CN107469141A - 一种微海绵医用敷料及其制备方法 - Google Patents
一种微海绵医用敷料及其制备方法 Download PDFInfo
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Abstract
本发明属于药物制剂领域,特别是一种微海绵医用敷料及其制备方法。本发明所制备的医用敷料,外观良好、吸水迅速、透气性强、稳定可靠、使用方便,适用于日常损伤、手术缝合、战场急救的止血与护理,尤其对难以包扎的部位及面积大、恢复慢的伤口治疗有良好的前景;本发明所述制备方法简单可靠,条件温和,适用范围广,易于工业化生产。
Description
技术领域
本发明属于药物制剂领域,特别是一种微海绵医用敷料及其制备方法。
背景技术
粉体医用敷料,亦称作止血粉,是近年来发展迅速的一类医用敷料,具有使用方便、吸水能力强、适用于多种伤口、应用范围广、材料类型多样等众多优势,适用于关节和腹部、颈部等难以包扎的部位和受损面积大、恢复速度慢的伤口,特别适用于火灾现场、战地损伤、重大交通事故现场等的自救与互救。
现阶段已授权的粉体医用敷料相关专利主要包括以下内容:
专利CN200710074086公开了一种沸石止血敷料及其制备方法,其沸石止血敷料通过提高伤口钙离子含量和吸水产热提高创面温度来促进血液迅速凝固。此类产品存在三个主要缺陷:一是沸石在吸收血液中水分的同时会出现吸附放热现象,瞬间使局部温度升高,接近60-70℃,容易造成创伤处烧伤;二是沸石粉状颗粒直接撒在创伤处,止血后在创伤处与血液发生凝结,由于沸石颗粒不吸收,长期残留会引起慢性炎症,因此需要后期清创处理,增加了处理伤口的难度;三是沸石密度大,不便于携带。
专利CN200610124198公开了一种可生物降解的止血粉,该产品由羧甲基纤维素、海藻酸钠、氯化钙、液体石蜡制得。该产品通过吸收血液中的水分使血细胞富集来加速凝血。但是该产品依赖内源性凝血机制,对于血友病等自身凝血机能有障碍的患者无法起到止血作用。另一方面,该产品电镜结果显示其材料表面较为圆整,比表面积较小,对血液中水分的吸收速度以及吸收量相对较少,对于动脉出血等出血量大,速度快的损伤难以起到止血作用。
专利CN201210552650公开了一种生物粉体医用敷料及其制备方法,该产品采用几丁聚糖、海藻酸盐、胶原肽、表皮生长因子、羧甲基纤维素钠、果胶为原料制备,通过将物料在搅拌机中搅拌混合后辐射灭菌制备而成。该工艺只是将物料搅拌混合,难以保障材料的均一性和有效性。此外,将粉体混合将大大增加物料的吸湿性,制剂对表皮生长因子等生物活性的保护作用难以保障,制剂稳定性存疑。
微海绵(Microsponge Delivery System,MDS),亦称多孔聚合物微球,是近年来发展的一类具有海绵样多孔外观的微小粒子给药系统,可供口服或外用。微海绵可由海藻酸盐、壳聚糖、明胶等天然材料或乙基纤维素、羧甲基纤维素、PLGA、Eudragit-RS 100等合成/半合成材料制成。其制备方法主要包括W/O/W乳液溶剂蒸发法(W/O/W emulsion solventevaporation)、半乳化溶剂扩散法(Quasi emulsion solvent diffusion)、液-液悬浮聚合法(Liquid-liquid suspension polymerization)、冻干法等。