CN108553681A - 一种止血医用敷料及其制备方法 - Google Patents
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Abstract
本发明公开了一种止血医用敷料,是由以下重量份的原料制得的:聚谷氨酸‑普鲁兰多糖交联聚合物50份、燕麦蛋白20‑30份、鳕鱼皮胶原肽15‑25份、嗜碱性透明角质颗粒10‑20份、乙醇酸10‑20份、大蒜多糖5‑10份、透明质酸钠5‑15份。本发明还公开了该止血医用敷料的制备方法。本发明的止血医用敷料具有良好的生物相容性、生物可降解性、高效止血、抑菌、促进组织修复、预防黏连的优异性能,当与创面接触时,能快速吸收血液中水分,保持环境湿润,有效密闭出血创面。
Description
技术领域
本发明属于医用敷料领域,具体涉及一种止血医用敷料及其制备方法。
背景技术
血液是流动在心脏和血管内的不透明红色液体,主要成分为血浆、红细胞、白细胞和血小板。血浆约占血液的55%,是水、糖、脂肪、蛋白质、钾盐和钙盐的混合物。血细胞组成血液的另外45%。医学临床上指出,人体因急性出血而不采取有效的急救措施,则患者在6-20分钟内就会死亡。人体失血若超过全身血量的20%(成人约800cc)即发生休克;失血若超过全身血量的40%(成人约1600cc)即濒临死亡。据统计,创伤死亡人数占总死亡人数的10%,而其中大量出血造成死亡占其中的30%-40%,因此,早期控制出血是降低死亡率的主要方法。
创伤出血是危害人类健康和生命安全的重要病症之一,无论战争与和平时期,难以控制的大出血是引起伤员死亡的主要原因。目前传统敷料如医用脱脂棉纱布、棉垫和凡士林纱布等,是临床上皮肤创伤应用最广的敷料。传统敷料具有网状编织结构,其价格低廉、制作工艺相对简单、原料来源广泛、质地柔软,有较强的吸收能力,能防止创面渗液积聚,对创面愈合有一定程度的保护作用,至今仍在皮肤创伤中广泛应用。但是传统敷料也有很明显的缺点,比如不能保持创面湿润,延迟创面愈合;创面肉芽组织容易长入敷料的网眼中,更换敷料时易与创面伤口粘连,损伤新生的肉芽组织并引起疼痛;敷料渗透后屏障作用差,容易引起外源性感染,止血效果差。随着医学的飞速发展以及对药品安全要求的提高,高效的功能性敷料产品成为了研究热点。
发明内容
本发明提供了一种具有高效止血功能、抑菌、促进组织修复、预防黏连的止血医用敷料。
本发明还提供了该止血医用敷料的制备方法。
本发明的目的是通过如下技术方案实现的:
一种止血医用敷料,是由以下重量份的原料制得的:聚谷氨酸-普鲁兰多糖交联聚合物50份、燕麦蛋白20-30份、鳕鱼皮胶原肽15-25份、嗜碱性透明角质颗粒10-20份、乙醇酸10-20份、大蒜多糖5-10份、透明质酸钠5-15份。
所述的,聚谷氨酸-普鲁兰多糖交联聚合物是由以下方法制得的:将普鲁兰多糖溶液加至聚谷氨酸溶液中,25-35℃条件下搅拌反应1h,无水乙醇沉淀混合液,真空抽滤收集沉淀,将沉淀用去离子水溶解,置于透析袋中透析0.5-1.5h,将透析保留液冷冻干燥,得聚谷氨酸-普鲁兰多糖交联聚合物。
所述的,聚谷氨酸溶液和普鲁兰多糖溶液的质量比为1:1.5-2。
所述的,普鲁兰多糖溶液的浓度为5mg/ml,pH为3.5-4.5;所述聚谷氨酸溶液的浓度为80mg/ml,pH为4.0-5.0。
本发明所用聚谷氨酸分子量为40万,纯度为85%;普鲁兰多糖分子量为20万,纯度为94%。本发明所用透明质酸钠的分子量为1.0×104以下。
一种止血医用敷料的制备方法,是由以下步骤制得的:
1)纯化水加热至80-84℃,边搅拌边加入燕麦蛋白和透明质酸钠,80-84℃条件下使其溶解,自然冷却至室温,得浆料A;
2)将聚谷氨酸-普鲁兰多糖交联聚合物、鳕鱼皮胶原肽、嗜碱性透明角质颗粒、乙醇酸、大蒜多糖和浆料A混合均匀,80-90℃条件下共混0.5-1h,得共混液;
