CN114521559A - 一种医用抗菌材料的制备方法及其医用抗菌材料和应用 - Google Patents
一种医用抗菌材料的制备方法及其医用抗菌材料和应用 Download PDFInfo
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Abstract
本发明具体涉及一种医用抗菌材料的制备方法及其医用抗菌材料和应用,按重量组分计,包括以下具体步骤:在室温下,将醋酸溶液加入到反应器中,加入壳聚糖,搅拌使其完全溶解,得到透明溶液;在遮光条件下,向透明溶液中加入硝酸银溶液,搅拌得到混合溶液;将水合肼溶液滴加到混合溶液中,待滴加完毕后,继续搅拌;待反应完成后,加入碳酸氢钠溶液调节pH至碱性,析出沉淀,过滤,得沉淀物;将沉淀物用纯水冲洗2‑4次,加入葡萄籽提取物后在均质机内均质,然后进行真空干燥,得到抗菌材料。本发明得到的抗菌材料抗菌效果好,不会变色,抗菌时间长,可用于导尿管、一次性使用血液透析管路等医疗器械产品中,抗菌效果好。
Description
技术领域
本发明属于医疗器械技术领域,具体涉及一种医用抗菌材料的制备方法及其医用抗菌材料和应用。
背景技术
抗菌材料是指自身具有杀灭有害细菌或抑制有害细菌生长繁殖功能的一种新型功能材料,主要是通过其中的抗菌剂成分与有害细菌的细胞发生作用,从而达到杀灭细菌的效果。抗菌剂主要有天然、有机、无机三大类。天然抗菌剂主要来自于天然植物的提取物,如壳聚糖、日柏醇、山梨酸等,该类抗菌剂安全性高、适用范围广,但其耐热性差、易受生产条件的限制,不易规模化生产;有机抗菌剂主要成分为有机酸类、酚类、季铵盐类、吡唑类物质,具有杀菌速度快、杀菌性能好的优点,但是存在耐热性差、寿命短、易分解等缺点,使其应用受到限制;无机抗菌剂是利用银、铜、锌等金属的抗菌能力,通过物理吸附离子交换等方法,将银、铜、锌等金属(或其离子)固定在氟石、硅胶等多孔材料的表面制成抗菌剂,然后将其加入到相应的制品中即获得具有抗菌能力的材料,具有较高的耐热性、持续性、抗菌广谱性等优点,但是水银、镉、铅等金属虽然也具有抗菌能力,但对人体有害,铜、镍、钴等离子带有颜色,影响产品的美观,银遇光或长期保存极易氧化变色,使得其使用时容易聚集导致有效成分流失而降低抗菌能力。由于每种抗菌剂都各有优缺点,使得抗菌效果均并不是很好,因此,开发具有高效抑菌的医用材料显得尤为重要。
发明内容
针对现有技术的不足,本发明的目的是提供一种医用抗菌材料的制备方法及其医用抗菌材料和应用,该医用抗菌材料通过将无机抗菌剂和天然抗菌进行配合,性能互补,协同增效,同时克服其缺陷,得到的抗菌材料抗菌、抗炎效果好,遇光不会变色,抗菌时间长,可用于导尿管、一次性使用血液透析管路等医疗器械产品中,制成溶液后喷洒在产品内表面形成均匀抗菌涂层,可提升产品抗菌性。
为实现上述目的,本发明提供一种医用抗菌材料的制备方法,按重量组分计,包括以下具体步骤:
S1.在室温下,将50-70份醋酸溶液加入到反应器中,启动搅拌装置,然后加入0.5-2份壳聚糖,搅拌20-40min,使其完全溶解,得到略带黄色的透明溶液;具体地搅拌速度可以为300-500rpm/min;
S2.在遮光条件下,向S1获得透明溶液中加入15-25份的硝酸银溶液,搅拌20-30min;具体地搅拌速度可以为300-500rpm/min;
S3.将3-5份的水合肼溶液滴加到S2的混合溶液中,边滴加边快速搅拌,待滴加完毕后,继续搅拌反应30-50min;具体地搅拌速度可以为
1000-1500rpm/min;
S4.待S3混合溶液反应完成后,加入碳酸氢钠溶液并搅拌,调节溶液的pH至碱性,析出沉淀后,过滤,得沉淀物;具体的搅拌速度可以为300-500rpm/min;
S5.将S4所得沉淀物用纯水冲洗2-4次,加入2-4份葡萄籽提取物在均质机内均质10-20min,然后将混合物进行真空干燥,得到抗菌材料。具体地,均质压力为15-25MPa;真空干燥温度为45-55℃。