正如其名,微海绵具有与海绵相似的丰富的孔道结构,以及快速吸收大量的水分等性能。其粒径范围一般在100μm左右,少数可达到纳米级别,孔径范围通常在100~800nm左右,孔隙率可高达90%。微海绵可通过将药物包裹在孔道内或吸附于表面等多种方式进行载药,其独特的孔道结构可提供更多的液体接触面积以及药物的荷载位点。与微球等传统微小粒子相比,微海绵其独特的海绵样外观使其具有更大的比表面积、更高的吸水量以及更多的药物荷载量等诸多优势。因此微海绵在临床止血、组织工程、药物缓释等领域都有广阔的应用和需求。
发明内容
本发明的目的是通过提供一种微海绵医用敷料及其制备方法,对传统粉体医用敷料进行改良。目的要求与传统粉体医用敷料相比,通过将海藻酸盐、壳聚糖等具有一定功能性的天然聚合物材料有序地进行组合制成微海绵,在保留材料自身吸水快、可溶胀、可降解、促凝血等优势的同时构建特定的微观多孔结构,增大粉体医用敷料药物吸附面积以及与血液的接触面积,从而进一步改善粉体医用敷料的吸水性能、透气性能、实现药物的高荷载、提高制剂稳定性。目的要求所制得粉体医用敷料外观细腻,粒径均匀,电镜下可以观察到海绵状多孔形貌,接触伤口时可迅速吸收血液和创面渗出物,溶胀封堵创面,快速止血,并可用于持续释放药物促进伤口愈合。目的要求制备方法工艺简单可靠,工艺条件温和,适用范围广,且易于工业化生产。
为实现上述目的,本专利提供了如下实施方案。
在实施方案中,本发明的微海绵医用敷料,其特征在于所述微海绵医用敷料具有海绵样外观的结构,其中药物百分含量为0-50%,海藻酸盐百分含量为6.5-40%,羧甲基纤维素盐百分含量为0-70%,壳聚糖百分含量为5-70%。
所述药物为苯扎溴铵、苯扎氯铵、醋酸洗必泰、葡萄糖酸洗必泰、红霉素、庆大霉素、磺胺嘧啶银等具有广谱抑菌活性的药物或重组人表皮生长因子(hEGF)、碱性成纤维细胞生长因子(bFGF)、粒细胞-巨噬细胞集落刺激因子(GM-CSF)等促进创面愈合的生长因子中的一种或几种。
所述微海绵医用敷料电镜观察下可看见类似海绵样的疏松多孔结构,平均粒径范围在50-350μm,孔隙率在60-85%之间,表面平均孔径范围在200-600nm之间。
本发明提供了一种微海绵医用敷料的制备方法,该方法包括以下步骤:
1)取海藻酸钠和羧甲基纤维素钠,加入去离子水,溶胀并充分搅拌后得到溶液A,同时取壳聚糖加入去离子水,充分搅拌后得到溶液B。
2)将步骤1)中的溶液A添加至含表面活性剂的分散相中,充分搅拌30min至溶液成液滴均匀分散于分散相中。向反应体系中逐滴添加交联剂,搅拌15min后,加入溶液B,继续搅拌30min。
3)将步骤2)中所述混合液转移至旋转蒸发仪上,旋转蒸发20min至无明显气泡,可观察到白色悬浮颗粒,取所述悬浊液于抽滤装置中抽滤,抽滤过程中缓慢添加乙醇洗涤,重复以上操作3-4次后将滤饼送入烘箱中烘干,即得空白微海绵粉末。
4)取步骤3)所述空白微海绵于药物溶液中,缓慢搅拌,随后干燥除去溶剂,密封包装灭菌后即得微海绵医用敷料。亦可将3)所述空白微海绵与含药溶液制成糊状物涂布在适宜的背衬绷带材料上,干燥除去溶剂并灭菌后,按不同面积分割和密封包装,即得微海绵医用敷料。
