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CN112076339B - 一种含氧化锌纳米颗粒的抗菌创可贴及其制备方法 - Google Patents

一种含氧化锌纳米颗粒的抗菌创可贴及其制备方法 Download PDF

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CN112076339B
CN112076339B CN202010970157.2A CN202010970157A CN112076339B CN 112076339 B CN112076339 B CN 112076339B CN 202010970157 A CN202010970157 A CN 202010970157A CN 112076339 B CN112076339 B CN 112076339B
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zinc oxide
vitamin
layer
chitosan
growth factor
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张海军
鞠豪
尹玉霞
侯文博
刘爱华
张明广
卢天恒
曹明昆
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Shandong Branden Medical Devices Co Ltd
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Abstract

本发明公开了一种含氧化锌纳米颗粒的抗菌创可贴及其制备方法，属于医疗用品技术领域。本发明所制备的创可贴由黏性背衬、药物层、壳聚糖无纺布层和可剥离层组成。壳聚糖无纺布层上含有通过浸渍法连接上的纳米级氧化锌，药物层上附着有含有中药成分的药剂，该药剂包含小蓟提取物、壳聚糖季铵盐、生长因子、氨基酸和复合维生素等成分。该发明解决了现有创可贴不能促进伤口愈合的问题，实现了促进伤口快速愈合和防止伤口感染的技术效果。本发明所制备的创可贴制造技术简单、生物相容性好、成本低、对伤口无刺激性且可以吸收伤口的渗出液、产品安全且无毒副作用，可应用于小创口、擦伤及切割伤等浅表性创面伤口的护理。

Description

一种含氧化锌纳米颗粒的抗菌创可贴及其制备方法
技术领域
本发明属于医疗用品技术领域，具体涉及到了一种含氧化锌纳米颗粒的抗菌创可贴及其制备方法。
背景技术
创伤是正常皮肤在外界致伤因子（外力、热、外科手术、电流、化学物质和低温等）和机体内在因素（局部供血不足）共同作用下所发生的损害。伤口的出现一般会伴随着皮肤完整性的破坏和部分正常组织的丢失，从而造成皮肤正常功能受损。伤口修复是一个多细胞和多细胞因子共同参与的复杂过程，创口敷料在治疗和修复伤口的过程中起着重要的作用。在使用敷料对伤口进行处理时，敷料可以隔绝外界微生物，避免伤口的进一步感染，然后利用自身的愈合修复能力，来促进伤口的愈合。湿润性愈合理论提出后，人们越来越多的倾向使用液体敷料或水凝胶敷料等符合湿润性愈合理论的新型敷料，但是大部分新型敷料目前仍然处于试验阶段，商品化产品较少。创可贴因其快速的止血和护创功能而受到不同人群的欢迎，在未来的一段时间内，创可贴仍然将是人们外出、居家和工作必备的药械。
创可贴主要由平面胶布、吸水层和可剥离层组成，具有止血和护创的作用。它的止血作用主要靠平面胶布的粘粘作用形成压力来止血并通过吸水层的吸水作用来吸收渗出物以保持伤口相对干燥，促进伤口愈合。传统创可贴的透气性不佳，在使用过程中很容易造成葡萄球菌、破伤风杆菌等厌氧细菌的繁殖，从而造成了创面的难以愈合、化脓、结痂，影响了细胞的再生和创面的愈合。
