CN107096064B - 一种可快速膨胀的超多孔复合止血材料的制备方法 - Google Patents
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Abstract
本发明涉及一种可快速膨胀的超多孔复合止血材料及其制备方法及应用。本发明的超多孔复合止血材料是把介孔活性玻璃、壳聚糖、起泡剂和不同聚丙烯酰胺单体混合并随后引发形成气泡和聚丙烯酰胺,最终获得包含介孔活性玻璃,壳聚糖和聚丙稀酰胺三种组分的超多孔结构。本发明的超多孔复合止血材料遇血液能快速膨胀并能快速促进血液凝固,同时具有良好的抗菌性和生物相容性。本发明所述的超多孔复合止血材料能快速对动脉出血进行止血,优于由介孔活性玻璃或壳聚糖单组分的或由介孔活性玻璃和壳聚糖双组份组成的止血材料。
Description
技术领域
本发明涉及一种复合止血材料及其制备技术,特别涉及一种可快速膨胀的超多孔复合止血材料,以及该超多孔复合止血材料的构成方法和应用,属于生物医用材料领域。
背景技术
在日常生活中,对因各种原因导致的局部出血进行快速止血非常重要。尤其是对那些大量动脉出血的患者,尽早的控制动脉出血成为降低患者死亡的最佳策略。对于动脉的出血,理想的止血材料应该是能快速膨胀并能使血液快速凝固,这样就可以使破损的动脉能快速被堵塞并快速凝血形成血栓,从而阻止血液流失。与此同时,该材料还应该具有良好的生物相容性和抗菌性。这样就可以避免患处产生感染或排异反应。
目前,人们已经发现或研制出许多止血材料,包括可溶性蛋白如纤维蛋白,胶原蛋白,多孔沸石,活性玻璃,壳聚糖,改性淀粉等。而且这些材料大都已经被开发作为商品。例如商品名为Quikclot的多孔沸石,商品名Celox的壳聚糖“速效止血粉”,商品名perelot的改性淀粉止血粉,成分为木浆和壳聚糖的双组分的Xstat的止血片等。尽管这些产品都有止血的功能,但是各有缺陷,很难满足作为动脉快速止血的要求。例如多孔沸石在使用中会放热,从而容易烧伤组织;由改性淀粉或和壳聚糖复合的止血产品的止血时间较长,不利于快速止血。
为了加快止血,最近一篇题为《介孔生物活性玻璃-壳聚糖止血材料的制备及研究》的硕士论文和专利号为CN201010525865.1的专利“介孔生物活性玻璃和壳聚糖复合多孔止血材料及制备方法”报道了把具有介孔的生物活性玻璃和壳聚糖相结合制备成多孔复合材料可以加速血液的凝聚,其凝血时间优于美国Starch Medical Inc公司的perelot止血粉。如此的材料能降低止血时间是因为具有介孔的生物活性玻璃既具有丰富的介孔,又有能快速释放钙离子,从而加速了血液的凝聚。另外,因为活性玻璃含有Ag2O成分,该成分赋予活性玻璃很好的抗菌性。与此同时,具有多孔的带正电荷壳聚糖也能加速血液的凝聚和抗菌性。另外,活性玻璃和壳聚糖已经被证实具有良好的生物相容性。因此,把具有介孔结构的生物活性玻璃和带正电荷的壳聚糖相复合制备成多孔材料不但能提高凝血时间,而且还有良好的抗菌性和生物相容性。尽管如此,介孔生物活性玻璃和壳聚糖的复合材料不具备膨胀性能,因此这种材料不能以膨胀堵塞的方式止血。
发明内容
针对当前止血材料存在的缺陷和不足,本发明提出一种遇血液能快速膨胀,能快速促进血液凝固,同时具有良好的抗菌性和生物相容性的止血材料及其制备方法和应用。
本发明所述的技术方案为:一种可快速膨胀的超多孔复合止血材料,其是由介孔活性玻璃、壳聚糖和聚丙烯酰胺三种组分复合而成,具有超多孔结构;进一步地,所述的介孔活性玻璃、壳聚糖和聚丙烯酰胺的重量比为(1-3):(0.1-0.5):(2-5);
