CN112206281A - 一种抗感染修复创面的药物组合物及其制备方法与应用 - Google Patents
一种抗感染修复创面的药物组合物及其制备方法与应用 Download PDFInfo
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Abstract
本申请公开了生物医用技术领域的一种抗感染修复创面的药物组合物,按重量份数包括以下原料:壳聚糖盐酸盐30‑40份、杉木80‑120份、白芨30‑36份、冰片2‑8份和甘油450‑550份。上述药物组合物应用为喷膜制剂的制备方法,包括以下步骤:步骤一、按比例称取上述原料,杉木和白芨炮制后研磨成细粉;步骤二、将PVA1788与壳聚糖盐酸盐在40℃水浴条件下加入到蒸馏水中,磁力搅拌至完全溶解;步骤三、加入杉木粉末、白芨粉末和冰片,再加入甘油,于磁力搅拌中继续搅拌至溶解完全,放置室温待泡沫消除;步骤四、再加入无水乙醇,搅拌均匀,放置5min后装瓶;步骤五、分装紫外灭菌。本发明的药物组合物具有抗渗出、防粘连、止血、抗感染和促进伤口愈合等作用。
Description
技术领域
本发明属于生物医用技术领域,特别涉及一种抗感染修复创面的药物组合物及其制备方法与应用。
背景技术
皮肤创伤是一种临床常见损伤,皮肤创伤后常伴随出血、疼痛等症状,严重者易引起感染等一系列并发症,不仅不利于伤口快速愈合,同时可能影响患者学习、工作等社会活动,降低其生活质量。目前,临床上用于治疗皮肤床上的药物及剂型种类繁多,中医药在治疗创面愈合、加速创面修复具有一定的优势,中药方剂的内服与外用可从多个靶点、多环节综合性调控创面愈合及修复过程。
近年来,创伤修复的研究炙手可热,成为外科研究领域中的热门课题之一,主要原因如下:(1)随着经济科技的发展,交通意外、工伤创伤伤员数量迅速增加;(2)因截肢、糖尿病、辐射等所致的慢性伤口增多;(3)伴随着人们生活水平的提高,人们迫切地希望能更好地解决瘢痕增生等问题,追求完美愈合;(4)近二十年来分子生物学理论迅速发展,创伤修复领域相关的分子生物学技术也逐渐拓展开来,使各种研究更加深入;(5)基因工程的发展对创伤修复研究起了促进作用。(6)由于抗生素的广泛应用,MRSA类创面耐药菌感染已成为阻碍创面愈合最主要原因之一,皮肤药理学的出现在一定程度上推进了创伤修复与组织再生的基础研究以及临床应用进展,而中医药为我国传统医学,其在创伤的治疗上有着独特理解和丰富经验。中医对创面外用药的原则主要有:①行气活血、推陈致新;②燥湿收脓、脓肤肌生;③酸涩收口、生肌收口;④复方中药外用。本专利将传统医学与现代药理学结合,致力于探究其对促进创伤修复过程的积极作用。
喷膜剂是制剂领域中一种结合膜剂、喷膜制剂优点的新型透皮制剂。其主要成分壳聚糖,是甲壳素的脱乙酰产物,是迄今所发现的唯一天然碱性多糖,具有良好的生物相容性和可降解性。喷膜剂以溶液状态储存,雾状喷出后可快速形成通气性良好的可溶性生物膜,可直接喷于患处,避免外涂时,产生的创口疼痛;溶剂挥发后形成的隔离薄膜对创面具有物理和生化双重抗菌消炎作用,同时所含药物被逐渐释放并可发挥持续治疗效果。喷膜剂具有止血、减少创面渗出、促进创伤组织再生、修复、愈合等作用,在某些皮肤病、口腔疾病及各种外伤康复等治疗中发挥着显著作用,是促进各类创面愈合的理想材料之一。
发明内容
本发明意的目的是提供一种抗渗出、防粘连、止血、抗感染和促进伤口愈合的药物组合物及其制备方法。
