置于60℃的干燥箱中干燥24h,干燥完毕将培养皿置于温度22℃的环境下过夜,然后揭膜并将膜样置于硅胶干燥器中平衡2h后备用。
优选地,制备所述第一纺丝液的具体步骤如下:将海藻酸纳、丁香油和胶原蛋白分别置于40℃以下的蒸馏水中,搅拌直至混合均匀,获得第一纺丝液。
优选地,制备所述第二纺丝液的具体步骤如下:称取2.5g纤维素加入到47.5g甲基咪唑氯盐离子液体中,在80℃的环境下,机械搅拌下至完全溶解,制备浓度为5wt%的纤维素溶液,然后将其倒在玻璃板上流延成型,以水做凝固剂制备出再生纤维素膜,随后将湿态再生纤维素膜分别放入浓度3wt%-7wt%的壳聚糖乙酸溶液中浸泡2h,即可获得第二纺丝液。
优选地,所述制备第三纺丝液的具体步骤如下:
将碘单质进行预研磨,获得D90≤6.0μm的碘颗粒;
取一定量的研磨完毕的碘颗粒加入到甲醇中,搅拌使其溶解以得到其饱和溶液A;
取一定量埃洛石纳米管与溶液A混合,超声分散得到埃洛石纳米管的悬浮液B:
将悬浮液B抽真空直至液体表面不再有气泡出现,重复抽真空步骤3次,得到最高的药物载药量;
离心后取出上清液,用甲醇清洗沉淀除去未吸进纳米管内的药物,即可得到载有碘颗粒的埃洛石纳米管;
分别称取一定量的聚己内酯颗粒和明胶粉末,分别溶于三氟乙醇溶液中,磁力搅拌24h,得到均一的聚己内酯溶液和明胶溶液;
将聚己内酯与明胶溶液以体积比80:20的比例混合后,加入微量的醋酸,搅拌6h后得到透明均一的聚合物溶液,聚己内酯、明胶和醋酸反应生成的聚合物占聚合物溶液的质量百分比为6wt%,在聚合物溶液中分别加入相对于聚合物质量20%的埃洛石纳米管,进而得到第三纺丝液。
优选地,所述在纤维膜上覆盖壳聚糖-明胶复合膜的具体步骤如下:将纤维膜在70-130℃环境下固化2min后,将壳聚糖-明胶复合膜覆盖在纤维膜上,用辊压机在施加130-170N的力下进行辊压,辊压后纤维膜会转移到壳聚糖-明胶复合膜上,然后获得含碘手术膜。
与现有技术相比,本发明具有如下有益效果:
1.本发明中,由于纤维素和壳聚糖可以形成较强的氢键作用,二者结合紧密,使第一丝芯既具有较高的机械强度,同时又保持较高的透明性,壳聚糖的引入,能显著地提高手术膜的抗菌性能。
2.本发明中,利用丝皮对丝芯进行了适当包覆,降低了手术膜使用时的刺激性,同时具有丝芯缓释作用,使手术膜具有长效抗菌功能。
3.本发明中,通过将悬浮液B抽真空直至液体表面不再有气泡出现,重复抽真空步骤3次,随后离心取出上清液,用甲醇清洗沉淀除去未吸进纳米管内的药物,即可得到载有碘颗粒的埃洛石纳米管得到最高的载药量,直径为50nm,长度为60nm的埃洛石纳米管可以沿着纤维方向排列,使力学性能两相异性,纤维膜具有很好的屏蔽性能和生物相容性,载药的纤维膜能够更长久的持续释放药物,延缓药物释放时间,释放的药物能够有效的抑制细菌的繁殖。
具体实施方式
为使本发明实现的技术手段、创作特征、达成目的与功效易于明白了解,下面结合具体实施方式,进一步阐述本发明。
在本发明的描述中,需要说明的是,术语“上”、“下”、“内”、“外”“前端”、“后端”、“两端”、“一端”、“另一端”等指示的方位或位置关系仅是为了便于描述本发明和简化描述,而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作,因此不能理解为对本发明的限制。此外,术语“第一”、“第二”仅用于描述目的,而不能理解为指示或暗示相对重要性。
