CN111956859B - 一种含中药成分的抗菌止血创可贴及其制备方法 - Google Patents
一种含中药成分的抗菌止血创可贴及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种含中药成分的抗菌止血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、壳聚糖止血层和可剥离层组成。黏性背衬由可降解的壳聚糖无纺布制成，药物层是将中药粉末通过粉末压制法制备而成的薄膜，主要包含三七、白芨和牡蛎壳粉末等成分。本发明所制备的创可贴具有良好的止血、消肿止痛、祛疤和抗菌效果。在促进伤口愈合的同时，也防止了愈合过程中伤口感染的出现。本发明所制备的创可贴制造技术简单、操作流出少、制作成本低，适用于大规模生产；同时，该创可贴采用的是新型生物材料，具有环保、无污染和可生物降解等优势。相关实验也表明该创可贴生物相容性好、对伤口无刺激性且、产品无毒副作用。本发明所制备的创可贴可应用于小创口、擦伤及切割伤等浅表性创面伤口的护理，具有推广应用的价值。
Description
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中药成分的抗菌止血创可贴。
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。早期，人们通过传统的干性敷料对伤口进行处理，即使用纱布或绷带对伤口进行覆盖，从而隔绝外界微生物，避免了伤口的进一步感染，然后通过患者本身的愈合修复能力，来使伤口愈合。创可贴作为一种常见的干性敷料而广泛应用于伤口处理，其主要由平面胶布、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。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。湿润性敷料不仅可以使细胞保持活力，使其释放生长因子，同时保持细胞与愈合组织之间的接触，调节或刺激它们的增殖。湿润性敷料可减少患者休息、走路和换药期间的疼痛。同时，湿润环境可以快速有地递送任何添加的抗菌剂，从而防止伤口被感染。现在认为产生和维持湿润环境的敷料为伤口愈合提供了最佳条件。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。 因而如何改进创可贴生产工艺，使其在保留原有优势的同时，让伤口处于一种湿润性的愈合环境将是未来的研究热点。
发明内容
本发明的目的在于提供一种含中药成分的抗菌止血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。
本发明提供的含中药成分的抗菌止血创可贴的制备方法，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三七、白芨和牡蛎壳粉末，精确到小数点后两位；
(2)将称量好的粉末混合均匀，然后通过粉末压制法挤压成模；
(3)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止血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；
(4)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中药成分的抗菌止血创可贴。
本发明所用黏性背衬是由医用级纯壳聚糖纤维水刺无纺布制成的并涂以低过敏的医用压敏胶；所用药物层包含三七、白芨和牡蛎壳粉末等成分，通过粉末压制法制备而成的薄膜；所用药液由以下质量百分含量的成分组成：三七30~40%、白芨30~40%和牡蛎壳粉末20~40%，三者都是传统中药材，所用壳聚糖止血层为水溶性壳聚糖纤维，遇水后可形成胶装物质，所用可剥离层为格拉辛纸、CCK纸或PET膜。
本发明与伤口直接接触的为中药层，其所含的三七和白芨都是中医中传统的止血药物，三七具有散瘀止血、消肿定痛的作用，白芨具有收敛止血、消肿生肌的作用，牡蛎壳粉含有动物体内铜、镁、钾、钼、磷、锰、铁、锌等多种必需的微量元素和多种氨基酸等营养成分，为伤口愈合提供了必要的营养物质。壳聚糖止血层为水溶性壳聚糖，相关文献都表明壳聚糖具有良好的抗菌性。该止血层可以瞬间吸收伤口渗出液或血液，溶解后成凝胶状，为伤口创造一个湿润的环境，从而促进伤口的愈合；其形成的凝胶将伤口与外界环境中的微生物隔绝，从而避免伤口感染的发生；其吸液溶解后具有一定的粘性，可吸附和凝结在伤口处，以达到快速止血的目的；其可以减小伤口疤痕，修复皮肤组织；其不会与伤口发生粘连，减少患者换药时的痛苦。所用黏性背衬是医用级壳聚糖无纺布，长期使用也不会造成伤口及其周围的皮肤发白和***，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。
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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中药成分的抗菌止血创可贴，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三七、白芨和牡蛎壳粉末，精确到小数点后两位；
(2)将称量好的粉末混合均匀，然后通过粉末压制法挤压成模；
(3)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止血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；
(4)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中药成分的抗菌止血创可贴。
实施例1
(1)在称量实验室通过分析天平准确称量40.00g三七、40.00g白芨和20.00g牡蛎壳粉末；
(2)将称量好的粉末混合均匀，然后通过粉末压制法挤压成0.15mm的药物薄膜；
(3)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止血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；
(4)通过辐照灭菌，灭菌完成即可获得相应的含中药成分的抗菌止血创可贴。
实施例2
(1)在称量实验室通过分析天平准确称量30.00g三七、30.00g白芨和40.00g牡蛎壳粉末；
(2)将称量好的粉末混合均匀，然后通过粉末压制法挤压成0.15mm的药物薄膜；
(3)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止血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；
(4)通过辐照灭菌，灭菌完成即可获得相应的含中药成分的抗菌止血创可贴。
实施例3
(1)在称量实验室通过分析天平准确称量35.00g三七、35.00g白芨和30.00g牡蛎壳粉末；
(2)将称量好的粉末混合均匀，然后通过粉末压制法挤压成0.15mm的药物薄膜；
(3)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止血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；
(4)通过环氧乙烷灭菌，灭菌完成即可获得相应的含中药成分的抗菌止血创可贴。
实施例4
(1)在称量实验室通过分析天平准确称量32.00g三七、32.00g白芨和36.00g牡蛎壳粉末；
(2)将称量好的粉末混合均匀，然后通过粉末压制法挤压成0.15mm的药物薄膜；
(3)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止血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；
(4)通过环氧乙烷灭菌，灭菌完成即可获得相应的含中药成分的抗菌止血创可贴。
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创可贴生物性质检测实验结果
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所含壳聚糖成分有关，同时，该创可贴含有的三七和白芨等中药粉末也促进了伤口的愈合。
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，每隔6h观察并记录伤口愈合情况，18h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，这可能源于壳聚糖的抗菌活性，三七和白芨的消炎、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 (3)
1.一种含中药成分的抗菌止血创可贴，其特征在于，该创可贴由黏性背衬、药物层、壳聚糖止血层和可剥离层组成，其顺序依次为黏性背衬、壳聚糖止血层、药物层和可剥离层，黏性背衬是由医用级纯壳聚糖纤维水刺无纺布制成的并涂以低过敏的医用压敏胶，药物层是采用粉末压制法制成的薄膜，与伤口直接接触，
所用药物层由以下质量百分含量的成分组成：三七30~40%、白芨30~40%和牡蛎壳粉末20~40%，三者都是传统中药材，壳聚糖止血层为水溶性壳聚糖纤维，遇水后可形成胶状物质。
2.根据权利要求1所述的含中药成分的抗菌止血创可贴，其特征在于，所用可剥离层为格拉辛纸、CCK纸或PET膜。
3.根据权利要求1所述的含中药成分的抗菌止血创可贴，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三七、白芨和牡蛎壳粉末，精确到小数点后两位；将称量好的粉末混合均匀，然后通过粉末压制法挤压成膜；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止血层按尺寸规格要求黏合，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中药成分的抗菌止血创可贴。
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