壳聚糖具有良好的抗菌性能,对大肠杆菌、铜绿假单胞菌、金黄色葡萄球菌、等有良好的抑制作用,同时具有良好的生物相容性,能应用于医疗器械产品。葡萄籽提取物是一种新型高效天然抗氧化物质,能有效清除人体多余的自由基,具有增强免疫力的作用,同时又是一种天然的阳光遮盖物,能阻挡紫外线等辐射,还具有抗炎作用,用于损害组织,可以帮助治愈受损组织缓解疼痛。本发明先将壳聚糖溶解在酸中,形成溶胀体,氨基暴露,容易与银离子络合,并作为银的载体,获得具有抗菌性能的复合材料,加入的水合肼作为还原剂,可以有效防止银离子被氧化,最后在复合材料表面包裹一层具有极强抗氧化、吸收紫外线特性的葡萄籽提取物,可有效防止银被光氧化、变色,保持长效的强抗菌作用,同时用于植入体表面时,不仅能解决感染问题,还可提高抗炎作用,提高植入成功率。
进一步的,上述技术方案中,按重量组分计,包括以下具体步骤:
S1.在室温下,将60份醋酸溶液加入到反应器中,启动搅拌装置,然后加入1份壳聚糖,搅拌30min,使其完全溶解,得到略带黄色的透明溶液;
S2.在遮光条件下,向S1获得透明溶液中加入20份的硝酸银溶液,搅拌30min;
S3.将4份的水合肼溶液滴加到S2的混合溶液中,边滴加边快速搅拌,待滴加完毕后,继续搅拌反应40min;
S4.待S3混合溶液反应完成后,加入碳酸氢钠溶液并搅拌,调节溶液的pH至碱性,析出沉淀后,过滤,得沉淀物;
S5.将S4所得沉淀物用纯水冲洗3次,加入3份葡萄籽提取物在均质机内均质15min,然后将混合物进行真空干燥,得到抗菌材料。
进一步的,上述技术方案中,S1中,所述醋酸溶液的浓度为2-3%的醋酸溶液。
进一步的,上述技术方案中S2中,所述硝酸银溶液的浓度为0.08-0.12mol/L。
进一步的,上述技术方案中,S3中,所述水合肼溶液的浓度为0.8-1.5mol/L。
进一步的,上述技术方案中S4中,所述pH调节至8-9。
本发明还提供一种由上述制备方法制得的医用抗菌材料。
本发明还提供一种由上述医用抗菌材料在导尿管、一次性使用血液透析管路等医疗器械产品中的应用。本发明将具有抗菌作用的抗菌材料应用于导尿管、一次性使用血液透析管路等医疗器械产品,可显著降低产品使用的感染风险,在预防术后感染和炎症等方面也起到了重要作用。
进一步的,在使用前,将所述医用抗菌材料用无水乙醇分散制成含量为1-5%的溶液后喷洒于医疗器械产品表面。抗菌材料在医疗器械产品表层形成一层抗菌涂层,可有效抑制细菌等微生物活性,解决感染问题,提高抗炎作用。
本发明具有的有益效果是:
本发明医用抗菌材料通过将无机抗菌剂、天然抗菌剂以及助剂进行配合制备成复合抗菌材料,不仅抗菌性能得到提高,在助剂的作用下,克服其缺陷,得到的抗菌材料抗菌、抗炎效果好,耐温、抗光敏性能好,不会变色,抗菌时间长;
本发明制备方法简单,常温下就可完成,制作成本低,制备的抗菌材料可应用于导尿管、一次性使用血液透析管路等医疗器械产品中,制成溶液后喷洒在产品内表面可形成均匀抗菌涂层,可显著提升产品的抗菌、抗炎能力。
具体实施方式
下述实施例中的实验方法,如无特别说明,均为常规方法。下述实施例涉及的原料若无特别说明,均为普通市售品,皆可通过市场购买获得。
下面结合实施例对本发明作进一步详细描述:
实施例1
一种医用抗菌材料的制备方法,按重量组分计,包括以下具体步骤:
S1.在室温下,将50份3%的醋酸溶液加入到反应器中,启动搅拌装置,然后加入0.5份壳聚糖,以300rpm/min的速度搅拌40min,使其完全溶解,得到略带黄色的透明溶液;
S2.在遮光条件下,向S1获得透明溶液中加入25份浓度为0.08mol/L的硝酸银溶液,以300rpm/min的速度搅拌30min;
S3.将3份浓度为1.5mol/L的水合肼溶液滴加到S2的混合溶液中,边滴加边以1000rpm/min的速度快速搅拌,待滴加完毕后,继续搅拌反应50min;
S4.待S3混合溶液反应完成后,加入碳酸氢钠溶液并以300rpm/min的速度搅拌,调节溶液的pH至8,析出沉淀后,过滤,得沉淀物;
S5.将S4所得沉淀物用纯水冲洗2次,加入2份葡萄籽提取物在压力为15MP的均质机内均质20min,然后将混合物在温度为45℃条件下进行真空干燥,得到抗菌材料。
