CN105963757A - 一种自溶性止血复合材料及其制备方法 - Google Patents
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Abstract
一种自溶性止血复合材料及其制备方法，组分及各组分的质量份数如下：云南白药5~15份，壳聚糖10~30份，明矾2~5份、鱼肝油4~10份、氨基酸2~8份、乙酸5~10份、几丁糖1~3份、山梨酸6~12份、明胶4~12份、胶原蛋白3~6份、海藻酸钠4~10份、西米淀粉6~10份。自溶性止血复合材料能够为伤口提够有力的湿润恢复环境；生物相容性好，能够被机体逐渐吸收，在接触溶解酶等后，能够逐渐降解成单糖被人体吸收；在被用于人体体内时，不用取出，可减少病人的痛楚，减少对伤口的二次伤害，止血快，易吸收，使用方便。
Description
技术领域
本发明属于医用止血材料技术领域，具体涉及一种自溶性止血复合材料及其制备方法。
背景技术
日常生活中受伤在所难免，因而局部止血材料显得非常重要。如日常突发性事故的急救治疗,医院对病人的创伤止血中都常常要用到，特别是战争负伤的救护等。现有的止血纱布，止血纤维和止血绷带等止血材料在使用中都有一定的局限性：易与伤口粘连不容易换药,对感染和化脓伤口也无能为力。为减少因失血而造成的不必要的死亡，各国医学界对止血材料止血性能的要求更高了，开发出止血效果更佳的材料势在必行。做为止血敷料或止血剂的材料要具备良好的止血性能，优良的生物相容性，无毒副作用，无刺激性，易于加工成型等。因此，从现有的条件出发，寻找自然界中优良的生物材料并加以加工、改进就成为一种理想的选择。
随着外科技术快速发展，止血材料也得到了长足进步。例如奥地利林茨市HafsLund Nycomed 医药公司研制开发的Tachocomd可吸收创面止血封固剂，Gelfix止血材料以及Surgicel再生纤维素止血材料等。外科手术和动物实验都充分验证了其止血效果。同时，体外实验也论证了其优良的止血性能。赵宏霞等利用胶原蛋白和壳聚糖制备了复合膜，大大降低了止血海绵的成本且止血作用良好，也是一种较好的止血材料。石光生发明的止血炎痛停护膜气雾剂就是一种液态止血材料，采用含丙烷的液化丁烷做抛射剂，以洗必太做消毒杀菌剂，达克罗宁做表面局麻剂，乙酸乙酯做溶剂，乙醇做助溶剂，此外还加适量的二氧化碳，以聚甲基丙稀酸乙氧乙酯（或聚醋酸乙烯酯）做成膜剂等。此外，朱云等研制的新型硅凝胶烧伤创面汽雾剂，采用硅酮做成膜剂，三聚叔丁醇做助溶剂，另加抗菌止痛剂，抛射剂等制成。液状的止血材料经加工成可喷射的汽雾剂后使用方便，值得推广使用。上述止血材料例如传统的止血纱布，止血纤维和止血绷带易与伤口粘粘，不易更换，使用不便；而液体止血材料多含有各种有机溶剂，不安全环保。
发明内容
本发明的目的是要提供一种自溶性止血复合材料及其制备方法。
为了实现上述目的，本发明采用的技术方案为：
一种自溶性止血复合材料，组分及各组分的质量份数如下：云南白药 5~15份，壳聚糖10~30份，明矾2~5份、鱼肝油 4~10份、氨基酸 2~8份、乙酸5~10份、几丁糖 1~3份、山梨酸 6~12份、明胶 4~12份、胶原蛋白3~6份、海藻酸钠 4~10份、西米淀粉6~10份。
所述氨基酸为L-谷氨酸。
所述壳聚糖的脱乙酰度为60％～70％。
所述的一种自溶性止血复合材料，组分及各组分的质量份数如下：云南白药 8~12份，壳聚糖 15~25份，明矾3~4份、鱼肝油 6~8份、氨基酸 4~6份、乙酸6~8份、几丁糖 1~3份、山梨酸 8~10份、明胶 6~10份、胶原蛋白4~5份、海藻酸钠 6~8份、西米淀粉7~9份。