本方案提供如下方案:一种抗感染修复创面的药物组合物,按重量份数包括以下原料:壳聚糖盐酸盐30-40份、杉木80-120份、白芨30-36份、冰片2-8份和甘油450-550份。
优选的,上述抗感染修复创面的药物组合物按重量份数包括以下原料:壳聚糖盐酸盐33-37份、杉木90-110份、白芨32-34份、冰片3-7份和甘油485-525份。
优选的,上述抗感染修复创面的药物组合物按重量份数包括以下原料:壳聚糖盐酸盐33份、杉木110份、白芨34份、冰片3份和甘油485份。
优选的,上述抗感染修复创面的药物组合物按重量份数包括以下原料:壳聚糖盐酸盐35份、杉木100份、白芨33份、冰片5份和甘油504份。
本发明还提供以下方案,根据上述抗感染修复创面的药物组合物的应用:将药物组合物制备为喷膜制剂、膏剂或贴剂。
优选的,将药物组合物制备为喷膜制剂。
本发明还提供以下方案,药物组合物应用为喷膜制剂的制备方法,包括以下步骤:
步骤一、按比例称取上述原料,杉木和白芨炮制后研磨成细粉,取PVA1788、无水乙醇和蒸馏水备用;
步骤二、将PVA1788与壳聚糖盐酸盐在40℃水浴条件下加入到蒸馏水中,磁力搅拌至完全溶解;
步骤三、加入杉木粉末、白芨粉末和冰片,再加入甘油,于磁力搅拌中继续搅拌至溶解完全,放置室温待泡沫消除;
步骤四、再加入无水乙醇,搅拌均匀,放置5min后装瓶;
步骤五、分装紫外灭菌。
优选的,所述杉木的炮制为烧灰存性。
本方案的有益效果为:
杉木,我国南方重要的造林树种,具有生长迅速、加工简单、材料易得等特点,对治疗风湿毒疮、跌打肿痛、创伤出血、烧烫伤等症状具有一定功效。白芨属止血药下属分类的收敛止血药,具收敛止血、消肿生肌之效,同时有美白祛斑、营养肌肤、延缓皮肤衰老的功效,并且对皮肤无刺激性、无毒副作用。冰片,气清香,味辛、凉,具有一定开窍醒神,对清热、止痛、消炎作用有促透效果。
本发明利用杉木作为复方君药,应用白芨作为复方臣药,以壳聚糖盐酸盐和PVA1788作为喷膜剂的主要成膜材料,以天然透皮促进剂冰片促进渗透,制备促进皮肤创面修复的杉木复方喷膜剂。该制剂喷洒于创面后可形成透气保湿的隔离膜,不仅可保护创面并形成湿性环境,同时还具有抗渗出、防粘连、止血、抗感染和促进伤口愈合等作用。
另外,喷膜制剂的用药方式可避免肝脏首关消除效应和药物在胃肠道的降解,药物的吸收不受食物、胃液等胃肠道因素影响,减少用药的个体效应;一次给药可长时间使药物以恒定速度进入体内,延长给药间隔,减少给药次数;喷膜制剂给药可避免口服等给药方式引起的药物浓度峰谷现象,维持恒定有效血药浓度,降低了毒副反应;使用方便,操作简单可随时中断给药,减少耐药性的产生;使用药物均为中药木材类,可降低耐药菌株产生的风险。
本专利所制杉木复方创伤修复喷膜制剂应用于项背部皮肤受损的SD大鼠,进行在体实验,结果显示其可显著抑菌效果,可促进皮肤快速收敛愈合。
附图说明
图1为本发明实施例中大鼠创面修复效果图。
具体实施方式
下面通过具体实施方式进一步详细说明:
实施例1:一种抗感染修复创面的药物组合物:按重量份数包括以下原料:壳聚糖盐酸盐30份、杉木80份、白芨30份、冰片2份和甘油450份。
实施例2:一种抗感染修复创面的药物组合物:按重量份数包括以下原料:壳聚糖盐酸盐33份、杉木110份、白芨34份、冰片3份和甘油485份。
实施例3:一种抗感染修复创面的药物组合物:按重量份数包括以下原料:壳聚糖盐酸盐35份、杉木100份、白芨33份、冰片5份和甘油504份。
实施例4:根据实施例3的药物组合物制成喷膜制剂,制备方法如下:
