CN109125790A - 一种采用壳聚糖制作的止血海绵结构 - Google Patents
一种采用壳聚糖制作的止血海绵结构 Download PDFInfo
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Abstract
本发明公开了一种采用壳聚糖制作的止血海绵结构,所述止血海绵结构两侧表面设置止血海绵层,止血海绵层之间设置载药层,载药层和止血海绵层之间粘结,所述载药层内部填充物为止血中药粉末为槐花、紫珠草或仙鹤草粉末中的一种或多种混合物;本发明能够迅速强效止血,无毒无刺激性,使用安全性高,本发明提供的快速止血壳聚糖海绵垫止血海绵,兼具抗菌、镇痛、止痛、促进伤口愈合等作用,本发明提供的快速止血壳聚糖海绵垫止血海绵,制备方法简便易行,制作成本低,适用于医用快速止血和促进伤口愈合等方面。
Description
技术领域
本发明涉及医用海绵技术领域,具体是一种采用壳聚糖制作的止血海绵结构。
背景技术
在各种外科手术中,减少出血,缩短手术时间,对患者病愈后有着重要影响。近年来,用于体内的医用可吸收止血海绵引起了各国医学界和产业界的高度重视。该海绵需满足下面要求:1、良好的生物相容性,细胞相容性和组织相容性。生物相容性是指生命有机体组织对活性材料产生反应的一种性能。医用海绵要植入体内,至少要使发生的反应为宿主所接收,不产生有害的毒性作用,2、良好的生物降解性。医用海绵在人体内进水解、酶解等过程,逐渐降解成低分子量化合物或单体,降解产物能被排出体外或能参加体内正常新陈代谢而消失,降解产物应对细胞无毒害作用。3、具有三维立体多孔结构和较高的孔隙率。这种结构可提供大的表面积和空间,提高吸收积液的速度和容量。4、可塑性和一定的机械强度。所以材料具有良好的可塑性,易于加工成型并具有一定的机械强度。医用海绵是目前在临床获得广泛应用的止血材料,主要包括明胶海绵和胶原海绵。明胶海绵的缺点是亲水性差,吸血量小,黏附性较差,易于脱落,且容易引起伤口的感染;而胶原海绵则存在力学性能差、溶解速度太快等缺陷。近年来,纤维素及其衍生物、甲壳素及其衍生物及海藻酸钙等作为医用止血材料也获得了广泛的研究和关注。壳聚糖是自然界植物体内存在的一种高分子化合物,能被人体α-淀粉酶分解为葡萄糖,最后代谢为水和二氧化碳,壳聚糖是自然界最丰富的可再生资源之一,具有良好的生物相容性和可降解性、无毒副作用、无刺激性、代谢机理明确,不会在体内沉积而引起炎症,可被人体充分吸收,分解的产物完全无毒的优点,是制备可吸收止血材料的理想原料,在生物医学领域有广阔的应用前景;粉状壳聚糖止血材料已在临床应用,并显示出吸水止血速度快、吸血量大等优点,但也存在使用不方便等缺点,因此需要采用适当的方法将其加工成型。
发明内容
本发明的目的在于提供一种采用壳聚糖制作的止血海绵结构,以解决上述背景技术中提出的问题。
为实现上述目的,本发明提供如下技术方案:
一种采用壳聚糖制作的止血海绵结构,所述止血海绵结构两侧表面设置止血海绵层,止血海绵层之间设置载药层,载药层和止血海绵层之间粘结;所述载药层内部填充物为止血中药粉末为槐花、紫珠草或仙鹤草粉末中的一种或多种混合物。
所述采用壳聚糖制作的止血海绵结构的制备方法,步骤如下:
S1、50-100ml稀酸溶解0.1-0.8g低分子量的壳聚糖,配成壳聚糖/稀酸溶液;
S2、将NH2-CNTs加入壳聚糖/稀酸溶液中,控制NH2-CNTs的质量百分含量为20-55%,超声分散20-35min,得到分散均匀的NH2-CNTs溶液;