3)将共混液过滤、减压脱泡、静置后流延成膜,干燥,灭菌,得止血医用敷料。
所述的,纯化水的用量为燕麦蛋白重量的2-4倍。
所述的,干燥温度为50-90℃,干燥时间为6-15h。
所述的,灭菌为在γ射线下均匀照射8-12h。
本发明的有益效果:
1)本发明的止血医用敷料具有良好的生物相容性、生物可降解性、高效止血、抑菌、促进组织修复、预防黏连的优异性能,当与创面接触时,能快速吸收血液中水分,保持环境湿润,有效密闭出血创面。
2)本发明中聚谷氨酸-普鲁兰多糖交联聚合物具有极佳的生物相容性和生物可降解性,同时具有良好的抑菌性能,同时可促进血液快速凝固,起到凝血的作用。鳕鱼皮胶原肽能够有效地渗入角质层、真皮层,起到实现快速凝血,促进胶原合成的作用。燕麦蛋白和嗜碱性透明角质颗粒可以滋润皮肤,促进皮肤表皮的再生,促进创面愈合。乙醇酸由于分子中既有羟基又有羧基,兼有醇与酸的双重性,具有极好的抑菌作用,促进组织修复。本发明利用大蒜多糖具有一定抗凝血作用,起到防止止血期间的伤口与止血医用敷料粘连,或愈合期间伤口粘连的问题。透明质酸钠可促进表皮细胞的增殖和分化,增加血液循环,促进皮肤营养吸收作用从而加快皮肤愈合速度。
3)本发明的止血医用敷料的制备方法,采用发泡处理,不破坏各组分生物活性,形成多孔结构,使得本发明的止血医用敷料可实现快速止血,适合大面积推广和应用。
具体实施方式
下面结合具体实施例对本发明做进一步详细说明。
本发明所用聚谷氨酸分子量为40万,纯度为85%;普鲁兰多糖分子量为20万,纯度为94%。本发明所用透明质酸钠的分子量为1.0×104以下。
实施例1
一种止血医用敷料,是由以下重量份的原料制得的:聚谷氨酸-普鲁兰多糖交联聚合物50份、燕麦蛋白25份、鳕鱼皮胶原肽20份、嗜碱性透明角质颗粒15份、乙醇酸15份、大蒜多糖8份、透明质酸钠10份。
所述的,聚谷氨酸-普鲁兰多糖交联聚合物是由以下方法制得的:将普鲁兰多糖溶液加至聚谷氨酸溶液中,30℃条件下搅拌反应1h,无水乙醇沉淀混合液,真空抽滤收集沉淀,将沉淀用去离子水溶解,置于透析袋中透析1h,将透析保留液冷冻干燥,得聚谷氨酸-普鲁兰多糖交联聚合物。
所述的,聚谷氨酸溶液和普鲁兰多糖溶液的质量比为1:1.8。
所述的,普鲁兰多糖溶液的浓度为5mg/ml,pH为4;所述聚谷氨酸溶液的浓度为80mg/ml,pH为4.5。
一种止血医用敷料的制备方法,是由以下步骤制得的:
1)纯化水加热至82℃,边搅拌边加入燕麦蛋白和透明质酸钠,82℃条件下使其溶解,自然冷却至室温,得浆料A;
2)将聚谷氨酸-普鲁兰多糖交联聚合物、鳕鱼皮胶原肽、嗜碱性透明角质颗粒、乙醇酸、大蒜多糖和浆料A混合均匀,85℃条件下共混0.8h,得共混液;
3)将共混液过滤、减压脱泡、静置后流延成膜,干燥,灭菌,得止血医用敷料。
所述的,纯化水的用量为燕麦蛋白重量的4倍。
所述的,干燥温度为70℃,干燥时间为10h。
所述的,灭菌为在γ射线下均匀照射10h。
实施例2
一种止血医用敷料,是由以下重量份的原料制得的:聚谷氨酸-普鲁兰多糖交联聚合物50份、燕麦蛋白20份、鳕鱼皮胶原肽25份、嗜碱性透明角质颗粒10份、乙醇酸20份、大蒜多糖5份、透明质酸钠15份。
所述的,聚谷氨酸-普鲁兰多糖交联聚合物是由以下方法制得的:将普鲁兰多糖溶液加至聚谷氨酸溶液中,25℃条件下搅拌反应1h,无水乙醇沉淀混合液,真空抽滤收集沉淀,将沉淀用去离子水溶解,置于透析袋中透析1.5h,将透析保留液冷冻干燥,得聚谷氨酸-普鲁兰多糖交联聚合物。
所述的,聚谷氨酸溶液和普鲁兰多糖溶液的质量比为1:1.5。
所述的,普鲁兰多糖溶液的浓度为5mg/ml,pH为4.5;所述聚谷氨酸溶液的浓度为80mg/ml,pH为4.0。