在本发明的描述中,需要说明的是,除非另有明确的规定和限定,术语“安装”、“设置有”、“连接”等,应做广义理解,例如“连接”,可以是固定连接,也可以是可拆卸连接,或一体地连接;可以是机械连接,也可以是电连接;可以是直接相连,也可以通过中间媒介间接相连,可以是两个元件内部的连通。对于本领域的普通技术人员而言,可以具体情况理解上述术语在本发明中的具体含义。
本实施例提供一种含碘手术膜,包括第一纤维丝和第二纤维丝组成的纤维膜;以及覆盖在纤维膜上表面的与纤维膜同尺寸的壳聚糖-明胶复合膜;壳聚糖-明胶复合膜包括壳聚糖、明胶、乙醇和甘油,壳聚糖、明胶、乙醇和甘油的质量份分别为15-35份、20-40份、15-35份、6-12份;
第一纤维丝包括丝皮和第一丝芯,丝皮包括海藻酸钠、丁香油和胶原蛋白,海藻酸钠、丁香油和胶原蛋白的质量份为5-15份、1-3份和4-12份;
第一丝芯包括纤维素、壳聚糖乙酸和甲基咪唑氯盐离子液体,纤维素和甲基咪唑氯盐离子液体的质量比为1:19,且壳聚糖乙酸溶液的浓度为3wt%-7wt%;
第二纤维丝包括丝皮和含碘的第二丝芯,第二丝芯包括碘、醋酸、聚己内酯、明胶、三氟乙醇和埃洛石纳米管,碘、聚己内酯、明胶、埃洛石纳米管和醋酸的质量份分别为1-5份、8-40份、2-10份、0.6-3份和0.1-0.5份。
上述含碘手术膜,通过第一纤维丝和第二纤维丝来构成纤维膜,在纤维膜上覆盖壳聚糖-明胶复合膜,就获得含碘手术膜,其中第一丝芯包括纤维素和壳聚糖,纤维素和壳聚糖可以形成较强的氢键作用,二者结合紧密,使第一丝芯既具有较高的机械强度,同时又保持较高的透明性,壳聚糖的引入,能显著地提高手术膜的抗菌性能,并且丝皮对丝芯进行了适当包覆,降低了手术膜使用时的刺激性,同时具有丝芯缓释作用,使手术膜具有长效抗菌功能。
一种含碘手术膜的制备方法,包括以下步骤:
S1、制备含壳聚糖、明胶、乙醇和甘油的壳聚糖-明胶复合膜;
S1.1、将壳聚糖溶于1wt%的乙酸溶液中,在30℃下磁力搅拌使其溶解;
S1.2、同时配制适当浓度的明胶溶液,在55℃~60℃下水浴加热使其溶解;
S1.3、将壳聚糖溶液与明胶溶液按6∶4的体积比混合,并加入0.3wt%的甘油作为增塑剂,在30℃下磁力搅拌20min,然后超声脱气30min备用;
壳聚糖、明胶、乙醇和甘油的质量份分别为15-35份、20份、15-35份、6份。
S1.4、用量筒量取50ml膜液倒在底面光滑的培养皿中,置于60℃的干燥箱中干燥24h,干燥完毕将培养皿置于温度22℃的环境下过夜,然后揭膜并将膜样置于硅胶干燥器中平衡2h后备用;
S2、制备含海藻酸钠、丁香油和胶原蛋白的第一纺丝液;
S2.1、将海藻酸纳、丁香油和胶原蛋白分别置于40℃以下的蒸馏水中,搅拌混合均匀,获得第一纺丝液;
海藻酸纳、丁香油和胶原蛋白的质量份为5份、1份和4份。
S3、制备含纤维素和壳聚糖的第二纺丝液;
S3.1、称取2.5g纤维素加入到47.5g甲基咪唑氯盐离子液体中,80℃机械搅拌下至完全溶解,制备浓度为5wt%的纤维素溶液,然后将其倒在玻璃板上流延成型,以水做凝固剂制备出再生纤维素膜,随后将湿态再生纤维素膜分别放入浓度3wt%-7wt%的壳聚糖乙酸溶液中浸泡2h,即可获得第二纺丝液;
S4、制备含碘的第三纺丝液;
S4.1、将碘单质进行预研磨,获得D90≤6.0μm的碘颗粒;
S4.2、取一定量的研磨完毕的碘颗粒加入到甲醇中,搅拌使其溶解以得到其饱和溶液A;
S4.3、取一定量埃洛石纳米管与溶液A混合,超声分散得到埃洛石纳米管的悬浮液B;