S3、称取0.1-0.5g氧化再生纤维素,放入上述NH2-CNTs溶液中浸渍2-4h,浸渍结束后,用洗涤剂洗涤5-10次,最后将洗涤后的氧化再生纤维素-10℃--20℃预冻15-20h,预冻后放入冷冻干燥机中,在温度-46℃--10℃、真空度10-40Pa的条件下处理8-20h,得到壳聚糖复合止血材料;
S4、取出步骤S3制得的壳聚糖复合止血材料,将快速止血药剂均匀喷于壳聚糖复合止血材料上,然后采用干燥箱在70-90℃下干燥0.5-2h,得止血海绵层;
S5:将步骤S4制得的止血海绵层粘贴在粘胶布中段,并在粘胶布和海绵垫层表面覆盖隔离纸,即得。
作为本发明再进一步的方案:在步骤S2中所述壳聚糖的分子量为500-5000,壳聚糖/稀酸溶液中所用稀酸溶剂体积分数为1-5%,稀酸溶剂为醋酸;在步骤S3中洗涤剂为无水乙醇或丙酮中的一种。
作为本发明再进一步的方案:在步骤S4中快速止血药剂包括以下按照重量份的原料:葡萄糖水溶液12-20份、甘露糖7-20份、明胶1-8份、胶原蛋白5-15份、海藻酸钠10-20份、改性淀粉20-40份、交联剂3-8份。
作为本发明再进一步的方案:在步骤S4中快速止血药剂包括以下按照重量份的原料:葡萄糖水溶液15-18份、甘露糖9-15份、明胶3-6份、胶原蛋白8-12份、海藻酸钠12-18份、改性淀粉25-35份、交联剂4-7份。
作为本发明再进一步的方案:所述的交联剂为戊二醛、甲醛、钙盐、京尼平或丹宁酸中的一种。
与现有技术相比,本发明的有益效果是:本发明能够迅速强效止血,无毒无刺激性,使用安全性高,本发明提供的快速止血壳聚糖海绵垫止血海绵,兼具抗菌、镇痛、止痛、促进伤口愈合等作用,本发明提供的快速止血壳聚糖海绵垫止血海绵,制备方法简便易行,制作成本低,适用于医用快速止血和促进伤口愈合等方面。
具体实施方式
下面将结合本发明实施例中的附图,对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
实施例1
一种采用壳聚糖制作的止血海绵结构,所述止血海绵结构两侧表面设置止血海绵层,止血海绵层之间设置载药层,载药层和止血海绵层之间粘结;所述载药层内部填充物为止血中药粉末为槐花。
所述采用壳聚糖制作的止血海绵结构的制备方法,步骤如下:
S1、50ml稀酸溶解0.1g低分子量的壳聚糖,配成壳聚糖/稀酸溶液;
S2、将NH2-CNTs加入壳聚糖/稀酸溶液中,控制NH2-CNTs的质量百分含量为20%,超声分散20min,得到分散均匀的NH2-CNTs溶液;
S3、称取0.1g氧化再生纤维素,放入上述NH2-CNTs溶液中浸渍2h,浸渍结束后,用洗涤剂洗涤5次,最后将洗涤后的氧化再生纤维素-10℃预冻15h,预冻后放入冷冻干燥机中,在温度-46℃真空度10Pa的条件下处理8h,得到壳聚糖复合止血材料;
S4、取出步骤S3制得的壳聚糖复合止血材料,将快速止血药剂均匀喷于壳聚糖复合止血材料上,然后采用干燥箱在70℃下干燥0.5h,得止血海绵层;
S5:将步骤S4制得的止血海绵层粘贴在粘胶布中段,并在粘胶布和止血海绵垫层表面覆盖隔离纸,即得。
在步骤S2中所述壳聚糖的分子量为500,壳聚糖/稀酸溶液中所用稀酸溶剂体积分数为1%,稀酸溶剂为醋酸;在步骤S3中洗涤剂为无水乙醇。
在步骤S4中快速止血药剂包括以下按照重量份的原料:葡萄糖水溶液12份、甘露糖7份、明胶1份、胶原蛋白5份、海藻酸钠10份、改性淀粉20份、交联剂3份。