一种止血医用敷料的制备方法,是由以下步骤制得的:
1)纯化水加热至80℃,边搅拌边加入燕麦蛋白和透明质酸钠,80℃条件下使其溶解,自然冷却至室温,得浆料A;
2)将聚谷氨酸-普鲁兰多糖交联聚合物、鳕鱼皮胶原肽、嗜碱性透明角质颗粒、乙醇酸、大蒜多糖和浆料A混合均匀,90℃条件下共混0.5h,得共混液;
3)将共混液过滤、减压脱泡、静置后流延成膜,干燥,灭菌,得止血医用敷料。
所述的,纯化水的用量为燕麦蛋白重量的3倍。
所述的,干燥温度为50℃,干燥时间为15h。
所述的,灭菌为在γ射线下均匀照射8h。
实施例3
一种止血医用敷料,是由以下重量份的原料制得的:聚谷氨酸-普鲁兰多糖交联聚合物50份、燕麦蛋白30份、鳕鱼皮胶原肽15份、嗜碱性透明角质颗粒20份、乙醇酸10份、大蒜多糖10份、透明质酸钠5份。
所述的,聚谷氨酸-普鲁兰多糖交联聚合物是由以下方法制得的:将普鲁兰多糖溶液加至聚谷氨酸溶液中,35℃条件下搅拌反应1h,无水乙醇沉淀混合液,真空抽滤收集沉淀,将沉淀用去离子水溶解,置于透析袋中透析0.5h,将透析保留液冷冻干燥,得聚谷氨酸-普鲁兰多糖交联聚合物。
所述的,聚谷氨酸溶液和普鲁兰多糖溶液的质量比为1:2。
所述的,普鲁兰多糖溶液的浓度为5mg/ml,pH为3.5;所述聚谷氨酸溶液的浓度为80mg/ml,pH为5.0。
一种止血医用敷料的制备方法,是由以下步骤制得的:
1)纯化水加热至84℃,边搅拌边加入燕麦蛋白和透明质酸钠,84℃条件下使其溶解,自然冷却至室温,得浆料A;
2)将聚谷氨酸-普鲁兰多糖交联聚合物、鳕鱼皮胶原肽、嗜碱性透明角质颗粒、乙醇酸、大蒜多糖和浆料A混合均匀,80℃条件下共混1h,得共混液;
3)将共混液过滤、减压脱泡、静置后流延成膜,干燥,灭菌,得止血医用敷料。
所述的,纯化水的用量为燕麦蛋白重量的2倍。
所述的,干燥温度为90℃,干燥时间为6h。
所述的,灭菌为在γ射线下均匀照射12h。
对比例1
一种止血医用敷料,是由以下重量份的原料制得的:聚谷氨酸-普鲁兰多糖交联聚合物50份、燕麦蛋白25份、鳕鱼皮胶原肽20份、嗜碱性透明角质颗粒15份、乙醇酸15份、透明质酸钠10份。
其余同实施例1。
对比例2
一种止血医用敷料,是由以下重量份的原料制得的:聚谷氨酸45份、普鲁兰多糖5份、燕麦蛋白25份、鳕鱼皮胶原肽20份、嗜碱性透明角质颗粒15份、乙醇酸15份、大蒜多糖8份、透明质酸钠10份。
其余同实施例1。
对比例3
一种止血医用敷料,是由以下重量份的原料制得的:聚谷氨酸-普鲁兰多糖交联聚合物50份、燕麦蛋白25份、鳕鱼皮胶原肽20份、嗜碱性透明角质颗粒15份、乙醇酸15份、大蒜多糖8份、透明质酸钠10份。
一种止血医用敷料的制备方法,是由以下步骤制得的:
1)纯化水加热至82℃,边搅拌边加入燕麦蛋白和透明质酸钠,82℃条件下使其溶解,自然冷却至室温,得浆料A;
2)将聚谷氨酸-普鲁兰多糖交联聚合物、鳕鱼皮胶原肽、嗜碱性透明角质颗粒、乙醇酸、大蒜多糖和浆料A混合均匀,置于-20℃的温度下下冷冻12h,再使用冷冻干燥机-40℃下冷冻12h,-60℃下抽真空24h,得止血医用敷料。
其余同实施例1。
血液量吸附试验
取10ml血液,置于50ml烧杯中,再分别取实施例1-3和对比例1-3制备的止血医用敷料,统一裁切出长×宽×高=1cm×1cm×0.5cm的长方体块状,常温下置于烧杯中进行血液吸附试验测试,并记录吸附全部血液所需的时间,无法全部吸附的记录最大吸附时间。试验结果如表1所示。
表1 血液量吸附试验结果
分组 | 是否全部吸附 | (全部/最大)吸附时间 |
实施例1 | 是 | 12s |
实施例2 | 是 | 14s |
实施例3 | 是 | 14s |
对比例1 | 是 | 19s |
对比例2 | 否 | 29s |
对比例3 | 否 | 22s |
