CN108939140A - 一种用于止血的组合物及医用止血敷料 - Google Patents
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Abstract
本发明公开了一种用于止血的组合物及医用止血敷料,该组合物包括以下重量份数的原料:胶原蛋白10~20份、角蛋白8~15份、壳聚糖30~40份、凝胶基质3~8份、纳米锌粉15~20份、墨鱼骨粉8~15份、海藻酸盐15~25份和止血中草药提取物10~20份。本发明利用胶原蛋白、角蛋白、壳聚糖、纳米锌粉、墨鱼骨粉、海藻酸盐和止血中草药提取物等成分的作用优势和相互协同作用,使制备得到的医用止血敷料,具有止血速度快、止血效果好,且防黏连,能够有效的杀菌抑菌及生物相容性好等优点,同时本发明的用于止血的组合物及医用止血敷料对人体无杜副作用,对皮肤无任何刺激,使用安全。
Description
技术领域
本发明涉及生物医学材料技术领域,具体而言,涉及一种用于止血的组合物及医用止血敷料。
背景技术
通常,在人体血液自身凝血机能正常的情况下,一般性的组织创伤可以自我修复,表皮出血或静脉出血都可以自凝。然而,动脉出血、较大静脉出血、较严重的组织创伤或大多数的外科手术操作时血液无法及时自凝并达到自我防护的机,如不及时采取措施,就会导致严重的出血,失血过量往往会危及生命。尤其是在战场上、野外突发事故、地震类自然灾害、外科手术等各种情况下,使用快速、有效的止血材料尤为重要。
然而,传统的止血材料如止血带功能和效果单一,抗菌效果差,止血效果欠佳,止血速度慢。
发明内容
有鉴于此,本发明提供的一种用于止血的组合物及医用止血敷料,更好的克服了上述现有技术存在的问题和缺陷,利用胶原蛋白、角蛋白、壳聚糖、纳米锌粉、墨鱼骨粉、海藻酸盐和止血中草药提取物等成分的作用优势和相互协同作用,使制备得到的医用止血敷料,具有止血速度快、止血效果好,且防黏连,能够有效的杀菌抑菌及生物相容性好等优点,同时本发明的用于止血的组合物及医用止血敷料对人体无杜副作用,对皮肤无任何刺激,使用安全。
一种用于止血的组合物,包括以下重量份数的原料:胶原蛋白10~20份、角蛋白8~15份、壳聚糖30~40份、凝胶基质3~8份、纳米锌粉15~20份、墨鱼骨粉8~15份、海藻酸盐15~25份和止血中草药提取物10~20份。
进一步地,所述组合物还包括以下重量份数的原料:远红外纳米粉1~5份。
进一步地,所述组合物还包括以下重量份数的原料:磁粉3~8份。
进一步地,所述壳聚糖为水溶性壳聚糖,所述壳聚糖的分子量为5000~100000道尔顿。
进一步地,所述海藻酸盐为海藻酸钙;所述凝胶基质为聚乙烯醇。
进一步地,所述止血中药提取物为艾叶提取物、三七提取物和白芨提取物中的一种或几种的混合物。
本发明还提供了一种医用止血敷料,所述医用止血敷料包括如下制备步骤:
将上述的组合物加入水中分散均匀得到混合液;
将基材浸泡在所述混合液中,然后干燥得到。
进一步地,所述基材为无纺布、纱布或棉片。
进一步地,所述干燥过程为真空冷冻干燥。
进一步地,所述水的用量为所述组合物的总重量的1.5~3倍,所述水为去离子水。
与现有技术相比,本发明的用于止血的组合物及医用止血敷料的有益效果是:
本发明充分利用胶原蛋白、角蛋白、壳聚糖、纳米锌粉、墨鱼骨粉、海藻酸盐和止血中草药提取物等成分的作用优势和相互协同作用,使制备得到的医用止血敷料,具有止血速度快、止血效果好,且防黏连,能够有效的杀菌抑菌及生物相容性好等优点,同时本发明的用于止血的组合物及医用止血敷料对人体无杜副作用,对皮肤无任何刺激,使用安全。