上述方法中,所述的微海绵医用敷料的制备方法,其步骤2)与3)中搅拌速度为800~2000rpm,优选1000rpm;步骤3)中旋转蒸发温度为35-50℃、压力为-0.06至-0.3MPa,优选37℃、-0.1MPa;步骤3)中烘干温度为35-50℃、时间2-10h,优选45℃、4h;步骤4)中干燥方法包括旋转蒸发法、喷雾干燥法、冷冻干燥法、烘箱烘干等常用干燥方法中的一种或几种。
所述步骤2)中表面活性剂为非离子表面活性剂,主要包括吐温系列,司盘系列等山梨醇酯类、蔗糖酯类、烷基醇酰胺类等非离子表面活性剂中的一种或几种,用量占分散相质量百分比的0.2-0.8%,优选吐温80,用量0.7%;分散相主要包括乙酸乙酯、乙酸丁酯、三氯甲烷、二氯甲烷等其中的一种,优选乙酸乙酯;交联剂为钙离子、锌离子、镁离子、银离子溶液中的一种或几种,优选钙离子溶液。
本发明的优势在于:
1.本发明通过构建具有海绵样多孔外貌的微观结构,极大地提高了材料与创面血液、组织液等液体的接触面积,有利于水分的快速吸收,极大地加快了凝血速度。同时,多孔结构增大了材料的比表面积,可以有效提高药物的荷载量。
2.与传统粉体医用敷料相比,本发明在遇血液即可迅速吸收其中的水分促使血液凝固的同时,可以通过自身迅速溶胀来封堵创面,并且由于溶胀过程不产生热量,有效减少了对创面的刺激。
3.与传统粉体医用敷料相比,本发明具有的疏松多孔结构极大地减小了材料的密度,提高了产品的便携性,改善了医用敷料的透气性。
4.与传统粉体医用敷料相比,本发明将药物荷载在多孔结构内,避免药物直接与外界环境接触,提高了产品的稳定性,保障了产品本身和使用的安全可靠。
5.本发明利用材料自身的性质,将其互相贯穿连接来构建具有特定结构的微小粒子,避免了甲醛等化学交联剂的使用,较好的保留了材料自身的优良性能,提高了敷料的安全性。
6.本发明通过使用易挥发,低毒性的有机溶剂,并结合旋转蒸发工艺,有效减少了材料中有机溶剂的残留,提高了敷料的安全性,符合医用敷料对材料低毒性的需求。
7.本发明使用方便,单手即可完成对伤口的处理,并且应用范围广,作用迅速,尤其适用战地、火灾、重大交通事故等情况伤员的自救与互救。
附图说明
图1为微海绵医用敷料的结构示意图,图1标注[1]为海藻酸钠和羧甲基纤维素钠、标注[2]为药物、标注[3]为壳聚糖。
图2为实施例2的扫描电镜照片。
图3为实施例2的粒度分布图。
图4为实施例2的孔隙分布图。
具体实施方式
以下实施例用于说明本发明,但不用来限制本发明的范围。所以,在本发明的方法前提下对本发明的简单改进均属本发明要求保护的范围。
实施例1
【处方】
【制备】
取海藻酸钠与羧甲基纤维素钠,加入100ml去离子水,充分溶胀并搅拌均匀后得到均一的溶液A,取壳聚糖加入20ml去离子水,充分搅拌至得到均一的溶液B。将聚合物溶液A缓慢加入持续搅拌的含有0.2%吐温80的乙酸丁酯中,800rpm充分搅拌30min至液滴均匀分散,向分散装置中逐滴加10%氯化钙溶液,800rpm充分搅拌15min后随即加入溶液B,继续搅拌30min。将反应体系移至旋转蒸发仪上,37℃、-0.1MPa旋转蒸发约20min至不再产生细密泡沫,得到含有预制微海绵的悬浊液。将所得悬浊液用抽滤装置抽滤,抽滤过程中缓慢添加乙醇洗涤,重复洗涤3次后将滤饼于45℃烘箱中烘干4h,得到空白微海绵粉末。取1g空白微海绵于100ml的0.002g/ml的醋酸洗必泰乙醇溶液中,缓慢搅拌1h后37℃、-0.1MPa旋转蒸发除去溶剂,送入45℃烘箱充分干燥后密封包装灭菌后即得微海绵医用敷料。
