CN107296954A - 一种层粘连蛋白创面保护膜 - Google Patents
一种层粘连蛋白创面保护膜 Download PDFInfo
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- CN107296954A CN107296954A CN201710429812.1A CN201710429812A CN107296954A CN 107296954 A CN107296954 A CN 107296954A CN 201710429812 A CN201710429812 A CN 201710429812A CN 107296954 A CN107296954 A CN 107296954A
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- laminin
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Abstract
一种层粘连蛋白创面保护膜是以动物血浆层粘连蛋白为主要成分，加有无菌生理盐水以及药用辅料组成。其具体成分重量份配比为：动物血浆层粘连蛋白微囊1‑30份，成膜基质0.1‑30份，保湿剂1‑10份，无菌生理盐水补足至100份。所述的动物血浆层粘连蛋白微囊是以溶于水的层粘连蛋白溶液为囊心物，由囊材包裹的微囊；所述的成膜基质为聚乙烯醇、卡波姆、海藻酸钠、海藻酸钙中的一种或几种。本发明将层粘连蛋白制成微囊，可维持其生物活性的同时，延长保存期。本发明可制成水剂或凝胶剂型，制备工艺简单，适合大规模生产。本发明产品可直接喷、涂于烧伤、创伤、糖尿病烂足、褥疮及其它皮肤慢性溃疡等患者的伤口，使用方便，疗效好。
Description
技术领域
本发明涉及生物医药领域，尤其涉及一种层粘连蛋白创面保护膜。
背景技术
众所周知，人体一旦遭受创伤，伤口如果护理不周就会造成伤口感染，严重者可能化脓，经久不愈，甚至引发全身感染、气性坏疽、破伤风等危及生命。伤口感染是病原微生物通过伤口侵入机体后，在体内生长、繁殖，致机体的正常功能、代谢、组织结构受到破坏，引起组织损伤性病变的病理反应。目前用的最多的抗感染类药物就是抗生素类。但抗生素类药物会引起过敏反应；耐药性；白细胞、红细胞、血小板减少；神经系统损害；且长期或大剂量使用广谱抗生素，由于体内敏感细菌被抑制，而未被抑制的细菌以及真菌即趁机大量繁殖，引起菌群失调而致病，因此，应严格掌握抗生素的适应症，避免不合理滥用抗生素。伤口的治疗原则应是尽快缩小创面、防止再损伤和促进组织再生，避免一些不利因素，创造有利条件促进组织再生修复。
层粘连蛋白(laminin，LN)是一种大型的糖蛋白，与IV型胶原一起构成基膜，是胚胎发育中出现最早的细胞外基质成分。所谓基膜是指上皮细胞下方一层柔软的特化的细胞外基质，也存在于肌肉、脂肪和许旺细胞周围，它不仅仅起保护和过滤作用，还决定细胞的极性，影响细胞的代谢、存活、迁移、增殖和分化。在机体生命活动中，LN作为基膜的主要结构成分对基膜的组装起关键作用，在细胞表面形成网络结构并将细胞固定在基膜上；并与多种基底膜成分结合，调节细胞生长和分化，也参与机体众多病理过程。它可能通过巨噬细胞、淋巴细胞等细胞成分释放生长因子，促进成纤维细胞增殖及合成胶原纤维，加重纤维化病变程度， LN参与纤维化的全过程；在细胞发育过程中刺激细胞粘着、细胞运动；LN还能够刺激胚胎中神经轴的生长，并促进成年动物的神经损伤后重生长和再生；大量的研究和临床应用已证明，LN在伤口的修复和愈合中起着十分重要的作用，对难愈合伤口的愈合治疗中具有显著的效果，是促进难愈合创面的关键物质。