步骤一、按成品量100ml称取原料:壳聚糖盐酸盐0.35g,杉木1.0g,白芨0.33g,冰片0.05g,PVA1788 1.75g,4.0ml甘油(甘油密度为1.26g/cm3,重量为5.04g);杉木经过烧灰存性后研极细末;白芨研极细末干燥。
步骤二、将PVA1788与壳聚糖盐酸盐在40℃水浴条件下加入到蒸馏水中,磁力搅拌至完全溶解;
步骤三、加入杉木粉末、白芨粉末和冰片,再加入甘油,于磁力搅拌中继续搅拌至溶解完全,放置室温待泡沫消除;
步骤四、再加入无水乙醇,搅拌均匀,放置5min后装瓶;
步骤五、紫外灭菌。
动物创伤模型制备:18只SD大鼠随机分为空白对照组、阳性对照组、实验组共3组,每组雌雄各半。用脱毛膏对大鼠背部脱毛,脱毛面积约5cm×5cm,背部脱毛区域皮肤消毒后,采用异氟烷吸入式全身麻醉,利用手术剪于大鼠上背部制备直径约2.5cm的圆形全层皮肤切除创面,深达肌层。
药物治疗:大鼠完成造模后置于大饲养笼中单笼饲养。①空白对照组:创面仅使用生理盐水喷涂;②阳性对照组(待测量):创面使用舒涣医用创面保护膜。③实验组(待测量):创面使用杉木复方创面修复喷膜制剂。各组每24小时给药1次直至愈合(给药时给予清创以及揭痂处理),实验结果如图1所示。
数据测量:①观察大鼠在造模时和给药后,创面渗出物、感染、结痂情况以及创面愈合面积,对创口大小进行描边扫描,并拍照记录;②组织切片染色检测炎症细胞数量;③采集创面分泌物,检测巨噬细胞数量和炎性因子含量。
通过实验结果可以明显得知本发明的药物组合物制作的喷膜制剂具有显著抑菌及快速愈合的效果。
Claims (8)
1.一种抗感染修复创面的药物组合物,其特征在于:按重量份数包括以下原料:壳聚糖盐酸盐30-40份、杉木80-120份、白芨30-36份、冰片2-8份和甘油450-550份。
2.根据权利要求1所述的一种抗感染修复创面的药物组合物,其特征在于:按重量份数包括以下原料:壳聚糖盐酸盐33-37份、杉木90-110份、白芨32-34份、冰片3-7份和甘油485-525份。
3.根据权利要求2所述的一种抗感染修复创面的药物组合物,其特征在于:按重量份数包括以下原料:壳聚糖盐酸盐33份、杉木110份、白芨34份、冰片3份和甘油485份。
4.根据权利要求2所述的一种抗感染修复创面的药物组合物,其特征在于:按重量份数包括以下原料:壳聚糖盐酸盐35份、杉木100份、白芨33份、冰片5份和甘油504份。
5.根据权利要求1-4任一所述的抗感染修复创面的药物组合物的应用,其特征在于:所述药物组合物制备为喷膜制剂、膏剂或贴剂。
6.根据权利要求5所述的抗感染修复创面的药物组合物的应用,其特征在于:所述药物组合物制备为喷膜制剂。
7.根据权利要求6所述的抗感染修复创面的药物组合物应用为喷膜制剂的制备方法,其特征在于:包括以下步骤:
步骤一、按比例称取上述原料,杉木和白芨炮制后研磨成细粉,取PVA1788、无水乙醇和蒸馏水备用;
步骤二、将PVA1788与壳聚糖盐酸盐在40℃水浴条件下加入到蒸馏水中,磁力搅拌至完全溶解;
步骤三、加入杉木粉末、白芨粉末和冰片,再加入甘油,于磁力搅拌中继续搅拌至溶解完全,放置室温待泡沫消除;
步骤四、再加入无水乙醇,搅拌均匀,放置5min后装瓶;
步骤五、分装紫外灭菌。
8.根据权利要求7所述的制备方法,其特征在于:所述杉木的炮制为烧灰存性。
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