发明内容
本发明的目的在于提供一种含氧化锌纳米颗粒的抗菌创可贴及其制备方法。该方法制备的创可贴可以用于皮肤创伤较为表浅，伤口不宽、出血不多且不用缝合的伤口，以用来止血、止痛和消淤。
本发明提供的含氧化锌纳米颗粒的抗菌创可贴的制备方法，其特征在于，包括以下制备步骤：
(1)在称量实验室通过分析天平准确称量所需的小蓟提取物、壳聚糖季铵盐、生长因子、氨基酸和复合维生素，精确到小数点后两位；
(2)通过量筒和移液管准确量取制备所需的超纯水；
(3)将超纯水加入烧杯中，在50~150r/min的速度搅拌下，向其中依次加入小蓟提取物、壳聚糖季铵盐、生长因子、氨基酸和复合维生素，搅拌溶解并使溶液混合均匀；
(4)将药物层无纺布放入浸药槽中，浸泡1~10min，然后放入40~50°C的烘箱烘干，重复上述步骤两次；
(5)将壳聚糖无纺布在25~35°C在含有纳米级氧化锌的整理液中浸渍10~30min。然后在40~80°C下烘干，重复上述步骤两次；
(6)将粘性背衬按照尺寸要求分切，与分切好的药物层和壳聚糖无纺布层按尺寸规格要求粘合，药物层和壳聚糖无纺布层位于粘性背衬的中间，然后将可剥离层附于粘性背衬胶面上，冷封彩纸与白纸分别从附着好可剥离层的粘性背衬上下密封，使每一片创可贴都单独密封好；
(7)通过辐照灭菌或者环氧乙烷灭菌；灭菌完成即可获得相应的含氧化锌纳米颗粒的抗菌创可贴。
本发明所用黏性背衬采用医用PU膜、医用弹力布或医用无纺中的一种，涂以低过敏的医用压敏胶；所用药物层包含小蓟提取物、壳聚糖季铵盐、生长因子、氨基酸和复合维生素等成分，通过药液浸泡无纺布制成；所用药液由以下质量百分含量的成分组成：小蓟提取物4~10%、壳聚糖季铵盐0~5%、生长因子0.01~0.05%、氨基酸0~2%、复合维生素0~2%和超纯水80.95%~95.99%；所用小蓟提取物是通过申请号为202010890248.5专利所述提取方法所制备的；所用壳聚糖季铵盐是壳聚糖经过化学改性修饰而制备的白色或类白色粉末状固体，分子量在1000~100万之间；所用生长因子为表皮生长因子（EGF）、角质细胞生长因子（KGF）、成纤维细胞生长因子（FGF）、血小板源生长因子（PDGF）、血管内皮生长因子（VEGF）、转化生长因子（TGFα和TGFβ）中的一种或多种；所用氨基酸为甘氨酸、丙氨酸、缬氨酸、亮氨酸、异亮氨酸、苯丙氨酸、脯氨酸、色氨酸、丝氨酸、酪氨酸、半胱氨酸、蛋氨酸、天冬酰胺、谷氨酰胺、苏氨酸、天冬氨酸、谷氨酸、赖氨酸、精氨酸和组氨酸中的一种或多种的组合；所用维生素复合物为维生素A、维生素B1、维生素B2、维生素B5、维生素B6、维生素C、维生素E和肌醇中的一种或多种维生素与维生素K组成的维生素复合物；所用超纯水为符合中国药典2015版注射用水项下规定的水，即蒸馏水或去离子水经过二次蒸馏所得的水；所用壳聚糖无纺布为医用级纯壳聚糖纤维水刺无纺布，该无纺布通过浸渍法连接着纳米级的氧化锌；所用可剥离层为格拉辛纸、CCK纸或PET膜。
本发明以壳聚糖无纺布作为与伤口的接触层，透气性好，长期使用也不会造成伤口及其周围的皮肤发白和变软，同时壳聚糖无纺布层含有的纳米级氧化锌具有良好的抗菌性，防止伤口出现细菌继发性感染，同时壳聚糖无纺布是生物材料可以大大减少过敏现象的发生，药物层的中药组分也会加快了伤口愈合。
附图说明
图1是创可贴生产流程图；图2是创可贴产品结构图。
具体实施方式
本发明揭示了一种含氧化锌纳米颗粒的抗菌创可贴，其制备方法的操作步骤如下：
(1)在称量实验室通过分析天平准确称量所需的小蓟提取物、壳聚糖季铵盐、生长因子、氨基酸和复合维生素，精确到小数点后两位；
(2)通过量筒和移液管准确量取制备所需的超纯水；