所述的一种自溶性止血复合材料，组分及各组分的质量份数如下：云南白药 10份，壳聚糖 20份，明矾3.5份、鱼肝油 7份、氨基酸 5份、乙酸7份、几丁糖 2份、山梨酸 9份、明胶 8份、胶原蛋白4.5份、海藻酸钠 7份、西米淀粉8份。
将壳聚糖、海藻酸钠溶于乙酸中，形成聚合物分散体系；然后加入余下组分，搅拌，干燥得自溶性止血复合材料。
所述干燥温度为60~80℃。
有益效果：
本发明提供的自溶性止血复合材料能够为伤口提够有力的湿润恢复环境；生物相容性好，能够被机体逐渐吸收，在接触溶解酶等后，能够逐渐降解成单糖被人体吸收；在被用于人体体内时，不用取出，可减少病人的痛楚，减少对伤口的二次伤害，止血快，易吸收，使用方便。
具体实施方式
以下实施例中采用的壳聚糖的脱乙酰度为60％～70％，相对分子量为105～106。实施例1
一种自溶性止血复合材料，组分及各组分的质量份数如下：云南白药 5份，壳聚糖 10份，明矾2份、鱼肝油 4份、氨基酸 2份、乙酸5份、几丁糖 1份、山梨酸 6份、明胶 4份、胶原蛋白3份、海藻酸钠 4份、西米淀粉6份。
将壳聚糖、海藻酸钠溶于乙酸中，形成聚合物分散体系；然后加入余下组分，搅拌，70℃干燥得自溶性止血复合材料。
实施例2
一种自溶性止血复合材料，组分及各组分的质量份数如下：云南白药15份，壳聚糖 30份，明矾5份、鱼肝油 10份、氨基酸 8份、乙酸10份、几丁糖 3份、山梨酸 12份、明胶 12份、胶原蛋白6份、海藻酸钠 10份、西米淀粉10份。
将壳聚糖、海藻酸钠溶于乙酸中，形成聚合物分散体系；然后加入余下组分，搅拌，70℃干燥得自溶性止血复合材料。
实施例3
一种自溶性止血复合材料，组分及各组分的质量份数如下：云南白药 8份，壳聚糖 15份，明矾3份、鱼肝油 6份、氨基酸 4份、乙酸6份、几丁糖 1份、山梨酸 8份、明胶 6份、胶原蛋白4份、海藻酸钠 6份、西米淀粉7份。
将壳聚糖、海藻酸钠溶于乙酸中，形成聚合物分散体系；然后加入余下组分，搅拌，70℃干燥得自溶性止血复合材料。
实施例4
一种自溶性止血复合材料，组分及各组分的质量份数如下：云南白药 12份，壳聚糖 25份，明矾4份、鱼肝油 8份、氨基酸 6份、乙酸8份、几丁糖 3份、山梨酸 10份、明胶 10份、胶原蛋白5份、海藻酸钠 8份、西米淀粉9份。
将壳聚糖、海藻酸钠溶于乙酸中，形成聚合物分散体系；然后加入余下组分，搅拌，70℃干燥得自溶性止血复合材料。
实施例5
一种自溶性止血复合材料，组分及各组分的质量份数如下：云南白药 10份，壳聚糖 20份，明矾3.5份、鱼肝油 7份、氨基酸 5份、乙酸7份、几丁糖 2份、山梨酸 9份、明胶 8份、胶原蛋白4.5份、海藻酸钠 7份、西米淀粉8份。
将壳聚糖、海藻酸钠溶于乙酸中，形成聚合物分散体系；然后加入余下组分，搅拌，70℃干燥得自溶性止血复合材料。
对比例1
一种自溶性止血复合材料，组分及各组分的质量份数如下：壳聚糖 20份，明矾3.5份、鱼肝油 7份、氨基酸 5份、乙酸7份、几丁糖 2份、山梨酸 9份、明胶 8份、胶原蛋白4.5份、海藻酸钠 7份。（与实施例5相比较，不含有云南白药和西米淀粉）
将壳聚糖、海藻酸钠溶于乙酸中，形成聚合物分散体系；然后加入余下组分，搅拌，70℃干燥得自溶性止血复合材料。
对比例2
一种自溶性止血复合材料，组分及各组分的质量份数如下：云南白药 10份，壳聚糖 20份，明矾3.5份、鱼肝油 7份、氨基酸 5份、乙酸7份、山梨酸 9份、明胶 8份、西米淀粉8份。（与实施例5相比较，不包含胶原蛋白、海藻酸钠、几丁糖）
将壳聚糖溶于乙酸中，形成聚合物分散体系；然后加入余下组分，搅拌，70℃干燥得自溶性止血复合材料。
对实施例1~5以及对比例1~2制备得到的自溶性止血复合材料进行相容性实验和凝血实验，实验方法如下：
血小板黏附试验