为使本发明的上述目的、特征和优点能更明显易懂,下文特举较佳实施例,作详细说明如下。
具体实施方式
为了便于理解本发明,下面结合实施例的方式对本发明的技术方案做详细说明,在下面的描述中阐述了很多具体细节以便于充分理解本发明。
但是本发明能够以很多不同于在此描述的其它方式来实施,本领域技术人员可以在不违背本发明内涵的情况下做类似改进,因此本发明不受下面公开的具体实施的限制。
除非另有限定,本文使用的所有技术以及科学术语具有与本发明所属领域普通技术人员通常理解的相同的含义。当存在矛盾时,以本说明书中的定义为准。
如本文所用之术语:
“由……制备”与“包含”同义。本文中所用的术语“包含”、“包括”、“具有”、“含有”或其任何其它变形,意在覆盖非排它性的包括。例如,包含所列要素的组合物、步骤、方法、制品或装置不必仅限于那些要素,而是可以包括未明确列出的其它要素或此种组合物、步骤、方法、制品或装置所固有的要素。
连接词“由……组成”排除任何未指出的要素、步骤或组分。如果用于权利要求中,此短语将使权利要求为封闭式,使其不包含除那些描述的材料以外的材料,但与其相关的常规杂质除外。当短语“由……组成”出现在权利要求主体的子句中而不是紧接在主题之后时,其仅限定在该子句中描述的要素;其它要素并不被排除在作为整体的所述权利要求之外。
当量、浓度、或者其它值或参数以范围、优选范围、或一系列上限优选值和下限优选值限定的范围表示时,这应当被理解为具体公开了由任何范围上限或优选值与任何范围下限或优选值的任一配对所形成的所有范围,而不论该范围是否单独公开了。例如,当公开了范围“1~5”时,所描述的范围应被解释为包括范围“1~4”、“1~3”、“1~2”、“1~2和4~5”、“1~3和5”等。当数值范围在本文中被描述时,除非另外说明,否则该范围意图包括其端值和在该范围内的所有整数和分数。
“和/或”用于表示所说明的情况的一者或两者均可能发生,例如,A和/或B包括(A和B)和(A或B)。
一种用于止血的组合物,包括以下重量份数的原料:
胶原蛋白10~20份如10份、12份、15份、18份或20份等;
角蛋白8~15份如8份、9份、10份、11份、12份、13份、14份或15份等;
壳聚糖30~40份如30份、32份、35份、38份或40份等;
凝胶基质3~8份如3份、4份、5份、6份、7份或8份等;
纳米锌粉15~20份如15份、16份、17份、18份、19份或20份等;
墨鱼骨粉8~15份如8份、9份、10份、11份、12份、13份、14份或15份等;
海藻酸盐15~25份如15份、18份、20份、23份或25份等;
止血中草药提取物如10份、12份、15份、18份或20份等。
需要说明的是,胶原蛋白是一种生物高分子材料,也是生物体内含量最多、分布最广的功能性蛋白,其具有低免疫原性、良好的生物相容性、生物可降解性和凝血性,其可快速与血液中的血红蛋白结合,形成止血凝块,可机械物理地封堵毛细血管渗血,另外,胶原蛋白与伤口紧密结合后,可渗入新生组织当中,并作为细胞生长时之支架。
优选地,所述胶原蛋白可为鱼胶原蛋白。鱼胶原蛋白(多肽)主要是从罗非鱼、鳕鱼新鲜皮、鱼鳞中通过生物酶定向剪切技术提取,主要为I型胶原蛋白,产品富含19种氨基酸,分子量在2000~5000D长度之间,具有很高的消化吸收性,本产品在水溶液中的热稳定性极好,与人体皮肤有极好的亲和性,能够很好的发挥其渗透和修复等功能。