微胶囊技术利用天然的或合成的高分子材料，通过化学法、物理法或物理化学法将固体、液体甚至是气体等核心物质包囊成直径为1-5000μm的一种具有半透性或密封囊膜的微小囊状物的技术。通常把构成微胶囊的外壳材料称为“囊材”，把包在微胶囊内部的物质称为“芯材”。药物微胶囊化后可将活细胞或生物活性物质包裹，囊膜有隔离外界与药物接触作用，可防止药物氧化、水解和挥发，提高药物的稳定性；可控制调节释放能力，由于微胶囊膜为半透性膜，故可以改变条件，对芯材的释放时间和速率加以控制，使微胶囊的核心物质以一定的速率逐渐向外释放，延长药物作用时间等。
医药级聚乙烯醇是一种极安全的高分子有机物，对人体无毒，无副作用，具有良好的生物相容性，尤其在医疗中如其水性凝胶在眼科、伤口敷料和人工关节方面的有广泛应用，同时聚乙烯醇薄膜在药用膜，人工肾膜等方面也有使用。其安全性可以从用于伤口皮肤修复，和眼部滴眼液产品可见一斑。其中一些型号也常被用在化妆品中的面膜、洁面膏、化妆水及乳液中，是一种常用的安全性成膜剂。卡波姆是以季戊四醇等与丙烯酸交联得到的丙烯酸交联树脂，是一类非常重要的流变调节剂，中性环境下卡波姆体系是极好的凝胶基质，表观晶莹，手感润滑，非常适合用来制备霜或凝胶剂，同时由于工艺简单，稳定性好，用后感觉舒适，因此在局部给药中，特别是在皮肤及眼用凝胶剂中具有广泛应用。海藻酸钠、海藻酸钙海藻酸钙是从海藻植物中提炼的多糖物质。当它用于伤口接触层时，它与伤口之间相互作用，会产生海藻酸钠、海藻酸钙凝胶。这种凝胶是亲水性的，可使氧气通过而细菌不能通过，并促进新组织的生长。聚乙烯醇、卡波姆、海藻酸钠、海藻酸钙会在创口表面形成凝胶层，对创面起到一定的保护作用，并使创面保持一定的湿度，温度，为创面的愈合创造一个良好的微环境，促使创口及早愈合。
发明内容
本发明的目的在于提供一种可保湿抑菌、疗效稳定、无副作用、用药方便、利于生产、便于保存和运输的层粘连蛋白制剂，该制剂可在创面及伤口形成一层生物蛋白保护膜，这种生物膜可使氧气通过而细菌不能通过，使创面保持一定的湿度，温度，并促进新组织的生长，能够增强细胞或组织修复、再生或维持，可加速患者烧伤、创伤、溃疡等伤口的愈合。
基于上述目的，本发明采取如下技术方案：
本发明的层粘连蛋白创面保护膜是以动物血浆层粘连蛋白为主要成分，加有无菌生理盐水以及药用辅料组成。其具体成分重量份配比为：动物血浆层粘连蛋白微囊1-30份，成膜基质0.1-30份，保湿剂1-10份，无菌生理盐水补足至100份。
其中所述层粘连蛋白微囊是以层粘连蛋白溶液为囊心物，由囊材包裹的微囊；其囊材的浓度为1-8％，芯材与囊材的比例为1∶1～6。
所述囊材为甲基纤维素、乙基纤维素、羧甲基纤维素等纤维素的衍生物、卵磷脂、胆固醇、十八胺、海藻酸盐、聚赖氨酸、脱乙酰几丁酯、蔗糖脂肪酸酯、甘油酯、磷脂酰胆碱等中的一种或两种。
所述一种纤连蛋白微囊制剂的制备方法，其特征在于包括以下步骤：
(1)用无水乙醇作溶剂配制成囊材浓度为1-8％的囊材溶液；
(2)将层粘连蛋白与囊材按1∶1～6的比例加入上述囊材溶液中，在常温、压力40MPa 条件下，均质两次，得到均匀的混悬液；
(3)将上述制备得到的混悬液先放于-20℃冰箱中冷冻，冷冻6h～12h，再转移至真空冷冻干燥机中进行干燥10h～16h，得到的干燥粉末即为层粘连蛋白微胶囊。
所述的成膜基质为聚乙烯醇、卡波姆、海藻酸钠、海藻酸钙中的一种或几种。