S4.4、将悬浮液B抽真空直至液体表面不再有气泡出现,重复抽真空步骤3次,得到最高的药物载药量;
S4.5、离心后取出上清液,用甲醇清洗沉淀除去未吸进纳米管内的药物,即可得到载有碘颗粒的埃洛石纳米管;
S4.6、分别称取一定量的聚己内酯颗粒和明胶粉末,分别溶于三氟乙醇溶液中,磁力搅拌24h,得到均一的聚己内酯溶液和明胶溶液;
S4.7、将聚己内酯与明胶溶液以体积比80:20的比例混合后,加入微量的醋酸,搅拌6h后得到透明均一的聚合物溶液,聚己内酯、明胶和醋酸反应生成的聚合物占聚合物溶液的质量百分比为6wt%,在聚合物溶液中加入相对于聚合物质量20%的埃洛石纳米管,进而得到第三纺丝液;
碘、聚己内酯、明胶、埃洛石纳米管和醋酸的质量份分别为1-5份、8-40份、2-10份、0.6-3份和0.1-0.5份。
S5、将第一纺丝液作为纺织丝皮的外层注射液,第二纺丝液作为纺织第一纤维丝的内层注射液,第三纺丝液作为纺织第二纤维丝的内层注射液,使第一纤维丝和第二纤维丝形成纤维膜;
S6、在纤维膜上覆盖壳聚糖-明胶复合膜,获得含碘手术膜;
S6.1、将纤维膜在70-130℃环境下固化2min后,将壳聚糖-明胶复合膜覆盖在纤维膜上,用辊压机在施加130-170N的力下进行辊压,辊压后纤维膜会转移到壳聚糖-明胶复合膜上,然后获得含碘手术膜;
上述含碘手术膜的制备方法,由于在纤维膜上覆盖壳聚糖-明胶复合膜,减少了碘单质与皮肤直接接触,通过将悬浮液B抽真空直至液体表面不再有气泡出现,重复抽真空步骤3次,随后离心取出上清液,用甲醇清洗沉淀除去未吸进纳米管内的药物,即可得到载有碘颗粒的埃洛石纳米管得到最高的载药量,直径为50nm,长度为60nm的埃洛石纳米管可以沿着纤维方向排列,使力学性能两相异性,纤维膜具有很好的屏蔽性能和生物相容性,载药的纤维膜能够更长久的持续释放药物,延缓药物释放时间,释放的药物能够有效的抑制细菌的繁殖。
S7、在含碘手术膜的上下表面分别覆盖离型纸,然后进行紫外辐射灭菌,获得成品;
下面通过几个实例进行详细说明:
实例1
取质量份为15、20、15和6份的壳聚糖、明胶、乙醇和甘油,将壳聚糖溶于1wt%的乙酸溶液中,在30℃下磁力搅拌使其溶解;同时配制明胶溶液,在55℃~60℃下水浴加热使其溶解,再将壳聚糖溶液与明胶溶液按6∶4的体积比混合,并加入6份的甘油作为增塑剂,在30℃下磁力搅拌20min,然后超声脱气30min,用量筒量取50ml膜液倒在底面光滑的培养皿中,置于60℃的干燥箱中干燥24h,干燥完毕将培养皿置于温度22℃的环境下过夜,然后揭膜并将膜样置于硅胶干燥器中平衡2h后,获得壳聚糖-明胶复合膜。
取质量份分别为5份、1份、4份的海藻酸钠、丁香油和胶原蛋白,将海藻酸纳、丁香油和胶原蛋白分别置于40℃以下的蒸馏水中,搅拌混合均匀,获得第一纺丝液。
称取2.5g纤维素加入到47.5g甲基咪唑氯盐离子液体中,80℃机械搅拌下至完全溶解,制备浓度为5wt%的纤维素溶液,然后将其倒在玻璃板上流延成型,以水做凝固剂制备出再生纤维素膜,随后将湿态再生纤维素膜分别放入浓度3wt%的壳聚糖乙酸溶液中浸泡2h,即可获得第二纺丝液。