当然,本发明实施例并不限制胶原蛋白的种类,其也可为陆生动物胶原蛋白,但鱼胶原蛋白较陆生动物胶原蛋白安全性及凝血效果更好。
角蛋白是一种具有结缔和保护功能的纤维状蛋白质,其含有较多的胱氨酸。
壳聚糖是由自然界广泛存在的几丁质经过脱乙酰作用得到的,化学名称为聚葡萄糖胺(1-4)-2-氨基-β-D-葡萄糖,具有优良的生物官能性、血液相容性、安全性和微生物降解性等。壳聚糖可促进纤维细胞的迁移,对基质细胞有趋化、迁移和激活作用,并加速细胞增殖和组织重塑,促进皮肤组织修复。壳聚糖的降解产物N-乙酰葡糖胺(NAG)对组织的疤痕修复非常重要。壳聚糖本身还具有止血作用,其通过与红细胞之间的相互作用,主要是对红细胞的凝集作用而实现止血。其止血机理是:带正电荷的壳聚糖与细胞表面带负电荷的神经氨酸残基的受体发生相互作用,促进血小板的聚集,激活凝血系统。而且壳聚糖具有明显的膜形成作用,可以加速伤口愈合。
优选地,所述壳聚糖为水溶性壳聚糖,所述壳聚糖的分子量为5000~100000道尔顿。
优选地,所述凝胶基质为聚乙烯醇。但是,本发明并不限制凝胶基质的种类,所述凝胶基质还可为卡波姆或纤维素衍生物如羟丙甲纤维素等。
纳米锌粉具有抗菌、强效杀菌、渗透性强、修复再生、抗菌持久、平安无毒、无耐药性的特性和功效。
墨鱼骨粉具有制酸止痛、止血、骨缺损修复、抗辐射、抗肿瘤、抗溃疡等作用。墨鱼骨粉为天然的生物活性碳酸钙,具有天然的多孔结构,能与壳聚糖、胶原蛋白、透明质酸等相吸附,控制降解速度,止血、消炎效果好,能加强防粘连作用和止血功能,促进创面愈合;同时墨鱼骨粉为天然材料,组织相容性好,也易于降解,且墨鱼骨粉降解后能大量释放活性钙离子,促进组织修复。
优选地,所述海藻酸盐为海藻酸钙,当然所述海藻酸盐还可以为海藻酸钠。
海藻酸钙为白色至浅黄棕色纤维状粉末或粗粉,无臭无味,不溶于水,具有良好的生物降解性和生物相容性。海藻酸钙具有吸附细菌,阻挡细菌通过的屏障作用,同时通过钙离子释放到伤口,产生表面凝胶,诱导血小板活化,激活伤口巨噬细胞增强创面抗御致病微生物,起到止血、加速愈合和防止疤痕形成的作用。
优选地,所述止血中药提取物为艾叶提取物、三七提取物和白芨提取物中的一种或几种的混合物。
艾叶又称艾草、冰台、艾蒿、医草、灸草、蕲艾、黄草、家艾等;其味苦、微温、无毒,苦燥辛散,能理气血、温经脉、逐寒湿、止冷痛。艾叶提取物具有散寒止痛、温经止血等功效。
三七,又名田七、血参、血山草等,味甘、微苦、性温。三七提取物具有化瘀止血、活血定痛的功效。
白芨,又名连及草、甘根、朱兰等,味辛、苦、甘、涩。白芨能增强血小板第三因子活性,显著缩短凝血时间及凝血酶原形成时间,抑制纤维蛋白溶酶活性,对局部出血有止血作用,其还具有抗真菌作用,白及所含有的3个联苯类和2个双氢菲类化合物对金黄色葡萄球菌、枯草杆菌、白色念珠菌ATCC1057及发癣菌QM248有抑制作用。白芨提取物具有收敛止血、消肿生肌的功效。且白芨中含有胶状成分,能够在创面形成一种保护膜。
优选地,所述艾叶提取物、所述三七提取物和所述白芨提取物均为去离子水提取物,即将艾叶、三七和白芨采用现有的水提取浓缩技术得到。优选地,所述艾叶提取物为:将艾叶与去离子水按1:5~8的质量比混合,然后经煎煮过滤后,再浓缩提取得到。所述三七提取物为:将三七与去离子水按1:10~15的质量比混合,然后经煎煮过滤后,再浓缩提取得到。所述白芨提取物为:将白芨与去离子水按1:6~11的质量比混合,然后经煎煮过滤后,再浓缩提取得到。
需要说明的是,几种的混合物为艾叶、三七和白芨的至少两种按任意比例的混合物。