实施例2
【处方】
【制备】
取海藻酸钠与羧甲基纤维素钠,加入100ml去离子水,充分溶胀并搅拌均匀后得到均一的溶液A,取壳聚糖加入20ml去离子水,充分搅拌至得到均一的溶液B。将聚合物溶液A缓慢加入100ml持续搅拌的含有0.7%吐温80的乙酸乙酯中,1000rpm充分搅拌30min至液滴均匀分散,向分散体系中逐滴加10%氯化钙溶液,1000rpm充分搅拌15min后随即加入溶液B,继续搅拌30min。将反应体系移至旋转蒸发仪上,37℃、-0.1MPa旋转蒸发20min至不再产生细密泡沫,得到含有预制微海绵的悬浊液。将所得悬浊液用抽滤装置抽滤,抽滤过程中缓慢滴加乙醇洗涤,重复洗涤3次后将滤饼于45℃烘箱中烘干4h,得到空白微海绵粉末。取1g空白微海绵于100ml的0.001g/ml的苯扎溴铵乙醇溶液中,缓慢搅拌1h后37℃、-0.1MPa旋转蒸发除去溶剂,送入45℃烘箱充分干燥后密封包装灭菌后即得微海绵医用敷料。
实施例3
【处方】
【制备】
取海藻酸钠与羧甲基纤维素钠,加入100ml去离子水,充分溶胀并搅拌均匀后得到均一的溶液A,取壳聚糖加入20ml去离子水,充分搅拌至得到均一的溶液B。将聚合物溶液A缓慢加入100ml持续搅拌的含有0.5%吐温80的乙酸丁酯中,1500rpm充分搅拌30min,待溶液成液滴均匀分散后向分散体系中逐滴加10%氯化钙溶液,1500rpm充分搅拌15min后随即加入溶液B,继续搅拌30min。将反应体系移至旋转蒸发仪上,40℃,-0.1MPa旋转蒸发20min至不再产生细密泡沫,得到含有预制微海绵的悬浊液。将所得悬浊液用抽滤装置抽滤,抽滤过程中缓慢滴加乙醇洗涤,重复洗涤3次后将滤饼于45℃烘箱中烘干2h,得到空白微海绵粉末。取1g空白微海绵于等体积的0.01g/ml的红霉素溶液中,充分搅拌成糊状后将糊状物均匀地涂布在无纺布绷带上,充分干燥并灭菌后将材料切割成5cm×5cm的布块,密封包装即得微海绵医用敷料。
实施例4
【处方】
【制备】
取1.5g海藻酸钠,加入100ml去离子水,充分溶胀并搅拌均匀后得到均一的溶液A,取0.66g壳聚糖加入20ml水,充分搅拌至得到均一的溶液B。将聚合物溶液A缓慢加入100ml持续搅拌的含有0.2%吐温80的二氯甲烷中,1000rpm充分搅拌30min,待溶液成液滴均匀分散后向分散体系中逐滴加10%氯化钙溶液,1000rpm充分搅拌15min后随即加入溶液B,继续搅拌30min。将反应体系移至旋转蒸发仪上,35℃、-0.08MPa旋转蒸发20min至不再产生细密泡沫,得到含有预制微海绵的悬浊液。将所得悬浊液用抽滤装置抽滤,抽滤过程中缓慢滴加乙醇洗涤,重复洗涤3次后将滤饼于50℃烘箱中烘干10h,得到空白微海绵粉末。取1g空白微海绵于50ml的0.001g/ml的葡萄糖酸洗必泰乙醇溶液中,缓慢搅拌1h后-50℃冷冻干燥30h除去溶剂,密封包装灭菌后即得微海绵医用敷料。
实施例5
【处方】
【制备】