所述的交联剂为戊二醛。
实施例2
一种采用壳聚糖制作的止血海绵结构,所述止血海绵结构两侧表面设置止血海绵层,止血海绵层之间设置载药层,载药层和止血海绵层之间粘结;所述载药层内部填充物为止血中药粉末为仙鹤草粉末。
所述采用壳聚糖制作的止血海绵结构的制备方法,步骤如下:
S1、100ml稀酸溶解0.8g低分子量的壳聚糖,配成壳聚糖/稀酸溶液;
S2、将NH2-CNTs加入壳聚糖/稀酸溶液中,控制NH2-CNTs的质量百分含量为55%,超声分散35min,得到分散均匀的NH2-CNTs溶液;
S3、称取0.5g氧化再生纤维素,放入上述NH2-CNTs溶液中浸渍4h,浸渍结束后,用洗涤剂洗涤10次,最后将洗涤后的氧化再生纤维素-20℃预冻20h,预冻后放入冷冻干燥机中,在温度-10℃、真空度40Pa的条件下处理20h,得到壳聚糖复合止血材料;
S4、取出步骤S3制得的壳聚糖复合止血材料,将快速止血药剂均匀喷于壳聚糖复合止血材料上,然后采用干燥箱在90℃下干燥2h,得止血海绵层;
S5:将步骤S4制得的止血海绵层粘贴在粘胶布中段,并在粘胶布和止血海绵垫层表面覆盖隔离纸,即得。
在步骤S2中所述壳聚糖的分子量为5000,壳聚糖/稀酸溶液中所用稀酸溶剂体积分数为5%,稀酸溶剂为醋酸;在步骤S3中洗涤剂为无水乙醇。
在步骤S4中快速止血药剂包括以下按照重量份的原料:葡萄糖水溶液20份、甘露糖20份、明胶8份、胶原蛋白15份、海藻酸钠20份、改性淀粉0份、交联剂8份。
在步骤S4中快速止血药剂包括以下按照重量份的原料:葡萄糖水溶液18份、甘露糖15份、明胶6份、胶原蛋白12份、海藻酸钠18份、改性淀粉35份、交联剂7份。
所述的交联剂为钙盐。
实施例3
一种采用壳聚糖制作的止血海绵结构,所述止血海绵结构两侧表面设置止血海绵层,止血海绵层之间设置载药层,载药层和止血海绵层之间粘结;所述载药层内部填充物为止血中药粉末仙鹤草粉末。
所述采用壳聚糖制作的止血海绵结构的制备方法,步骤如下:
S1、60ml稀酸溶解0.2g低分子量的壳聚糖,配成壳聚糖/稀酸溶液;
S2、将NH2-CNTs加入壳聚糖/稀酸溶液中,控制NH2-CNTs的质量百分含量为55%,超声分散35min,得到分散均匀的NH2-CNTs溶液;
S3、称取0.1g氧化再生纤维素,放入上述NH2-CNTs溶液中浸渍4h,浸渍结束后,用洗涤剂洗涤10次,最后将洗涤后的氧化再生纤维素-20℃预冻20h,预冻后放入冷冻干燥机中,在温度-10℃真空度40Pa的条件下处理20h,得到壳聚糖复合止血材料;
S4、取出步骤S3制得的壳聚糖复合止血材料,将快速止血药剂均匀喷于壳聚糖复合止血材料上,然后采用干燥箱在90℃下干燥2h,得止血海绵层;
S5:将步骤S4制得的止血海绵层粘贴在粘胶布中段,并在粘胶布和止血海绵垫层表面覆盖隔离纸,即得。
在步骤S2中所述壳聚糖的分子量为1000,壳聚糖/稀酸溶液中所用稀酸溶剂体积分数为2%,稀酸溶剂为醋酸;在步骤S3中洗涤剂为丙酮。
在步骤S4中快速止血药剂包括以下按照重量份的原料:葡萄糖水溶液15份、甘露糖9份、明胶3份、胶原蛋白8份、海藻酸钠12份、改性淀粉25份、交联剂4份。
所述的交联剂为戊二醛。
实施例4
一种采用壳聚糖制作的止血海绵结构,所述止血海绵结构两侧表面设置止血海绵层,止血海绵层之间设置载药层,载药层和止血海绵层之间粘结;所述载药层内部填充物为止血中药粉末为紫珠草。
所述采用壳聚糖制作的止血海绵结构的制备方法,步骤如下:
S1、100ml稀酸溶解0.1g低分子量的壳聚糖,配成壳聚糖/稀酸溶液;
S2、将NH2-CNTs加入壳聚糖/稀酸溶液中,控制NH2-CNTs的质量百分含量为20%,超声分散20min,得到分散均匀的NH2-CNTs溶液;
S3、称取0.1g氧化再生纤维素,放入上述NH2-CNTs溶液中浸渍4h,浸渍结束后,用洗涤剂洗涤10次,最后将洗涤后的氧化再生纤维素-20℃预冻20h,预冻后放入冷冻干燥机中,在温度-10℃、真空度40Pa的条件下处理20h,得到壳聚糖复合止血材料;
S4、取出步骤S3制得的壳聚糖复合止血材料,将快速止血药剂均匀喷于壳聚糖复合止血材料上,然后采用干燥箱在90℃下干燥2h,得止血海绵层;
S5:将步骤S4制得的止血海绵层粘贴在粘胶布中段,并在粘胶布和止血海绵垫层表面覆盖隔离纸,即得。
在步骤S2中所述壳聚糖的分子量为3000,壳聚糖/稀酸溶液中所用稀酸溶剂体积分数为3.5%,稀酸溶剂为醋酸;在步骤S3中洗涤剂为无水乙醇。
在步骤S4中快速止血药剂包括以下按照重量份的原料:葡萄糖水溶液18份、甘露糖15份、明胶6份、胶原蛋白12份、海藻酸钠18份、改性淀粉35份、交联剂7份。
所述的交联剂为京尼平。
实施例5
一种采用壳聚糖制作的止血海绵结构,所述止血海绵结构两侧表面设置止血海绵层,止血海绵层之间设置载药层,载药层和止血海绵层之间粘结;所述载药层内部填充物为止血中药粉末为槐花。
所述采用壳聚糖制作的止血海绵结构的制备方法,步骤如下:
S1、100ml稀酸溶解0.8g低分子量的壳聚糖,配成壳聚糖/稀酸溶液;
S2、将NH2-CNTs加入壳聚糖/稀酸溶液中,控制NH2-CNTs的质量百分含量为55%,超声分散20min,得到分散均匀的NH2-CNTs溶液;
S3、称取0.1g氧化再生纤维素,放入上述NH2-CNTs溶液中浸渍4h,浸渍结束后,用洗涤剂洗涤5次,最后将洗涤后的氧化再生纤维素-20℃预冻20h,预冻后放入冷冻干燥机中,在温度-33℃、真空度10Pa的条件下处理8h,得到壳聚糖复合止血材料;
S4、取出步骤S3制得的壳聚糖复合止血材料,将快速止血药剂均匀喷于壳聚糖复合止血材料上,然后采用干燥箱在70℃下干燥0.5h,得止血海绵层;
S5:将步骤S4制得的止血海绵层粘贴在粘胶布中段,并在粘胶布和止血海绵垫层表面覆盖隔离纸,即得。
在步骤S2中所述壳聚糖的分子量为500,壳聚糖/稀酸溶液中所用稀酸溶剂体积分数为1%,稀酸溶剂为醋酸;在步骤S3中洗涤剂为无水乙醇。
在步骤S4中快速止血药剂包括以下按照重量份的原料:葡萄糖水溶液17份、甘露糖11份、明胶5份、胶原蛋白10份、海藻酸钠14份、改性淀粉30份、交联剂5份。
所述的交联剂为戊二醛。
对比例1
与实施例5相比,所述配成的壳聚糖/稀酸溶液中不包含壳聚糖,其他与实施例5相同。
对比例2
与实施例5相比,所述快速止血药剂中不包含海藻酸钠,其他与实施例5相同。
对实施例5及对比例1-2所制备的止血海绵结构进行性能测试,测试结果如表1所示,比较对比例1和对比例2与实施例5得到的止血海绵结构的单位时间(24小时)中药释放情况可知,实施例5中止血中药开始释放量少,可持续释放更长时间。比较单位时间内凝血指数,实施例5的凝血效果更好。以上说明采用壳聚糖制作的止血海绵结构可减少突释,实现 缓释,增强肿瘤术后防复发效果,同时兼具止血功能。
表1 性能测试表
组别 | 实施例5 | 对比例1 | 对比例2 |
单位时间药物累积释放百分比/100% | 38 | 60 | 72 |