本发明充分利用胶原蛋白、壳聚糖、纳米银粉和止血中草药提取物等成分的作用优势和相互协同作用,使制备得到的医用止血敷料,具有止血速度快、止血效果好、能够有效的抗菌抑菌及生物相容性好等优点,同时本发明的用于止血的组合物及医用止血敷料对人体无杜副作用,对皮肤无任何刺激,使用安全。
优选地,所述组合物还包括以下重量份数的原料:远红外纳米粉1~5份。
优选地,所述组合物还包括以下重量份数的原料:磁粉3~8份。
远红外纳米粉是用特殊纳米复合技术精制而成的新型纳米复合远红外保健功能材料。纳米复合无机远红外保健材料具有与人体辐射吸收相应波长的高远红外辐射率,是良好的人体保健用远红外辐射材料,具有抗紫外线、杀菌消除异味、防病治病等功能,可以有效地改善人体微循环,促使正常微循环血流增加2~3倍,提高组织供氧,改善新陈代谢,增强免疫力。
另外,远红外纳米粉可令水分子活性化,提高身体的含氧量。人体约70%是水分,血液的水分比更高过80%,若血气不足,血液中的水分子便集结成惰性水(即四个氢分子和一个氧分子结合),不能通过细胞膜;远红外线能使水分子产生共振并细化,变成独立水分子(即两个氢分子和一个氧分子结合),提高身体的含氧量,细胞因而能恢复活力,精神更畅旺、头脑更灵活、进而能提高抗病能力,延缓衰老。
优选地,所述远红外纳米粉可为纳米陶瓷粉。
磁粉产生的磁场具有活络血液、增进血液含氧量,提高免疫力的作用。所述磁粉可列举为稀土永磁材料,稀土永磁材料是指稀土金属和过渡族金属形成的合金经一定的工艺制成的永磁材料,分钐钴(SmCo)永磁体和钕铁硼(NdFeB)永磁体。稀土永磁材料具有强磁能量场。利用强磁场刺激人体经络穴位,可以起到疏通经络、调节神经、促进气血运行的作用;强磁场也可以促进机体的血液循环,加强新陈代谢,起到良好的消炎消肿、镇痛安神及促进睡眠的作用。
本发明还提供了一种医用止血敷料,所述医用止血敷料包括如下制备步骤:
(1)将上述的组合物加入水中分散均匀得到分散液,优选地,所述分散方式采用超声分散,超声功率优选为400~800W。当然,所述分散方式还可为搅拌分散或振荡分散。
优选地,所述水的用量为所述组合物的总重量的2~3倍如1.5倍、1.8倍、2.0倍、2.3倍或2.5倍等。
优选地,所述水为去离子水。当然,所述水还可以为蒸馏水。
(2)将基材浸泡在所述分散液中,然后干燥得到。
优选地,所述基材为无纺布、纱布或棉片。所述无纺布可为竹炭纤维无纺布。
竹炭纤维具有良好的吸湿干燥、抗菌除异味的功效,对人体零刺激且无负作用。需要说明的是,竹炭纤维呈内外贯穿的蜂窝状微孔结构,该结构非常利于胶原蛋白、纳米银粉、止血中草药提取物等功能性材料的植入。
所述无纺布还可以为植物纤维水刺无纺布。
优选地,所述干燥过程为真空冷冻干燥。
更优地,所述干燥过程为在-15~10℃下真空冷冻干燥18~24h。
为了便于理解本发明,下面结合实施例来进一步说明本发明的技术方案。申请人声明,本发明通过以下实施例来说明本发明的详细工艺设备和工艺流程,但本发明并不局限于下述详细工艺设备和工艺流程,即不意味着本发明应依赖上述详细工艺设备和工艺流程才能实施。所属技术领域的技术人员应该明了,对本发明的任何改进,对本发明产品各原料的等效替换及辅助成分的添加、具体方式的选择等,均落在本发明的保护范围和公开范围之内。
实施例1
一种医用止血敷料的具体制备步骤如下:
(1)称取10份胶原蛋白、8份角蛋白、30份壳聚糖、3份聚乙烯醇、15份纳米锌粉、15份墨鱼骨粉、25份海藻酸钙、6份艾叶提取物和4份白芨提取物,备用。