(3)将超纯水加入烧杯中，在50~150r/min的速度搅拌下，向其中依次加入小蓟提取物、壳聚糖季铵盐、生长因子、氨基酸和复合维生素，搅拌溶解并使溶液混合均匀；
(4)将药物层无纺布放入浸药槽中，浸泡1~10min，然后放入40~50°C的烘箱烘干，重复上述步骤两次；
(5)将壳聚糖无纺布在25~35°C在含有纳米级氧化锌的整理液中浸渍10~30min。然后在40~80°C下烘干，重复上述步骤两次；
(6)将粘性背衬按照尺寸要求分切，与分切好的药物层和壳聚糖无纺布层按尺寸规格要求粘合，药物层和壳聚糖无纺布层位于粘性背衬的中间，然后将可剥离层附于粘性背衬胶面上，冷封彩纸与白纸分别从附着好可剥离层的粘性背衬上下密封，使每一片创可贴都单独密封好；
(7)通过辐照灭菌或者环氧乙烷灭菌；灭菌完成即可获得相应的含氧化锌纳米颗粒的抗菌创可贴。
实施例1
(1)在称量实验室通过分析天平准确称量所需的5.00g小蓟提取物、2.00g壳聚糖季铵盐、0.02g生长因子、1.00g氨基酸和1.00g复合维生素，精确到小数点后两位；
(2)通过量筒和移液管准确量取90.98ml超纯水；
(3)将超纯水加入烧杯中，在120r/min的速度搅拌下，向其中依次加入小蓟提取物、壳聚糖季铵盐、生长因子、氨基酸和复合维生素，搅拌溶解并使溶液混合均匀；
(4)将药物层无纺布放入浸药槽中，浸泡10min，然后放入45°C的烘箱烘干，重复上述步骤两次；
(5)将壳聚糖无纺布在30°C在含有纳米级氧化锌的整理液中浸渍10min。然后在40°C下烘干，重复上述步骤两次；
(6)将粘性背衬按照尺寸要求分切，与分切好的药物层和壳聚糖无纺布层按尺寸规格要求粘合，药物层和壳聚糖无纺布层位于粘性背衬的中间，然后将可剥离层附于粘性背衬胶面上，冷封彩纸与白纸分别从附着好可剥离层的粘性背衬上下密封，使每一片创可贴都单独密封好；
(7)通过辐照灭菌；灭菌完成即可获得相应的含氧化锌纳米颗粒的抗菌创可贴。
实施例2
(1)在称量实验室通过分析天平准确称量所需的6.00g小蓟提取物、3.00g壳聚糖季铵盐、0.02g生长因子、1.00g氨基酸和1.00g复合维生素，精确到小数点后两位；
(2)通过量筒和移液管准确量取88.98ml超纯水；
(3)将超纯水加入烧杯中，在120r/min的速度搅拌下，向其中依次加入小蓟提取物、壳聚糖季铵盐、生长因子、氨基酸和复合维生素，搅拌溶解并使溶液混合均匀；
(4)将药物层无纺布放入浸药槽中，浸泡10min，然后放入45°C的烘箱烘干，重复上述步骤两次；
(5)将壳聚糖无纺布在30°C在含有纳米级氧化锌的整理液中浸渍10min。然后在40°C下烘干，重复上述步骤两次；
(6)将粘性背衬按照尺寸要求分切，与分切好的药物层和壳聚糖无纺布层按尺寸规格要求粘合，药物层和壳聚糖无纺布层位于粘性背衬的中间，然后将可剥离层附于粘性背衬胶面上，冷封彩纸与白纸分别从附着好可剥离层的粘性背衬上下密封，使每一片创可贴都单独密封好；
(7)通过辐照灭菌；灭菌完成即可获得相应的含氧化锌纳米颗粒的抗菌创可贴。
实施例3
(1)在称量实验室通过分析天平准确称量所需的6.00g小蓟提取物、3.00g壳聚糖季铵盐、0.02g生长因子、1.50g氨基酸和1.50g复合维生素，精确到小数点后两位；
(2)通过量筒和移液管准确量取87.98ml超纯水；
(3)将超纯水加入烧杯中，在120r/min的速度搅拌下，向其中依次加入小蓟提取物、壳聚糖季铵盐、生长因子、氨基酸和复合维生素，搅拌溶解并使溶液混合均匀；
(4)将药物层无纺布放入浸药槽中，浸泡10min，然后放入45°C的烘箱烘干，重复上述步骤两次；
(5)将壳聚糖无纺布在30°C在含有纳米级氧化锌的整理液中浸渍10min。然后在40°C下烘干，重复上述步骤两次；