进一步地,所述的介孔活性玻璃的组分包括SiO2,CaO,P2O5和Ag2O;
进一步地,所述的介孔活性玻璃的孔隙直径为2-100纳米;
进一步地,所述的超多孔结构的孔直径为10-1000微米,孔隙率为60-90%。
为实现上述目的,本发明是采用以下措施构成的技术方案来实现的。
本发明所述的可快速膨胀的超多孔复合止血材料,按照如下步骤制备:
A)把水、介孔活性玻璃粉末、壳聚糖、起泡剂碳酸氢钠和不同的聚丙烯酰胺单体,包括丙烯酰胺、N,N-亚甲基-双丙烯酰胺、过硫酸铵和四甲基乙二胺混合形成混合物M;
B)对混合物M进行搅拌引发产生气泡,然后放置到温度为25-50℃,湿度为70-100%的环境中反应6-96小时,获得由介孔活性玻璃粉末、壳聚糖和聚丙烯酰胺组成的复合材料;
C)由介孔活性玻璃粉末、壳聚糖和聚丙烯酰胺组成的复合材料在25-50℃无水乙醇浸泡12-48小时,然后放入真空干燥器中干燥并除去残余乙醇,获得可快速膨胀的超多孔复合止血材料;
上述方案中,所述的丙烯酰胺、N,N-亚甲基-双丙烯酰胺、过硫酸铵和四甲基乙二胺的重量比为(30-50):(5-20):(1-5):(1-5)。
本发明具有以下特点及有益的技术效果:
本发明的快速膨胀的超多孔复合止血材料,遇到血液后能快速膨胀,其膨胀体积在30秒内可达本体材料3倍左右。由于具有膨胀的特点,超多孔复合止血材料在放入动脉血管后,快速牢固的堵塞在血管内。从而起到物理止血作用。
与此同时,超多孔复合止血材料被证实具有比介孔活性玻璃和壳聚糖双组分复合止血材料更短的止血时间。本发明的超多孔复合止血材料有快速凝固血液的原因是除了介孔活性玻璃和壳聚糖两种组分对血液的凝固外,该材料的快速膨胀过程快速吸收并浓缩血液,从而加速了血液的凝固。因此本发明的由三种组分构成的超多孔复合止血材料在止血过程中的各项性能都优于单一组分或双组分的止血材料。
附图说明:
图1是本发明实施例1所使用的介孔活性玻璃的TEM图片;
图2是本发明实施例1所使用的由介孔活性玻璃、壳聚糖和聚丙烯酰胺的超多孔复合止血材料的SEM图片。
具体实施方式
下面用具体实施例对本发明作进一步的详细说明,但不应理解为是对本发明保护内容的任何限定。
实施例1可快速膨胀的超多孔复合止血材料的制备
A)把3.0克水、0.1克如图1所示的孔径为10纳米的、包含SiO2、CaO,P2O5和Ag2O的介孔活性玻璃粉末、0.05克壳聚糖、0.2克起泡剂碳酸氢钠和不同的聚丙烯酰胺单体,包括0.2克丙烯酰胺,0.033克N,N-亚甲基-双丙烯酰胺,0.010克过硫酸铵和0.015克四甲基乙二胺混合形成混合物M;
B)对混合物M进行搅拌引发产生气泡,然后放置到温度为400℃,湿度为90%的环境中反应12小时,获得由介孔活性玻璃粉末、壳聚糖和聚丙烯酰胺组成的复合材料;
C)由介孔活性玻璃粉末、壳聚糖和聚丙烯酰胺组成的复合材料在40℃无水乙醇浸泡40小时,然后放入真空干燥器中干燥并除去残余乙醇,获得如图2所示孔径为500微米、孔隙率为85%的、可快速膨胀的、含介孔活性玻璃、壳聚糖和聚丙稀酰胺的超多孔复合止血材料。
其中,介孔活性玻璃、壳聚糖和聚丙稀酰胺的重量比为1:0.5:2.3。获得可快速膨胀的超多孔复合止血材料。
实施例2动脉止血实施例