取质量份为1份、8份、2份、0.6份和0.1份的碘、聚己内酯、明胶、埃洛石纳米管和醋酸,先将1份碘单质进行预研磨,获得D90≤6.0μm的碘颗粒;随后将研磨完毕的碘颗粒加入到甲醇中,搅拌使其溶解以得到其饱和溶液A;随后将0.6份的埃洛石纳米管与溶液A混合,超声分散得到埃洛石纳米管的悬浮液B,将悬浮液B抽真空直至液体表面不再有气泡出现,重复抽真空步骤3次,得到最高的药物载药量;再将悬浮液B离心后取出上清液,用甲醇清洗沉淀除去未吸进纳米管内的药物,即可得到载有碘颗粒的埃洛石纳米管;将8份聚己内酯颗粒和2份明胶粉末,分别溶于三氟乙醇溶液中,磁力搅拌24h,得到均一的聚己内酯溶液和明胶溶液;随后将聚己内酯与明胶溶液以体积比80:20的比例混合后,加入0.1份的醋酸,搅拌6h后得到透明均一的聚合物溶液,聚己内酯、明胶和醋酸反应生成的聚合物占聚合物溶液的质量百分比为6wt%,在聚合物溶液中加入0.6份的埃洛石纳米管,进而得到第三纺丝液。
将第一纺丝液作为纺织第一丝皮和第二丝皮的外层注射液,第二纺丝液作为纺织第一纤维丝的内层注射液,第三纺丝液作为纺织第二纤维丝的内层注射液,使第一纤维丝和第二纤维丝形成纤维膜;随后将纤维膜在100℃环境下固化2min后,将壳聚糖-明胶复合膜覆盖在纤维膜上,用辊压机在施加130N的力下进行辊压,辊压后纤维膜会转移到壳聚糖-明胶复合膜上,然后获得含碘手术膜,最后在含碘手术膜的上下表面分别覆盖离型纸,然后进行紫外辐射灭菌,获得成品。
实例2
取质量份为25、30、25和9份的壳聚糖、明胶、乙醇和甘油,将壳聚糖溶于1wt%的乙酸溶液中,在30℃下磁力搅拌使其溶解;同时配制明胶溶液,在55℃~60℃下水浴加热使其溶解,再将壳聚糖溶液与明胶溶液按6∶4的体积比混合,并加入9份的甘油作为增塑剂,在30℃下磁力搅拌20min,然后超声脱气30min,用量筒量取50ml膜液倒在底面光滑的培养皿中,置于60℃的干燥箱中干燥24h,干燥完毕将培养皿置于温度22℃的环境下过夜,然后揭膜并将膜样置于硅胶干燥器中平衡2h后,获得壳聚糖-明胶复合膜。
取质量份分别为10份、2份、8份的海藻酸钠、丁香油和胶原蛋白,将海藻酸纳、丁香油和胶原蛋白分别置于40℃以下的蒸馏水中,搅拌混合均匀,获得第一纺丝液。
称取2.5g纤维素加入到47.5g甲基咪唑氯盐离子液体中,80℃机械搅拌下至完全溶解,制备浓度为5wt%的纤维素溶液,然后将其倒在玻璃板上流延成型,以水做凝固剂制备出再生纤维素膜,随后将湿态再生纤维素膜分别放入浓度5wt%的壳聚糖乙酸溶液中浸泡2h,即可获得第二纺丝液。
取质量份为3份、24份、6份、1.8份和0.3份的碘、聚己内酯、明胶、埃洛石纳米管和醋酸,先将3份碘单质进行预研磨,获得D90≤6.0μm的碘颗粒;随后将研磨完毕的碘颗粒加入到甲醇中,搅拌使其溶解以得到其饱和溶液A;随后将1.8份的埃洛石纳米管与溶液A混合,超声分散得到埃洛石纳米管的悬浮液B,将悬浮液B抽真空直至液体表面不再有气泡出现,重复抽真空步骤3次,得到最高的药物载药量;再将悬浮液B离心后取出上清液,用甲醇清洗沉淀除去未吸进纳米管内的药物,即可得到载有碘颗粒的埃洛石纳米管;将24份聚己内酯颗粒和6份明胶粉末,分别溶于三氟乙醇溶液中,磁力搅拌24h,得到均一的聚己内酯溶液和明胶溶液;随后将聚己内酯与明胶溶液以体积比80:20的比例混合后,加入0.3份的醋酸,搅拌6h后得到透明均一的聚合物溶液,聚己内酯、明胶和醋酸反应生成的聚合物占聚合物溶液的质量百分比为6wt%,在聚合物溶液中加入1.8份的埃洛石纳米管,进而得到第三纺丝液。
将第一纺丝液作为纺织第一丝皮和第二丝皮的外层注射液,第二纺丝液作为纺织第一纤维丝的内层注射液,第三纺丝液作为纺织第二纤维丝的内层注射液,使第一纤维丝和第二纤维丝形成纤维膜;随后将纤维膜在100℃环境下固化2min后,将壳聚糖-明胶复合膜覆盖在纤维膜上,用辊压机在施加150N的力下进行辊压,辊压后纤维膜会转移到壳聚糖-明胶复合膜上,然后获得含碘手术膜,最后在含碘手术膜的上下表面分别覆盖离型纸,然后进行紫外辐射灭菌,获得成品。