(6)将粘性背衬按照尺寸要求分切，与分切好的药物层和壳聚糖无纺布层按尺寸规格要求粘合，药物层和壳聚糖无纺布层位于粘性背衬的中间，然后将可剥离层附于粘性背衬胶面上，冷封彩纸与白纸分别从附着好可剥离层的粘性背衬上下密封，使每一片创可贴都单独密封好；
(7)通过环氧乙烷灭菌；灭菌完成即可获得相应的含氧化锌纳米颗粒的抗菌创可贴。
实施例4
(1)在称量实验室通过分析天平准确称量所需的8.00g小蓟提取物、5.00g壳聚糖季铵盐、0.05g生长因子、2.00g氨基酸和2.00g复合维生素，精确到小数点后两位；
(2)通过量筒和移液管准确量取82.95ml超纯水；
(3)将超纯水加入烧杯中，在120r/min的速度搅拌下，向其中依次加入小蓟提取物、壳聚糖季铵盐、生长因子、氨基酸和复合维生素，搅拌溶解并使溶液混合均匀；
(4)将药物层无纺布放入浸药槽中，浸泡10min，然后放入45°C的烘箱烘干，重复上述步骤两次；
(5)将壳聚糖无纺布在30°C在含有纳米级氧化锌的整理液中浸渍10min。然后在40°C下烘干，重复上述步骤两次；
(6)将粘性背衬按照尺寸要求分切，与分切好的药物层和壳聚糖无纺布层按尺寸规格要求粘合，药物层和壳聚糖无纺布层位于粘性背衬的中间，然后将可剥离层附于粘性背衬胶面上，冷封彩纸与白纸分别从附着好可剥离层的粘性背衬上下密封，使每一片创可贴都单独密封好；
(7)通过环氧乙烷灭菌；灭菌完成即可获得相应的含氧化锌纳米颗粒的抗菌创可贴。
创可贴性质检测
我们对实施例1至实施例4所制备的创可贴分别进行细胞毒性实验（依据GB/T142332-2005第八章的检测方法）、刺激性和致敏性实验（依据GB/T16886.10-2017的检测方法）、皮内反应（依据GB/T16886.10-2017的检测方法）、全身急性毒性实验（依据GB/T16886.11-2011的检测方法）、重金属含量检测（依据中国药典2015版 0821重金属检查法的检测方法）。根据姚建磊等人(姚建磊，气相色谱-质谱法测定乙二醇二缩水甘油醚中环氧氯丙烷的残留量，理化检验-化学分册，2018年第54卷)报道的方法来检测实施例3和实施例4中环氧氯丙烷的残留量检测结果如表1所示。
表1含氧化锌纳米颗粒的抗菌创可贴生物性质检测实验结果
Figure 345593DEST_PATH_IMAGE002
本发明实施例1至实施例4的相关实验结果还表明该抗菌创可贴无细胞毒性、生物相容性好、无刺激性和过敏性、对人体无害，符合医疗卫生用品的检测标准。该创可贴的杀菌作用主要与创可贴含有的纳米级氧化锌、壳聚糖和壳聚糖季铵盐有关，该创可贴含有的生长因子和中药提取物促进了伤口的愈合。
创可贴愈合实验
愈合实验应该使用健康的5~6周龄的C57BL/6雄性小鼠，应使小鼠先适应饲养环境并按照ISO10993-2的规定饲养。对于实施例1至4的创可贴进行愈合实验，具体实验步骤如下：取25只C57BL/6雄性小鼠，随机分成五组，编号A、B、C、D和E，适应性喂养3到5天后，进行实验。将小鼠分别装入尾静脉注射固定器中，在其尾部切出深浅、大小差不多的伤口，A到D组分别使用实施例1到实施例4的创可贴，E组不做任何处理使其自然愈合作为对照组，正常饲养，每隔24h换取新的创可贴，观察并记录伤口愈合情况，24h之后，经过创可贴处理过的小鼠伤口分别开始愈合，而空白对照小鼠在72h之后才开始愈合；96h之后，经过创可贴处理的小鼠创口基本完全愈合且在愈合过程中未出现感染现象，未经处理的伤口需要168h才能愈合，表明本发明的创可贴可以有效促进伤口愈合和防止伤口感染，这可能源于纳米级氧化锌的抗菌活性和小蓟提取物的消炎、止血活性。
以上实施例仅用以说明本发明的技术方案， 并非对本发明的技术范围作任何限制，对于本领域的普通技术人员来说，依然可以对前述实施例所记载的技术方案进行细微修改，或者对其中部分技术特征进行等同替换而这些修改或替换，并不使相应技术方案的本质脱离本发明所要求保护的技术方案的精神和范围。