实施例2
一种医用抗菌材料的制备方法,按重量组分计,包括以下具体步骤:
S1.在室温下,将60份2%的醋酸溶液加入到反应器中,启动搅拌装置,然后加入1份壳聚糖,以400rpm/min的速度搅拌30min,使其完全溶解,得到略带黄色的透明溶液;
S2.在遮光条件下,向S1获得透明溶液中加入20份浓度为0.1mol/L的硝酸银溶液,以400rpm/min的速度搅拌25min;
S3.将4份浓度为1mol/L的水合肼溶液滴加到S2的混合溶液中,边滴加边以1200rpm/min的速度快速搅拌,待滴加完毕后,继续搅拌反应40min;
S4.待S3混合溶液反应完成后,加入碳酸氢钠溶液并以400rpm/min的速度搅拌,调节溶液的pH至8.5,析出沉淀后,过滤,得沉淀物;
S5.将S4所得沉淀物用纯水冲洗3次,加入3份葡萄籽提取物在压力为20MP的均质机内均质15min,然后将混合物在温度为50℃条件下进行真空干燥,得到抗菌材料。
实施例3
一种医用抗菌材料的制备方法,按重量组分计,包括以下具体步骤:
S1.在室温下,将70份2%的醋酸溶液加入到反应器中,启动搅拌装置,然后加入2份壳聚糖,以500rpm/min的速度搅拌20min,使其完全溶解,得到略带黄色的透明溶液;
S2.在遮光条件下,向S1获得透明溶液中加入25份浓度为0.08mol/L的硝酸银溶液,以500rpm/min的速度搅拌20min;
S3.将5份浓度为0.8mol/L的水合肼溶液滴加到S2的混合溶液中,边滴加边以1500rpm/min的速度快速搅拌,待滴加完毕后,继续搅拌反应30min;
S4.待S3混合溶液反应完成后,加入碳酸氢钠溶液并以500rpm/min的速度搅拌,调节溶液的pH至9,析出沉淀后,过滤,得沉淀物;
S5.将S4所得沉淀物用纯水冲洗4次,加入4份葡萄籽提取物在压力为25MP的均质机内均质10min,然后将混合物在温度为55℃条件下进行真空干燥,得到抗菌材料。
对比例1
一种医用抗菌材料的制备方法,按重量组分计,包括以下具体步骤:
S1.在室温下,将60份2%的醋酸溶液加入到反应器中,启动搅拌装置,然后加入1份壳聚糖,以400rpm/min的速度搅拌30min,使其完全溶解,得到略带黄色的透明溶液;
S2.在遮光条件下,向S1获得透明溶液中加入20份浓度为0.1mol/L的硝酸银溶液,以400rpm/min的速度搅拌25min;
S3.向S2混合溶液中加入碳酸氢钠溶液并以400rpm/min的速度搅拌,调节溶液的pH至8.5,析出沉淀后,过滤,得沉淀物;
S4.将S3所得沉淀物用纯水冲洗3次,然后在温度为50℃条件下进行真空干燥,得到抗菌材料。
对比例2
一种医用抗菌材料的制备方法,按重量组分计,包括以下具体步骤:
S1.在室温下,将60份2%的醋酸溶液加入到反应器中,启动搅拌装置,然后加入1份壳聚糖,以400rpm/min的速度搅拌30min,使其完全溶解,得到略带黄色的透明溶液;
S2.在遮光条件下,向S1获得透明溶液中加入20份浓度为0.1mol/L的硝酸银溶液,以400rpm/min的速度搅拌25min;
S3.将4份浓度为1mol/L的水合肼溶液滴加到S2的混合溶液中,边滴加边以1200rpm/min的速度快速搅拌,待滴加完毕后,继续搅拌反应40min;
S4.待S3混合溶液反应完成后,加入碳酸氢钠溶液并以400rpm/min的速度搅拌,调节溶液的pH至8.5,析出沉淀后,过滤,得沉淀物;
S5.将S4所得沉淀物用纯水冲洗3次,然后在温度为50℃条件下进行真空干燥,得到抗菌材料。
将实施例1-3、对比例1-2制备的抗菌材料分别用无水乙醇制成抗菌材料为3%的溶液以及分别将壳聚糖、硝酸银制成与实施例2中等量的溶液后进行抗菌试验(参照照GB15979-2002方法进行检验),结果如表1所示。
表1抗菌结果(抑菌率%)