实例3
取质量份为35、40、35和12份的壳聚糖、明胶、乙醇和甘油,将壳聚糖溶于1wt%的乙酸溶液中,在30℃下磁力搅拌使其溶解;同时配制明胶溶液,在55℃~60℃下水浴加热使其溶解,再将壳聚糖溶液与明胶溶液按6∶4的体积比混合,并加入12份的甘油作为增塑剂,在30℃下磁力搅拌20min,然后超声脱气30min,用量筒量取50ml膜液倒在底面光滑的培养皿中,置于60℃的干燥箱中干燥24h,干燥完毕将培养皿置于温度22℃的环境下过夜,然后揭膜并将膜样置于硅胶干燥器中平衡2h后,获得壳聚糖-明胶复合膜。
取质量份分别为15份、3份、12份的海藻酸钠、丁香油和胶原蛋白,将海藻酸纳、丁香油和胶原蛋白分别置于40℃以下的蒸馏水中,搅拌混合均匀,获得第一纺丝液。
称取2.5g纤维素加入到47.5g甲基咪唑氯盐离子液体中,80℃机械搅拌下至完全溶解,制备浓度为5wt%的纤维素溶液,然后将其倒在玻璃板上流延成型,以水做凝固剂制备出再生纤维素膜,随后将湿态再生纤维素膜分别放入浓度7wt%的壳聚糖乙酸溶液中浸泡2h,即可获得第二纺丝液。
取质量份为5份、40份、10份、3份和0.5份的碘、聚己内酯、明胶、埃洛石纳米管和醋酸,先将5份碘单质进行预研磨,获得D90≤6.0μm的碘颗粒;随后将研磨完毕的碘颗粒加入到甲醇中,搅拌使其溶解以得到其饱和溶液A;随后将3份的埃洛石纳米管与溶液A混合,超声分散得到埃洛石纳米管的悬浮液B,将悬浮液B抽真空直至液体表面不再有气泡出现,重复抽真空步骤3次,得到最高的药物载药量;再将悬浮液B离心后取出上清液,用甲醇清洗沉淀除去未吸进纳米管内的药物,即可得到载有碘颗粒的埃洛石纳米管;将40份聚己内酯颗粒和10份明胶粉末,分别溶于三氟乙醇溶液中,磁力搅拌24h,得到均一的聚己内酯溶液和明胶溶液;随后将聚己内酯与明胶溶液以体积比80:20的比例混合后,加入0.5份的醋酸,搅拌6h后得到透明均一的聚合物溶液,聚己内酯、明胶和醋酸反应生成的聚合物占聚合物溶液的质量百分比为6wt%,在聚合物溶液中加入3份的埃洛石纳米管,进而得到第三纺丝液。
将第一纺丝液作为纺织第一丝皮和第二丝皮的外层注射液,第二纺丝液作为纺织第一纤维丝的内层注射液,第三纺丝液作为纺织第二纤维丝的内层注射液,使第一纤维丝和第二纤维丝形成纤维膜;随后将纤维膜在100℃环境下固化2min后,将壳聚糖-明胶复合膜覆盖在纤维膜上,用辊压机在施加170N的力下进行辊压,辊压后纤维膜会转移到壳聚糖-明胶复合膜上,然后获得含碘手术膜,最后在含碘手术膜的上下表面分别覆盖离型纸,然后进行紫外辐射灭菌,获得成品。
对比例
取质量份为45、50、45和15份的壳聚糖、明胶、乙醇和甘油,将壳聚糖溶于1wt%的乙酸溶液中,在30℃下磁力搅拌使其溶解;同时配制明胶溶液,在55℃~60℃下水浴加热使其溶解,再将壳聚糖溶液与明胶溶液按6∶4的体积比混合,并加入15份的甘油作为增塑剂,在30℃下磁力搅拌20min,然后超声脱气30min,用量筒量取50ml膜液倒在底面光滑的培养皿中,置于60℃的干燥箱中干燥24h,干燥完毕将培养皿置于温度22℃的环境下过夜,然后揭膜并将膜样置于硅胶干燥器中平衡2h后,获得壳聚糖-明胶复合膜。