(2)将步骤(1)中各原料混合均匀后,加入232份水中,在400W的超声功率下超声分散2.5h,得到分散液。
(3)将竹炭纤维无纺布浸渍在步骤(2)制备的分散液中6h,取出浸渍后的竹炭纤维无纺布,在温度为-10℃的真空冷冻干燥机中冷冻干燥24h,即得医用止血敷料。
实施例2
一种医用止血敷料的具体制备步骤如下:
(1)称取15份胶原蛋白、10份角蛋白、35份壳聚糖、5份聚乙烯醇、18份纳米锌粉、12份墨鱼骨粉、20份海藻酸钙、7份艾叶提取物和8份白芨提取物,备用。
(2)将步骤(1)中各原料混合均匀后,加入250份水中,在600W的超声功率下超声分散2h,得到分散液。
(3)将竹炭纤维无纺布浸渍在步骤(2)制备的分散液中8h,取出浸渍后的竹炭纤维无纺布,在温度为-15℃的真空冷冻干燥机中冷冻干燥20h,得到医用止血敷料。
实施例3
一种医用止血敷料的具体制备步骤如下:
(1)称取20份胶原蛋白、15份角蛋白、40份壳聚糖、8份聚乙烯醇、20份纳米锌粉、8份墨鱼骨粉、15份海藻酸钙、10份艾叶提取物和10份白芨提取物,备用。
(2)将步骤(1)中各原料混合均匀后,加入300份水中,在800W的超声功率下超声分散2h,得到分散液。
(3)将竹炭纤维无纺布浸渍在步骤(2)制备的分散液中10h,取出浸渍后的竹炭纤维无纺布,在温度为-10℃的真空冷冻干燥机中冷冻干燥22h,得到医用止血敷料。
实施例4
一种医用止血敷料的具体制备步骤如下:
(1)称取12份胶原蛋白、9份角蛋白、32份壳聚糖、4份聚乙烯醇、16份纳米锌粉、13份墨鱼骨粉、19份海藻酸钙、4份远红外纳米粉、4份磁粉、5份艾叶提取物、4份三七提取物和3份白芨提取物,备用。
(2)将步骤(1)中各原料混合均匀后,加入290份水中,在500W的超声功率下超声分散2.5h,得到分散液。
(3)将竹炭纤维无纺布浸渍在步骤(2)制备的分散液中10h,取出浸渍后的竹炭纤维无纺布,在温度为-15℃的真空冷冻干燥机中冷冻干燥18h,得到医用止血敷料。
实施例5
一种医用止血敷料的具体制备步骤如下:
(1)称取13份胶原蛋白、12份角蛋白、33份壳聚糖、6份聚乙烯醇、17份纳米锌粉、13份墨鱼骨粉、22份海藻酸钙、3份远红外纳米粉、6份磁粉、4份艾叶提取物、5份三七提取物和3份白芨提取物,备用。
(2)将步骤(1)中各原料混合均匀后,加入260份水中,在600W的超声功率下超声分散2h,得到分散液。
(3)将竹炭纤维无纺布浸渍在步骤(2)制备的分散液中8h,取出浸渍后的竹炭纤维无纺布,在温度为-10℃的真空冷冻干燥机中冷冻干燥24h,得到医用止血敷料。
实施例6
一种医用止血敷料的具体制备步骤如下:
(1)称取16份胶原蛋白、11份角蛋白、38份壳聚糖、6份聚乙烯醇、16份纳米锌粉、10份墨鱼骨粉、18份海藻酸钙、2份远红外纳米粉、7份磁粉、5份艾叶提取物、5份三七提取物和3份白芨提取物,备用。
(2)将步骤(1)中各原料混合均匀后,加入270份水中,在400W的超声功率下超声分散3h,得到分散液。
(3)将竹炭纤维无纺布浸渍在步骤(2)制备的分散液中6h,取出浸渍后的竹炭纤维无纺布,在温度为-10℃的真空冷冻干燥机中冷冻干燥20h,得到医用止血敷料。
实施例7
一种医用止血敷料的具体制备步骤如下:
(1)称取19份胶原蛋白、14份角蛋白、35份壳聚糖、7份聚乙烯醇、19份纳米锌粉、9份墨鱼骨粉、15份海藻酸钙、2份远红外纳米粉、6份磁粉、4份艾叶提取物、6份三七提取物和6份白芨提取物,备用。