所述的保湿剂为医用甘油或椰子油、棉籽油、花生油、芝麻油等植物油中的一种。
LN作为基膜的主要结构成分对基膜的组装起关键作用，在细胞表面形成网络结构并将细胞固定在基膜上，在伤口处刺激细胞粘着、细胞运动、上皮细胞的迁移和增殖以修复伤口，加速伤口愈合，减轻愈合疤痕。由于LN分子在进化的过程中保守性很强，各种动物液体中的LN具有非常相似的结构、性质和生物学功能，不同来源的LN可以相互替代使用。本发明采用低温冷冻干燥法将层粘连蛋白制成微囊，囊膜有隔离外界与药物接触作用，可以有效地保持物料原有的天然色泽、风味以及形态，改变其易受外界环境影响而失去活性、提高药物的稳定性；可控制调节释放能力，由于微胶囊膜为半透性膜，故可以改变条件，对芯材的释放时间和速率加以控制，使微胶囊的核心物质以一定的速率逐渐向外释放，延长药物作用时间等。聚乙烯醇、卡波姆、海藻酸钠、海藻酸钙会在创口表面形成凝胶层，这种凝胶是亲水性的，可使氧气通过而细菌不能通过，并促进新组织的生长。甘油或植物油具有润肤并对 LN的生物活性有一定的保护作用。
本发明层粘连蛋白创面保护膜是以动物血浆LN为主要原料，添加成膜基质和保湿剂，可在创口表面形成一层生物蛋白保护膜，对创面起到一定的保护作用，避免伤口感染，并使创面保持一定的湿度，温度，为创面的愈合创造一个良好的微环境，促使创口及早愈合。
本发明可制成水剂或凝胶剂型。本发明产品可直接喷、涂于烧伤、创伤、溃疡等患者的伤口。
本发明产品具有以下优势：
(1)LN可能通过巨噬细胞、淋巴细胞等细胞成分释放生长因子，促进成纤维细胞增殖及合成胶原纤维，为伤口的修复提供良好的细胞外环境，在伤口处刺激细胞粘着、细胞运动、上皮细胞的迁移和增殖以修复伤口，增强细胞或组织修复、再生或维持，可加速患者烧伤、创伤、溃疡等伤口的愈合，减轻愈合疤痕。
(2)本产品可在创口表面形成一层生物蛋白保护膜，可使氧气通过而细菌不能通过，对创面起到一定的保护作用，避免伤口感染，并使创面保持一定的湿度，温度，为创面的愈合创造一个良好的微环境，促使创口及早愈合。
(3)本发明采用低温冷冻干燥法将层粘连蛋白制成微囊，可以有效地保持物料原有的天然色泽、风味以及形态，改变其易受外界环境影响而失去活性、不方便运输和保存的缺点，有利于运输、保藏和使用。
(4)本发明将层粘连蛋白制成微囊，由于微胶囊膜为半透性膜，故可以改变条件，对芯材的释放时间和速率加以控制，使微胶囊的核心物质以一定的速率逐渐向外释放，可控制调节释放能力，延长药物作用时间。
(5)本层粘连蛋白创面保护膜中所用辅料成膜基质和保湿剂可保持伤口湿润，防止干裂，同时可保持LN的生物活性，最大限度的发挥LN创面修复细胞作用，提高LN的生物利用度，功效好，无副作用，属于纯天然生物制品。
(6)本产品中制剂材料来源广泛，成本低廉，制备工艺简单，具有非常好的应用前景。
具体实施方式
下面结合具体实施例，对本发明作进一步的说明。
实施例1 凝胶剂
1、动物血浆层粘连蛋白微囊其囊材的浓度为8％，芯材与囊材的比例为1∶6；具体制备方法包括以下步骤：
(1)用无水乙醇作溶剂配制成浓度为8％的羧甲基纤维素囊材溶液；
(2)将层粘连蛋白与囊材按1∶6的比例加入上述囊材溶液中，在常温、压力40MPa条件下，均质两次，得到均匀的混悬液；
(3)将上述制备得到的混悬液先放于-20℃冰箱中冷冻，冷冻12h，再转移至真空冷冻干燥机中进行干燥16h，得到的干燥粉末即为层粘连蛋白微囊。