从表1的结果可以看出,本发明实施例1-3制备的抗菌材料对大肠杆菌、金黄色葡萄球菌、铜绿假单胞菌的抗菌率都在99.9%以上;而将壳聚糖和硝酸银单独直接用于抗菌,其抗菌率只有69%-73.3%之间,而本申请实施例中将壳聚糖和硝酸银并配合本申请制备方法,抗菌率显著提高,说明两者具有协同增效的作用;对比例1中直接将壳聚糖和硝酸银混合,不使用水合肼和葡萄籽提取的情况下,虽然较单独使用抗菌效果更好,但是比实施例2的抗菌率显著降低,说明本发明制备方法能有效防止抗菌有效成分被降解;对比例2中未添加葡萄籽提取物,其抗菌率也较实施例2显著降低,说明葡萄籽提取物能有效防止抗菌有效成分被降解。
将实施例2和对比例2所制备的抗菌材料分别用无水乙醇制成抗菌材料为3%的溶液后喷洒于医疗器械表面,观察其在灯光下照射的颜色变化,结果如表2所示。
表2颜色变化
从表2的结果可以看出,对比例2中不含葡萄籽提取物的抗菌材料,暴露在光下后,容易被氧化,光敏性差;而实施例2抗菌材料中添加有葡萄籽提取物助剂,其抗氧化、抗光敏作用显著提高,在光照情况下不变色。
综上所述,本发明制备方法制备的抗菌材料具有优良的抗菌、抗炎效果,同时抗氧化、抗光敏性能好,遇光不会变色,有效成本被破坏,抗菌时间长。
最后需要强调的是,以上所述仅为本发明的优选实施例,并不用于限制本发明,对于本领域的技术人员来说,本发明可以有各种变化和更改,凡在本发明的精神和原则之内,所做的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。
Claims (9)
1.一种医用抗菌材料的制备方法,其特征在于,按重量组分计,包括以下具体步骤:
S1.在室温下,将50-70份醋酸溶液加入到反应器中,启动搅拌装置,然后加入0.5-2份壳聚糖,搅拌20-40min,使其完全溶解,得到略带黄色的透明溶液;
S2.在遮光条件下,向S1获得透明溶液中加入15-25份的硝酸银溶液,搅拌20-30min;
S3.将3-5份的水合肼溶液滴加到S2的混合溶液中,边滴加边快速搅拌,待滴加完毕后,继续搅拌反应30-50min;
S4.待S3混合溶液反应完成后,加入碳酸氢钠溶液并搅拌,调节溶液的pH至碱性,析出沉淀后,过滤,得沉淀物;
S5.将S4所得沉淀物用纯水冲洗2-4次,加入2-4份葡萄籽提取物在均质机内均质10-20min,然后将混合物进行真空干燥,得到抗菌材料。
2.根据权利要求1所述的一种医用抗菌材料的制备方法,其特征在于,按重量组分计,包括以下具体步骤:
S1.将60份醋酸溶液加入到反应器中,启动搅拌装置,然后加入1份壳聚糖,搅拌30min,使其完全溶解,得到略带黄色的透明溶液;
S2.在遮光条件下,向S1获得透明溶液中加入20份的硝酸银溶液,搅拌30min;
S3.在室温下,将4份的水合肼溶液滴加到S2的混合溶液中,边滴加边快速搅拌,待滴加完毕后,继续搅拌反应40min;
S4.待S3混合溶液反应完成后,加入碳酸氢钠溶液并搅拌,调节溶液的pH至碱性,析出沉淀后,过滤,得沉淀物;
S5.将S4所得沉淀物用纯水冲洗3次,加入3份葡萄籽提取物在均质机内均质15min,然后将混合物进行真空干燥,得到抗菌材料。
3.根据权利要求1或2所述的一种医用抗菌材料的制备方法,其特征在于,S1中,所述醋酸溶液的浓度为2-3%的醋酸溶液。
4.根据权利要求1或2所述的一种医用抗菌材料的制备方法,其特征在于,S2中,所述硝酸银溶液的浓度为0.08-0.12mol/L。
5.根据权利要求1或2所述的一种医用抗菌材料的制备方法,其特征在于,S3中,所述水合肼溶液的浓度为0.8-1.5mol/L。
6.根据权利要求1或2所述的一种医用抗菌材料的制备方法,其特征在于,S4中,所述pH调节至8-9。
7.一种由权利要求1-6任一项所述的制备方法制得的医用抗菌材料。
8.一种由权利要求7所述医用抗菌材料在导尿管、一次性使用血液透析管路等医疗器械产品中的应用。
9.根据权利要求8所述的应用,其特征在于,在使用前,将所述医用抗菌材料用无水乙醇分散制成含量为1-5%的溶液后喷洒于医疗器械产品表面。
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