血小板粘附试验是判断生物材料血液相容性的一项重要指标。本实验采取玻球法对各组比例膜的血小板粘附进行了考察。结果如表1所示。根据国家对生物材料的有关规定，材料的血小板消耗率低于40%时能与血液相接触使用。本实验制得的各组膜相对于空白组的血小板消耗率大大低于这一标准，具有较好的血液相容性。
表1
| 实施例 | 1 | 2 | 3 | 4 | 5 | 对比1 | 对比2 |
| 血小板消耗率/% | 17.5% | 16.3% | 11.0% | 9.4% | 5.1% | 31.8% | 29.5% |
动态凝血实验
动态凝血实验（即材料的抗凝血性能）主要是检测内源性凝血因子被激活的程度的情况。研究表明，材料的抗凝血参数 BCI 的数值可直接反应材料的抗凝特性。在确定的时间内，BCI 的数值越大，材料的抗凝血性能越好。实施例1-5的动态凝血实验结果如表2所示，从表中可以看出随着接触时间的延长，材料的 BCI 值呈现降低的趋势，
表2：
| 实施例1 | 实施例2 | 实施例3 | 实施例4 | 实施例5 | |
| 5min | 63.2 | 68.1 | 77.5 | 73.5 | 81.9 |
| 10min | 48.3 | 55.9 | 66.1 | 60.7 | 76.4 |
| 20min | 35.4 | 37.1 | 48.6 | 42.4 | 68.8 |
| 30min | 21.5 | 25.3 | 30.3 | 31.3 | 541 |
溶血试验
溶血实验是检测生物材料与血液中的红细胞相互作用，以评价其对红细胞的影响的一项至关重要的指标。材料的溶血性越高，表明其对血细胞的破坏程度也就越大。实施例1-5的溶血试验结果见表3，其溶血率都低于 5%，符合生物材料溶血实验的要求，具有较好的血液相容性。
表3：
| 实施例 | 1 | 2 | 3 | 4 | 5 | 对比1 | 对比2 |
| 溶血度/% | 3.7% | 3.8% | 3.5% | 2.1% | 1.6% | 4.8% | 5.3% |
从表1-3中可以看出，本发明自溶性止血复合材料具有优异的血液相容性，止血快。
Claims (7)
1.一种自溶性止血复合材料，其特征在于组分及各组分的质量份数如下：云南白药 5~15份，壳聚糖 10~30份，明矾2~5份、鱼肝油 4~10份、氨基酸 2~8份、乙酸5~10份、几丁糖 1~3份、山梨酸 6~12份、明胶 4~12份、胶原蛋白3~6份、海藻酸钠 4~10份、西米淀粉6~10份。
2.根据权利要求1所述的一种自溶性止血复合材料，其特征在于：所述氨基酸为L-谷氨酸。
3.根据权利要求1所述的一种自溶性止血复合材料，其特征在于：所述壳聚糖的脱乙酰度为60％～70％。
4.根据权利要求1所述的一种自溶性止血复合材料，其特征在于：组分及各组分的质量份数如下：云南白药 8~12份，壳聚糖 15~25份，明矾3~4份、鱼肝油 6~8份、氨基酸 4~6份、乙酸6~8份、几丁糖 1~3份、山梨酸 8~10份、明胶 6~10份、胶原蛋白4~5份、海藻酸钠 6~8份、西米淀粉7~9份。
5.根据权利要求1所述的一种自溶性止血复合材料，其特征在于：组分及各组分的质量份数如下：云南白药 10份，壳聚糖 20份，明矾3.5份、鱼肝油 7份、氨基酸 5份、乙酸7份、几丁糖 2份、山梨酸 9份、明胶 8份、胶原蛋白4.5份、海藻酸钠 7份、西米淀粉8份。
6.权利要求1所述的一种自溶性止血复合材料的制备方法，其特征在于：将壳聚糖、海藻酸钠溶于乙酸中，形成聚合物分散体系；然后加入余下组分，搅拌，干燥得自溶性止血复合材料。
7.根据权利要求6所述的一种自溶性止血复合材料的制备方法，其特征在于：所述干燥温度为60~80℃。
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