2、取上述步骤1中制备的动物血浆层粘连蛋白微囊30份，卡波姆0.3份，海藻酸钠15 份，医用甘油5份，无菌生理盐水补足至100份。搅拌使乳化均匀，制成凝胶剂。
3、按规格要求罐封于无菌塑料瓶内，即为层粘连蛋白创面保护膜产品。
实施例2：水剂
1、动物血浆层粘连蛋白微囊其囊材的浓度为3％，芯材与囊材的比例为1∶2；具体制备方法包括以下步骤：
(1)用无水乙醇作溶剂配制成浓度为3％的甘油酯囊材溶液；
(2)将层粘连蛋白与囊材按1∶2的比例加入上述囊材溶液中，在常温、压力40MPa条件下，均质两次，得到均匀的混悬液；
(3)将上述制备得到的混悬液先放于-20℃冰箱中冷冻，冷冻10h，再转移至真空冷冻干燥机中进行干燥12h，得到的干燥粉末即为层粘连蛋白微囊。
2、取上述步骤1中制备的动物血浆层粘连蛋白微囊3份，聚乙烯醇2份、海藻酸钠1份和医用甘油3份加入91份无菌生理盐水中充分混合，得到均匀的混合溶液；
3、将步骤2得到的混合溶液经0.22μm滤膜除菌，按规格要求罐封于无菌塑料瓶内，即为层粘连蛋白创面保护膜产品。按药典无菌检测方法要求检测，产品应无菌。
4、应用时直接喷涂到处理干净的伤口处。
本发明的产品经临床应用试验，获得良好效果。经专业检验机构检测，其理化指标和毒性试验，均符合卫生要求。
Claims (6)
1.一种层粘连蛋白创面保护膜，其特征在于：它是以动物血浆层粘连蛋白为主要成分，加有无菌生理盐水以及药用辅料组成，其具体成分重量份配比为：动物血浆层粘连蛋白微囊1-30份，成膜基质0.1-30份，保湿剂1-10份，无菌生理盐水补足至100份。
2.根据权利要求1所述的一种层粘连蛋白创面保护膜，其特征在于：所述层粘连蛋白微囊是以层粘连蛋白溶液为囊心物，由囊材包裹的微囊；其囊材的浓度为1-8％，芯材与囊材的比例为1∶1～6。
3.根据权利要求1所述的层粘连蛋白创面保护膜，其特征在于：所述囊材为甲基纤维素、乙基纤维素、羧甲基纤维素等纤维素的衍生物、卵磷脂、胆固醇、十八胺、海藻酸盐、聚赖氨酸、脱乙酰几丁酯、蔗糖脂肪酸酯、甘油酯、磷脂酰胆碱等中的一种或两种。
4.根据权利要求2所述的一种层粘连蛋白创面保护膜，其特征在于：所述一种层粘连蛋白微囊制剂的制备方法，其特征在于包括以下步骤：
(1)用无水乙醇作溶剂配制成囊材浓度为1-8％的囊材溶液；
(2)将层粘连蛋白与囊材按1∶1～6的比例加入上述囊材溶液中，在常温、压力40MPa条件下，均质两次，得到均匀的混悬液；
(3)将上述制备得到的混悬液先放于-20℃冰箱中冷冻，冷冻6h～12h，再转移至真空冷冻干燥机中进行干燥10h～16h，得到的干燥粉末即为层粘连蛋白微胶囊。
5.根据权利要求1所述的一种层粘连蛋白创面保护膜，其特征在于：所述成膜基质为聚乙烯醇、卡波姆、海藻酸钠、海藻酸钙中的一种或几种。
6.根据权利要求1所述的层粘连蛋白创面保护膜，其特征在于：所述的保湿剂为医用甘油或椰子油、棉籽油、花生油、芝麻油等植物油中的一种。
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| WO2008040230A1 (fr) * | 2006-09-15 | 2008-04-10 | Zhengzhou Tongyuan Biotechnology Co., Ltd. | Consolidant à base de fibronectine agissant sur les traumatismes et les ulcères |
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