使用健康成年SD大鼠16只,体重为190±15克,由成都高新区实验动物中心提供,随机分成4组,每组4只,第一组为纯介孔生物活性玻璃粉,第二组为Celox壳聚糖速效止血粉,第三组为介孔生物玻璃-壳聚糖多孔复合止血材料,第四组为介孔生物玻璃-壳聚糖-聚丙烯酰胺复合超多孔止血材料。大鼠腹腔注射戊巴比妥钠40mg/kg,麻醉后把其仰面固定在手术台上。剥离劲总动脉~2厘米,夹住近心端,用可降解手术线扎住另一端,沿动脉横向剪一切口,从切口处插入导管并固定。打开近心端止血夹,导管与生理仪相连。静脉注射肝素300U/kg。腹股沟部去毛,用碘酒和酒精棉球消毒,剥离股动脉,用止血夹夹住近心端,将动脉横向剪开占直径1/3的切口。立即擦去喷出的血液,立即纱布压住。然后缓慢松开医用纱布并立即对出血部位施加止血材料,再用医用纱布适当压力压住,并开始计时。一定时间后拿开棉球,观察不同材料的止血效果,必要时可增加使用止血材料,以后每5分钟观察一次,直到完全止血为止,记录止血时间及出血量。实验方法详见专利号为CN201010525865.1的专利“介孔生物活性玻璃和壳聚糖复合多孔止血材料及制备方法”。
表1不同止血材料的出血时间及出血量
测试材料 | 止血时间(秒) | 出血量(克) |
纯介孔生物活性玻璃粉 | 76±4.0 | 0.81±0.09 |
Celox壳聚糖速效止血粉 | 67±6.0 | 0.72±0.07 |
介孔活性玻璃-壳聚糖多孔复合止血材料 | 58±3.0 | 0.60±0.05 |
介孔活性玻璃-壳聚糖-聚丙烯酰胺超多孔复合止血材料 | 31±3.0 | 0.50±0.03 |
本实施例结果充分说明由介孔活性玻璃、壳聚糖和聚丙烯酰胺三种组分制备的超多孔复合止血材料显示出最短的止血时间以及最小的出血量,优于同条件下单一组份的介孔活性玻璃或者由多米尼加共和国VEXXUS Medical Inc公司生产的Celox壳聚糖速效止血粉止血效果,以及由介孔活性玻璃和壳聚糖双组份构成的复合止血材料的止血效果。
Claims (7)
1.一种可快速膨胀的超多孔复合止血材料的制备方法,其特征在于,超多孔复合止血材料是由介孔活性玻璃、壳聚糖和聚丙烯酰胺三种组分复合而成,具有超多孔结构;制备方法包括如下步骤:
A)把水、介孔活性玻璃粉末、壳聚糖、起泡剂碳酸氢钠、丙烯酰胺、N,N-亚甲基-双丙烯酰胺、过硫酸铵和四甲基乙二胺混合形成混合物M;
B)对混合物M进行搅拌引发产生气泡,然后放置到温度为25-50℃,湿度为70-100%的环境中反应6-96小时,获得由介孔活性玻璃粉末、壳聚糖和聚丙烯酰胺组成的复合材料;
C)由介孔活性玻璃粉末、壳聚糖和聚丙烯酰胺组成的复合材料在25-50℃无水乙醇浸泡12-48小时,然后放入真空干燥器中干燥并除去残余乙醇,获得可快速膨胀的超多孔复合止血材料。
2.根据权利要求1所述的可快速膨胀的超多孔复合止血材料的制备方法,其特征在于,所述的介孔活性玻璃、壳聚糖和聚丙烯酰胺的重量比为(1-3)∶(0.1-0.5)∶(2-5)。
3.根据权利要求1或2所述的可快速膨胀的超多孔复合止血材料的制备方法,其特征在于,所述的介孔活性玻璃的组分包括SiO2、CaO、P2O5和Ag2O。
4.根据权利要求1所述的可快速膨胀的超多孔复合止血材料的制备方法,其特征在于,所述的介孔活性玻璃的孔隙直径为2-100纳米。
5.根据权利要求1所述的可快速膨胀的超多孔复合止血材料的制备方法,其特征在于,所述的超多孔结构的孔直径为10-1000微米。
6.根据权利要求1或5所述的可快速膨胀的超多孔复合止血材料的制备方法,其特征在于,所述的超多孔结构的孔隙率为70-90%。
7.根据权利要求1所述的可快速膨胀的超多孔复合止血材料的制备方法,其特征在于,所述的丙烯酰胺、N,N-亚甲基-双丙烯酰胺、过硫酸铵和四甲基乙二胺的重量比为(30-50)∶(5-20)∶(1-5)∶(1-5)。
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