由表1可知,实施例1-3和对比例1制备的止血医用敷料可达到全部吸附,而对比例2和3制备的止血医用敷料没有达到全部吸附,且对比例1-3的最大吸附时间明显高于实施例1-3的效果。说明同样体积的止血敷料中,本发明的止血医用敷料具有较大的吸附量。
快速止血试验
选取12只体重为6.0-6.3kg的比利时兔,随机分为6组,每组2只,分别标记为实施例1-3组和对比例1-3组,每只兔切断左耳耳缘静脉、右耳耳缘动脉以及左后肢股动脉的三分之二,自由出血5s,5s后分别用实施例1-3组和对比例1-3组的止血医用敷料压敷伤口。其中,各组实验所用的止血医用敷料均统一裁切成长×宽×高=5cm×5cm×2cm的长方体块状。试验结果如表2所示。
表2 快速止血试验结果
分组 | 左耳耳缘静脉平均止血时间(s) | 右耳耳缘动脉平均止血时间(s) | 左后肢股动脉平均止血时间(s) |
实施例1 | 21 | 23 | 99 |
实施例2 | 23 | 26 | 103 |
实施例3 | 21 | 26 | 106 |
对比例1 | 35 | 37 | 146 |
对比例2 | 40 | 52 | 175 |
对比例3 | 36 | 48 | 150 |
由表2可知,实施例1-3止血医用敷料的止血效果较好,特别是在测定流血量较大的左后肢股动脉的止血时间时,本发明的止血医用敷料具有较好的止血效果,可在较短时间内实现止血,其止血速度远远短于对比例1-3的止血医用敷料。
尽管本发明的实施方案已公开如上,但其并不仅仅限于说明书和实施方式中所列运用,它完全可以被适用于各种适合本发明的领域,对于熟悉本领域的人员而言,可容易地实现另外的修改,因此在不背离权利要求及等同范围所限定的一般概念下,本发明并不限于特定的细节。
Claims (8)
1.一种止血医用敷料,其特征在于,是由以下重量份的原料制得的:聚谷氨酸-普鲁兰多糖交联聚合物50份、燕麦蛋白20-30份、鳕鱼皮胶原肽15-25份、嗜碱性透明角质颗粒10-20份、乙醇酸10-20份、大蒜多糖5-10份、透明质酸钠5-15份。
2.根据权利要求1所述止血医用敷料,其特征在于,所述聚谷氨酸-普鲁兰多糖交联聚合物是由以下方法制得的:将普鲁兰多糖溶液加至聚谷氨酸溶液中,25-35℃条件下搅拌反应1h,无水乙醇沉淀混合液,真空抽滤收集沉淀,将沉淀用去离子水溶解,置于透析袋中透析0.5-1.5h,将透析保留液冷冻干燥,得聚谷氨酸-普鲁兰多糖交联聚合物。
3.根据权利要求2所述止血医用敷料,其特征在于,所述聚谷氨酸溶液和普鲁兰多糖溶液的质量比为1:1.5-2。
4.根据权利要求3所述止血医用敷料,其特征在于,所述普鲁兰多糖溶液的浓度为5mg/ml,pH为3.5-4.5;所述聚谷氨酸溶液的浓度为80mg/ml,pH为4.0-5.0。
5.一种权利要求1-4中任一项所述止血医用敷料的制备方法,其特征在于,是由以下步骤制得的:
1)纯化水加热至80-84℃,边搅拌边加入燕麦蛋白和透明质酸钠,80-84℃条件下使其溶解,自然冷却至室温,得浆料A;
2)将聚谷氨酸-普鲁兰多糖交联聚合物、鳕鱼皮胶原肽、嗜碱性透明角质颗粒、乙醇酸、大蒜多糖和浆料A混合均匀,80-90℃条件下共混0.5-1h,得共混液;
3)将共混液过滤、减压脱泡、静置后流延成膜,干燥,灭菌,得止血医用敷料。
6.根据权利要求5所述止血医用敷料的制备方法,其特征在于,所述纯化水的用量为燕麦蛋白重量的2-4倍。
7.根据权利要求5所述止血医用敷料的制备方法,其特征在于,所述干燥温度为50-90℃,干燥时间为6-15h。
8.根据权利要求5所述止血医用敷料的制备方法,其特征在于,所述灭菌为在γ射线下均匀照射8-12h。
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