取质量份分别为20份、4份、16份的海藻酸钠、丁香油和胶原蛋白,将海藻酸纳、丁香油和胶原蛋白分别置于40℃以下的蒸馏水中,搅拌混合均匀,获得第一纺丝液。
称取2.5g纤维素加入到47.5g甲基咪唑氯盐离子液体中,80℃机械搅拌下至完全溶解,制备浓度为5wt%的纤维素溶液,然后将其倒在玻璃板上流延成型,以水做凝固剂制备出再生纤维素膜,随后将湿态再生纤维素膜分别放入浓度9wt%的壳聚糖乙酸溶液中浸泡2h,即可获得第二纺丝液。
取质量份为7份、56份、14份、4.2份和0.7份的碘、聚己内酯、明胶、埃洛石纳米管和醋酸,先将7份碘单质进行预研磨,获得D90≤6.0μm的碘颗粒;随后将研磨完毕的碘颗粒加入到甲醇中,搅拌使其溶解以得到其饱和溶液A;随后将4.2份的埃洛石纳米管与溶液A混合,超声分散得到埃洛石纳米管的悬浮液B,将悬浮液B抽真空直至液体表面不再有气泡出现,重复抽真空步骤3次,得到最高的药物载药量;再将悬浮液B离心后取出上清液,用甲醇清洗沉淀除去未吸进纳米管内的药物,即可得到载有碘颗粒的埃洛石纳米管;将56份聚己内酯颗粒和14份明胶粉末,分别溶于三氟乙醇溶液中,磁力搅拌24h,得到均一的聚己内酯溶液和明胶溶液;随后将聚己内酯与明胶溶液以体积比80:20的比例混合后,加入0.7份的醋酸,搅拌6h后得到透明均一的聚合物溶液,聚己内酯、明胶和醋酸反应生成的聚合物占聚合物溶液的质量百分比为6wt%,在聚合物溶液中加入4.2份的埃洛石纳米管,进而得到第三纺丝液。
将第一纺丝液作为纺织第一丝皮和第二丝皮的外层注射液,第二纺丝液作为纺织第一纤维丝的内层注射液,第三纺丝液作为纺织第二纤维丝的内层注射液,使第一纤维丝和第二纤维丝形成纤维膜;随后将纤维膜在100℃环境下固化2min后,将壳聚糖-明胶复合膜覆盖在纤维膜上,用辊压机在施加170N的力下进行辊压,辊压后纤维膜会转移到壳聚糖-明胶复合膜上,然后获得含碘手术膜,最后在含碘手术膜的上下表面分别覆盖离型纸,然后进行紫外辐射灭菌,获得成品。
手术膜性能测试试验如下:(1)力学性能分析:用裁切刀将样品裁剪成100mm×15mm的长方形样条,然后夹于CMT6103型电子万能试验机上,将夹具间初始距离和标距都设置为50mm,拉伸速度设为50mm/min。每组分别测量5个平行试验,记录每次试验后样品的拉伸强度和断裂伸长率,分别取平均值记录最终结果。
(2)阻隔性能分析:由于膜主要由纳米纤维素构成,所以膜的水蒸气透过率很高,因此仅考虑测量膜的氧气透过率,且湿度条件不能过高,设置湿度条件RH=35%,输入膜的参数直径和厚度,采用MOCON氧气透过率测试仪测定每种薄膜的氧气透过率,在结果稳定后从后三个结果中求平均,然后每种膜测三次求平均。
(3)光学透射率分析:用紫外分光光度计测定,以透光率的大小表示膜的透明度。将待测复合膜切成1cm×3cm矩形并固定于比色皿内侧,在600nm下测定吸光度A值,每种膜测三次求平均值,最后按A=-lgT公式换算出透光率T值。
(4)抗菌性能分析:将25gLB液体培养基粉末和15g琼脂LB固体培养基粉末分别加到蒸馏水中定容至1L,然后分装于锥形瓶中,置于高温灭菌锅中,高温灭菌30min,冷却到45℃后将大肠杆菌和金黄色葡萄球菌放入LB液体培养液中进行活化培养,于37℃摇床中培养24h,另外将固体培养基置于45℃恒温箱内备用;向各培养皿内注入15mL~20mL的固体培养基,然后取活化好的菌悬液等量加入培养皿中,待其冷却凝固;将制成的膜用打孔器打成直径为1.5cm的圆膜放在培养基表面,然后放置在37℃的生化培养箱中培养14h;最后用十字交叉法观察透明抑菌圈直径并用游标卡尺测量,每组各做3个平行样最后取平均。