取1.5g海藻酸钠与2g羧甲基纤维素钠,加入100ml去离子水,充分溶胀并搅拌均匀后得到均一的溶液A,取0.66g壳聚糖加入20ml水,充分搅拌至得到均一的溶液B。将聚合物溶液A缓慢加入100ml持续搅拌的含有0.5%司盘80的三氯甲烷中,2000rpm充分搅拌30min,待溶液成液滴均匀分散后向分散体系中逐滴加10%的氯化钙溶液,2000rpm充分搅拌15min后随即加入溶液B,继续搅拌30min。将反应体系移至旋转蒸发仪上,35℃、-0.08MPa旋转蒸发20min至不再产生细密泡沫,得到含有预制微海绵的悬浊液。将所得悬浊液用抽滤装置抽滤,抽滤过程中缓慢滴加乙醇洗涤,重复洗涤4次后将滤饼于50℃烘箱中烘干10h,得到空白微海绵粉末。取1g空白微海绵于50ml的30AU/ml的碱性成纤维细胞生长因子(bFGF)水溶液中,缓慢搅拌1h后在进风口110℃、出风口60℃、压强-50mbar条件下喷雾干燥除去溶剂,随后密封包装灭菌后即得微海绵医用敷料。
实施例6
【处方】
【制备】
取1.5g海藻酸钠与2g羧甲基纤维素钠,加入100ml去离子水,充分溶胀并搅拌均匀后得到均一的溶液A,取0.66g壳聚糖加入20ml去离子水,充分搅拌至得到均一的溶液B。将聚合物溶液A缓慢加入100ml持续搅拌的含有0.5%司盘80的二氯甲烷中,2000rpm充分搅拌30min,待溶液成液滴均匀分散后向分散体系中逐滴加10ml的0.1g/ml的氯化钙溶液,2000rpm充分搅拌15min后随即加入溶液B,继续搅拌30min。将反应体系移至旋转蒸发仪上,35℃、-0.8MPa旋转蒸发20min至不再产生细密泡沫,得到含有预制微海绵的悬浊液。将所得悬浊液用抽滤装置抽滤,抽滤过程中缓慢滴加乙醇洗涤,重复洗涤4次后将滤饼于50℃烘箱中烘干10h,得到空白微海绵粉末。取1g空白微海绵于50ml的60IU/ml的重组人表皮生长因子(hEGF)水溶液中,缓慢搅拌1h后-50℃冷冻干燥30h除去溶剂,随后密封包装灭菌后即得微海绵医用敷料。
实施例7
将实施例2、6、7中所述微海绵医用敷料按1∶1∶1的比例混合,充分搅拌至混合均匀后再次干燥并灭菌,随后密封包装,即得复方微海绵医用敷料。
实施例8
形态学考察
实验方法:用扫描电镜对实施例2所得微海绵医用敷料进行形态学考察,剪取1cm导电胶粘在金属样品台上后,取约0.05g样品于导电胶上,用小药匙刮除多余的样品使其成薄薄的一层。然后将样品连带样品台放在真空蒸发器中喷镀一层厚的金属膜。待喷膜完成后将样品放入场发射扫描电镜的样品室中,通过电脑软件调节焦距使屏幕上呈现清晰的物象。
实验结果如图2所示,所制微海绵医用敷料粉末粒径约100μm,颗粒整体外形圆整,表面呈类似海绵样外观,孔隙丰富。
实施例9
粒度分布考察
实验方法:用马尔文微米粒径仪对实施例2所得微海绵医用敷料进行粒度考察。以无水乙醇作为分散介质,调校仪器至基线稳定,加入样品直至仪器显示遮光度范围在10-15%范围内,点击开始测定,平行测定三次,用系统自带软件处理实验结果。
实验结果如图3所示,所制微海绵医用敷料平均粒径(d0.5)为85.881μm,粒径分布较为均匀。
实施例10
孔径分布考察
实验方法:用全自动压汞孔径测试仪对实施例2所得微海绵医用敷料进行孔径分布考察。精密称取样品0.1g于样品管中,将样品管安装于全自动压汞孔径测试仪上,启动软件开始测试,软件自动输出实验结果。