Claims (10)

1.一种含氧化锌纳米颗粒的抗菌创可贴，其特征在于，该创可贴由黏性背衬、和创口直接接触的壳聚糖无纺布层，位于两者之间的药物层和附于黏性背衬胶面上的可剥离层组成，药物层包含小蓟提取物、壳聚糖季铵盐、生长因子、氨基酸和复合维生素成分，通过药液浸泡无纺布制成，所用药液由以下质量百分含量的成分组成：小蓟提取物4~10%、壳聚糖季铵盐0~5%、生长因子0.01~0.05%、氨基酸0~2%、复合维生素0~ 2%和超纯水80.95%~ 95.99%，壳聚糖季铵盐、氨基酸和复合维生素的最低含量不为0，壳聚糖无纺布层为医用级纯壳聚糖纤维水刺无纺布，该无纺布通过浸渍法连接着纳米级的氧化锌。
2.根据权利要求1所述的含氧化锌纳米颗粒的抗菌创可贴，其特征在于，所用黏性背衬根据所制成创可贴的特性而采用医用PU膜、医用弹力布和医用无纺布中的一种，涂以低过敏的医用压敏胶。
3.根据权利要求1所述的含氧化锌纳米颗粒的抗菌创可贴，其特征在于，所用小蓟提取物是通过申请号为202010890248 .5专利提取方法所制备的。
4.根据权利要求1所述的含氧化锌纳米颗粒的抗菌创可贴，其特征在于，所用壳聚糖季铵盐是壳聚糖经过化学改性修饰而制备的白色或类白色粉末状固体，分子量在1000~100万之间。
5.根据权利要求1所述的含氧化锌纳米颗粒的抗菌创可贴，其特征在于，所用生长因子为表皮生长因子、角质细胞生长因子、成纤维细胞生长因子、血小板源生长因子、血管内皮生长因子、转化生长因子中的一种或多种。
6.根据权利要求1所述的含氧化锌纳米颗粒的抗菌创可贴，其特征在于，所用氨基酸为甘氨酸、丙氨酸、缬氨酸、亮氨酸、异亮氨酸、苯丙氨酸、脯氨酸、色氨酸、丝氨酸、酪氨酸、半胱氨酸、蛋氨酸、天冬酰胺、谷氨酰胺、苏氨酸、天冬氨酸、谷氨酸、赖氨酸、精氨酸和组氨酸中的一种或多种的组合。
7.根据权利要求1所述的含氧化锌纳米颗粒的抗菌创可贴，其特征在于，所用复合维生素为维生素A、维生素B1、维生素B2、维生素B5、维生素B6、维生素C、维生素E中的一种或多种维生素与维生素K组成的复合维生素。
8.根据权利要求1所述的含氧化锌纳米颗粒的抗菌创可贴，其特征在于，所用超纯水为符合中国药典2015版注射用水项下规定的水，即蒸馏水或去离子水经过二次蒸馏所得的水。
9.根据权利要求1所述的含氧化锌纳米颗粒的抗菌创可贴，其特征在于，所用可剥离层为格拉辛纸、CCK纸或PET膜。
10.根据权利要求1所述的含氧化锌纳米颗粒的抗菌创可贴，其特征在于，其制备方法的操作步骤如下：在称量实验室通过分析天平准确称量所需的小蓟提取物、壳聚糖季铵盐、生长因子、氨基酸和复合维生素，精确到小数点后两位；通过量筒和移液管准确量取制备所需的超纯水；将超纯水加入烧杯中，在50~150r/min的速度搅拌下，向其中依次加入小蓟提取物、壳聚糖季铵盐、生长因子、氨基酸和复合维生素，搅拌溶解并使溶液混合均匀；将药物层无纺布放入浸药槽中，浸泡1~10min，然后放入40~50℃的烘箱烘干，重复上述步骤两次；将壳聚糖无纺布在25~35℃在含有纳米级氧化锌的整理液中浸渍10~30min，然后在40~80℃下烘干，重复上述步骤两次；将黏性背衬按照尺寸要求分切，与分切好的药物层和壳聚糖无纺布层按尺寸规格要求粘合，药物层和壳聚糖无纺布层位于黏性背衬的中间，然后将可剥离层附于黏性背衬胶面上，冷封彩纸与白纸分别从附着好可剥离层的黏性背衬上下密封，使每一片创可贴都单独密封好；通过辐照灭菌或者环氧乙烷灭菌；灭菌完成即可获得相应的含氧化锌纳米颗粒的抗菌创可贴。
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