判定标准:抑菌圈大小与滤纸直径的差>9mm(极度敏感);6-9mm(高度敏感);4-5mm(中度敏感);1-3mm(低度敏感);<1mm(不敏感),抑菌圈直径与抗菌活性成正比。
实例1 | 实例2 | 实例3 | 对比例 | |
力学性能,N | 124.5 | 118.6 | 112.5 | 88.7 |
阻隔性能,% | 1.01% | 0.95% | 0.98% | 3.3% |
光学透射率,% | 83.70% | 85.80% | 83.50% | 65.80% |
抗菌性能,mm | 20.14 | 19.97 | 21.92 | 16.35 |
从表中可以看出,本实施例的实例1-3的力学性能的平均值为118.5,远大于对比例的88.7,力学性能强意味着用该制备方法制造出来的手术膜的强度要大于对比例的强度。
三个实例的阻隔性能均为1%左右,说明手术膜的膜的氧气透过率非常低,在使用时,能有效阻隔外界环境的病菌透过手术膜对伤患处产生损害,而对比例的阻隔性能为3.3%,虽然阻隔性能也很优异,在使用该种手术膜时相对三个实例的手术膜来说,更容易让空气中的氧气携带病菌进入伤患处,使用的局限性较大。
三个实例的光学透射率性能均为84%左右,说明手术膜的透光率较高,手术膜下面的皮肤也可以被清楚观察,而对比例的阻隔性能为65.8%,在使用该种手术膜时容易使医务人员产生误导,不容易清晰的观察到手术膜下的情况。
三个实例的抗菌性能的直径为20mm左右,远大于9mm,说明手术膜的抗菌性能非常强,虽然对比例的直径为16.35,也大于9mm,但是相比较来说,还是三个实例的抗菌性能更强。
由此,本实施例的含碘手术膜能充分利用各组分的优势,显著地提高手术膜的力学性能、阻隔性能、光学透射率和抗菌性能,并且载药的纤维膜能够更长久的持续释放药物,延缓药物释放时间,释放的药物能够有效的抑制细菌的繁殖。
以上显示和描述了本发明的基本原理和主要特征和本发明的优点。本行业的技术人员应该了解,本发明不受上述实施例的限制,上述实施例和说明书中描述的只是说明本发明的原理,在不脱离本发明精神和范围的前提下,本发明还会有各种变化和改进,这些变化和改进都落入要求保护的本发明范围内。本发明要求保护范围由所附的权利要求书及其等效物界定。
Claims (9)
1.一种含碘手术膜,其特征在于:包括第一纤维丝和第二纤维丝组成的纤维膜;以及覆盖在纤维膜上表面的与纤维膜同尺寸的壳聚糖-明胶复合膜;所述壳聚糖-明胶复合膜包括壳聚糖、明胶、乙醇和甘油,所述壳聚糖、明胶、乙醇和甘油的质量份分别为15-35份、20-40份、15-35份、6-12份;
所述第一纤维丝包括丝皮和第一丝芯,所述丝皮包括海藻酸钠、丁香油和胶原蛋白,所述海藻酸钠、丁香油和胶原蛋白的质量份为5-15份、1-3份和4-12份;
所述第一丝芯包括纤维素、壳聚糖乙酸和甲基咪唑氯盐离子液体,所述纤维素和甲基咪唑氯盐离子液体的质量比为1:19,且所述壳聚糖乙酸溶液的浓度为3wt%-7wt%;
所述第二纤维丝包括丝皮和含碘的第二丝芯,所述第二丝芯包括碘、醋酸、聚己内酯、明胶、三氟乙醇和埃洛石纳米管,所述碘、聚己内酯、明胶、埃洛石纳米管和醋酸的质量份分别为1-5份、8-40份、2-10份、0.6-3份和0.1-0.5份。
2.根据权利要求1所述的一种含碘手术膜,其特征在于:所述埃洛石纳米管需要使用甲醇清洗,所述埃洛石纳米管的直径为50nm,长度为60nm。