实验结果如图4所示,所制微海绵医用敷料样品平均孔径为534.33nm,孔隙率为85.7809%。
Claims (8)
1.一种微海绵医用敷料及其制备方法,其特征在于所述微海绵医用敷料具有海绵样外观结构,其中药物百分含量为0-50%,海藻酸盐百分含量为6.5-40%,羧甲基纤维素盐百分含量为0-70%,壳聚糖百分含量为5-70%。
一种微海绵医用敷料制备方法,其特征在于包括以下步骤:
1)取海藻酸钠和羧甲基纤维素钠,加入去离子水,溶胀溶解后得到溶液A,同时取壳聚糖加入去离子水,溶胀溶解后得溶液B;
2)将步骤1)中的溶液A添加至含表面活性剂的分散相中,搅拌30min至溶液成液滴状均匀分散于分散相中,向反应体系中逐滴添加交联剂,搅拌15min后,加入溶液B,继续搅拌30min;
3)将步骤2)中所述混合液转移至旋转蒸发仪上,旋转蒸发约20min至无明显气泡,可见白色悬浮颗粒,取所述悬浊液于抽滤装置中抽滤,抽滤过程中缓慢添加乙醇洗涤,重复以上操作3-4次后将滤饼置烘箱中烘干,即得空白微海绵粉末;
4)取步骤3)所述空白微海绵于药物的溶液中,缓慢搅拌,随后干燥除去溶剂,灭菌后密封包装,即得微海绵医用敷料;亦可将3)所述空白微海绵与含药溶液制成糊状物涂布在适宜的背衬材料上,干燥除去溶剂并灭菌后,按不同面积分割和密封包装,即得微海绵医用敷料。
2.如权利要求1所述的微海绵医用敷料,其特征在于:所述药物选自苯扎溴铵、苯扎氯铵、醋酸洗必泰、葡萄糖酸洗必泰、红霉素、庆大霉素、磺胺嘧啶银等具有广谱抑菌活性的药物或重组人表皮生长因子(hEGF)、碱性成纤维细胞生长因子(bFGF)、粒细胞-巨噬细胞集落刺激因子(GM-CSF)等生长因子中的一种或几种。
3.如权利要求1所述的微海绵医用敷料,其特征在于:所述微海绵医用敷料电镜观察下可看见类似海绵样的疏松多孔结构,平均粒径范围在20-350μm,孔隙率在70-90%之间,表面平均孔径范围在200-600nm之间。
4.如权利要求1所述的微海绵医用敷料的制备方法,其特征在于:步骤2)与3)中搅拌速度为800-2000rpm;步骤3)中旋转蒸发温度为35-50℃、压力为-0.3至-0.06MPa;步骤3)中烘干温度为35-50℃、时间2-10h;步骤4)中干燥方法包括旋转蒸发法、喷雾干燥法、冷冻干燥法、烘箱烘干等常用干燥方法中的一种或几种。
5.如权利要求1所述的微海绵医用敷料的制备方法,其特征在于:所述表面活性剂为山梨醇酯类、蔗糖酯类、烷基醇酰胺类等非离子表面活性剂中的一种或几种,用量占分散相质量百分比的0.2-0.8%。
6.如权利要求1所述的微海绵医用敷料的制备方法,其特征在于:所述分散相主要包括乙酸乙酯、乙酸丁酯、三氯甲烷、二氯甲烷等其中的任意一种。
7.如权利要求1所述的微海绵医用敷料的制备方法,其特征在于:所述交联剂为钙离子、锌离子、镁离子、银离子溶液中的一种或几种。
8.根据权利要求1-7所述的微海绵医用敷料的应用,其特征在于:适用于日常割伤、擦伤、烧伤、烫伤、手术缝合、以及战场损伤等各类损伤损伤的止血和护理;对于腹部、颈部、关节处等难以进行包扎或包扎后创口易损伤渗血的部位以及面积大、恢复慢、易感染的伤口可以期待较好的疗效。
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