单位时间凝血指数/100% | 82 | 55 | 65 |
对于本领域技术人员而言,显然本发明不限于上述示范性实施例的细节,而且在不背离本发明的精神或基本特征的情况下,能够以其他的具体形式实现本发明。因此,无论从哪一点来看,均应将实施例看作是示范性的,而且是非限制性的,本发明的范围由所附权利要求而不是上述说明限定,因此旨在将落在权利要求的等同要件的含义和范围内的所有变化囊括在本发明内。
此外,应当理解,虽然本说明书按照实施方式加以描述,但并非每个实施方式仅包含一个独立的技术方案,说明书的这种叙述方式仅仅是为清楚起见,本领域技术人员应当将说明书作为一个整体,各实施例中的技术方案也可以经适当组合,形成本领域技术人员可以理解的其他实施方式。
Claims (8)
1.一种采用壳聚糖制作的止血海绵结构,其特征在于,所述止血海绵结构具有三层夹心结构,所述止血海绵结构两侧表面设置止血海绵层,止血海绵层之间设置载药层,载药层和止血海绵层之间粘结。
2.根据权利要求1所述的采用壳聚糖制作的止血海绵结构,其特征在于,所述载药层内部填充物为止血中药粉末为槐花、紫珠草或仙鹤草粉末中的一种或多种混合物。
3.一种如权利要求1-2任一所述的采用壳聚糖制作的止血海绵结构的制备方法,其特征在于,步骤如下:
S1、50-100ml稀酸溶解0.1-0.8g低分子量的壳聚糖,配成壳聚糖/稀酸溶液;
S2、将NH2-CNTs加入壳聚糖/稀酸溶液中,控制NH2-CNTs的质量百分含量为20-55%,超声分散20-35min,得到分散均匀的NH2-CNTs溶液;
S3、称取0.1-0.5g氧化再生纤维素,放入上述NH2-CNTs溶液中浸渍2-4h,浸渍结束后,用洗涤剂洗涤5-10次,最后将洗涤后的氧化再生纤维素-10℃--20℃预冻15-20h,预冻后放入冷冻干燥机中,在温度-46℃--10℃、真空度10-40Pa的条件下处理8-20h,得到壳聚糖复合止血材料;
S4、取出步骤S3制得的壳聚糖复合止血材料,将快速止血药剂均匀喷于壳聚糖复合止血材料上,然后采用干燥箱在70-90℃下干燥0.5-2h,得止血海绵层;
S5:将步骤S4制得的止血海绵层粘贴在粘胶布中段,并在粘胶布和止血海绵垫层表面覆盖隔离纸,即得。
4.根据权利要求3所述的采用壳聚糖制作的止血海绵结构的制备方法,其特征在于,在步骤S2中所述壳聚糖的分子量为500-5000,壳聚糖/稀酸溶液中所用稀酸溶剂体积分数为1-5%,稀酸溶剂为醋酸。
5.根据权利要求3所述的采用壳聚糖制作的止血海绵结构的制备方法,其特征在于,在步骤S3中洗涤剂为无水乙醇或丙酮中的一种。
6.根据权利要求3所述的采用壳聚糖制作的止血海绵结构的制备方法,其特征在于,在步骤S4中快速止血药剂包括以下按照重量份的原料:葡萄糖水溶液12-20份、甘露糖7-20份、明胶1-8份、胶原蛋白5-15份、海藻酸钠10-20份、改性淀粉20-40份、交联剂3-8份。
7.根据权利要求3所述的采用壳聚糖制作的止血海绵结构的制备方法,其特征在于,在步骤S4中快速止血药剂包括以下按照重量份的原料:葡萄糖水溶液15-18份、甘露糖9-15份、明胶3-6份、胶原蛋白8-12份、海藻酸钠12-18份、改性淀粉25-35份、交联剂4-7份。
8.根据权利要求6所述的采用壳聚糖制作的止血海绵结构的制备方法,其特征在于,所述的交联剂为戊二醛、甲醛、钙盐、京尼平或丹宁酸中的一种。
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