3.根据权利要求1所述的一种含碘手术膜,其特征在于:所述碘单质被研磨成碘颗粒,加入到甲醇中,搅拌溶解得到其饱和溶液A。
4.一种含碘手术膜的制备方法,其特征在于:包括以下步骤:
制备含壳聚糖、明胶、乙醇和甘油的壳聚糖-明胶复合膜;
制备含海藻酸钠、丁香油和胶原蛋白的第一纺丝液;
制备含纤维素和壳聚糖的第二纺丝液;
制备含碘的第三纺丝液;
将第一纺丝液作为纺织丝皮的外层注射液,第二纺丝液作为纺织第一纤维丝的内层注射液,第三纺丝液作为纺织第二纤维丝的内层注射液,使第一纤维丝和第二纤维丝形成纤维膜;
在所述纤维膜上覆盖壳聚糖-明胶复合膜,获得含碘手术膜。
5.根据权利要求4所述的一种含碘手术膜的制备方法,其特征在于:制备所述壳聚糖-明胶复合膜的步骤包括:
将壳聚糖溶于1wt%的乙酸溶液中,在30℃下磁力搅拌使其溶解;
同时配制适当浓度的明胶溶液,在55℃~60℃下水浴加热使其溶解;
将壳聚糖溶液与明胶溶液按6∶4的体积比混合,并加入0.3wt%的甘油作为增塑剂,在30℃下磁力搅拌20min,然后超声脱气30min备用;
用量筒量取50ml膜液倒在底面光滑的培养皿中,置于60℃的干燥箱中干燥24h,干燥完毕将培养皿置于温度22℃的环境下过夜,然后揭膜并将膜样置于硅胶干燥器中平衡2h后备用。
6.根据权利要求4所述的一种含碘手术膜的制备方法,其特征在于:制备所述第一纺丝液的具体步骤如下:将海藻酸纳、丁香油和胶原蛋白分别置于40℃以下的蒸馏水中,搅拌直至混合均匀,获得第一纺丝液。
7.根据权利要求4所述的一种含碘手术膜的制备方法,其特征在于:制备所述第二纺丝液的具体步骤如下:称取2.5g纤维素加入到47.5g甲基咪唑氯盐离子液体中,在80℃的环境下,机械搅拌下至完全溶解,制备浓度为5wt%的纤维素溶液,然后将其倒在玻璃板上流延成型,以水做凝固剂制备出再生纤维素膜,随后将湿态再生纤维素膜分别放入浓度3wt%-7wt%的壳聚糖乙酸溶液中浸泡2h,即可获得第二纺丝液。
8.根据权利要求4所述的一种含碘手术膜的制备方法,其特征在于:制备所述第三纺丝液的具体步骤如下:
将碘单质进行预研磨,获得D90≤6.0μm的碘颗粒;
取一定量的研磨完毕的碘颗粒加入到甲醇中,搅拌使其溶解以得到其饱和溶液A;
取一定量埃洛石纳米管与溶液A混合,超声分散得到埃洛石纳米管的悬浮液B:
将悬浮液B抽真空直至液体表面不再有气泡出现,重复抽真空步骤3次,得到最高的药物载药量;
离心后取出上清液,用甲醇清洗沉淀除去未吸进纳米管内的药物,即可得到载有碘颗粒的埃洛石纳米管;
分别称取一定量的聚己内酯颗粒和明胶粉末,分别溶于三氟乙醇溶液中,磁力搅拌24h,得到均一的聚己内酯溶液和明胶溶液;
将聚己内酯与明胶溶液以体积比80:20的比例混合后,加入微量的醋酸,搅拌6h后得到透明均一的聚合物溶液,聚己内酯、明胶和醋酸反应生成的聚合物占聚合物溶液的质量百分比为6wt%,在聚合物溶液中分别加入相对于聚合物质量20%的埃洛石纳米管,进而得到第三纺丝液。
9.根据权利要求4所述的一种含碘手术膜的制备方法,其特征在于:所述在纤维膜上覆盖壳聚糖-明胶复合膜的具体步骤如下:将纤维膜在70-130℃环境下固化2min后,将壳聚糖-明胶复合膜覆盖在纤维膜上,用辊压机在施加130-170N的力下进行辊压,辊压后纤维膜会转移到壳聚糖-明胶复合膜上,然后获得含碘手术膜。
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