(2)将步骤(1)中各原料混合均匀后,加入250份水中,在500W的超声功率下超声分散2.5h,得到分散液。
(3)将竹炭纤维无纺布浸渍在步骤(2)制备的分散液中10h,取出浸渍后的竹炭纤维无纺布,在温度为-10℃的真空冷冻干燥机中冷冻干燥22h,得到医用止血敷料。
实施例8
一种医用止血敷料的具体制备步骤如下:
(1)称取20份胶原蛋白、15份角蛋白、40份壳聚糖、8份聚乙烯醇、20份纳米锌粉、8份墨鱼骨粉、15份海藻酸钙、1份远红外纳米粉、8份磁粉、3份艾叶提取物、3份三七提取物和5份白芨提取物,备用。
(2)将步骤(1)中各原料混合均匀后,加入280份水中,在600W的超声功率下超声分散2.5h,得到分散液。
(3)将竹炭纤维无纺布浸渍在步骤(2)制备的分散液中8h,取出浸渍后的竹炭纤维无纺布,在温度为-10℃的真空冷冻干燥机中冷冻干燥24h,得到医用止血敷料。
对比例1
本对比例与实施例2的区别在于不添加艾叶提取物和白芨提取物。
对比例2
本对比例与实施例2的区别在于不添加胶原蛋白。
对比例3
本对比例与实施例2的区别在于不添加角蛋白和墨鱼骨粉。
对比例4
本对比例与实施例2的区别在于不添加海藻酸钠。
对比例3
本对比例与实施例2的区别在于不添加纳米银。
对本发明实施例1~8及对比例1~3所得的医用止血敷料进行止血时间、拉伸强度、生物相容性和金黄色葡萄球菌抑菌率性能测试,结果如表1所示:
表1
由上述表1结果可知,本发明实施例1~8的医疗止血材料较对比例1~4的医疗止血材料的止血时间更快,金黄色葡萄球菌抑菌率更高。
上述仅为本发明的优选实施例而已,并不用于限制本发明,对于本领域的技术人员来说,本发明配方及制备工艺可以有各种更改和变化。凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。
Claims (10)
1.一种用于止血的组合物,其特征在于:包括以下重量份数的原料:胶原蛋白10~20份、角蛋白8~15份、壳聚糖30~40份、凝胶基质3~8份、纳米锌粉15~20份、墨鱼骨粉8~15份、海藻酸盐15~25份和止血中草药提取物10~20份。
2.根据权利要求1所述的用于止血的组合物,其特征在于:还包括以下重量份数的原料:远红外纳米粉1~5份。
3.根据权利要求1所述的用于止血的组合物,其特征在于:还包括以下重量份数的原料:磁粉3~8份。
4.根据权利要求1所述的用于止血的组合物,其特征在于:所述壳聚糖为水溶性壳聚糖,所述壳聚糖的分子量为5000~100000道尔顿。
5.根据权利要求1所述的用于止血的组合物,其特征在于:所述海藻酸盐为海藻酸钙;所述凝胶基质为聚乙烯醇。
6.根据权利要求1所述的用于止血的组合物,其特征在于:所述止血中药提取物为艾叶提取物、三七提取物和白芨提取物中的一种或几种的混合物。
7.一种医用止血敷料,其特征在于:所述医用止血敷料包括如下制备步骤:
将权利要求1-6任一项所述的组合物加入水中分散均匀得到混合液;
将基材浸泡在所述混合液中,然后干燥得到。
8.根据权利要求7所述的医用止血敷料,其特征在于:所述基材为无纺布、纱布或棉片。
9.根据权利要求7所述的医用止血敷料,其特征在于:所述干燥过程为真空冷冻干燥。
10.根据权利要求7所述的医用止血敷料,其特征在于:所述水的用量为所述组合物的总重量的1.5~3倍,所述水为去离子水。
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