CN103948929A - 骨科手术用防粘连粉雾剂及其制备方法 - Google Patents
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Abstract
本发明属于医药领域,具体涉及一种骨科手术用防粘连粉雾剂及其制备方法,由透明质酸钠、甲壳素衍生物和大分子隔离物组成,其中,透明质酸钠、甲壳素衍生物和大分子隔离物三者的质量比为1∶0.3~1∶0.1~0.5。制备时将透明质酸钠、甲壳素衍生物和大分子隔离物按上述配方称取混合,然后研磨成细粉,将细粉过200目筛,过筛后细粉用铝箔袋包装,经环氧乙烷或微波除菌后,即得骨科手术用防粘连粉雾剂。本发明的优点在于:药物的各成分之间相互配合,并制成粉雾剂使用,在预防术后关节组织间粘连、创面修复愈合和镇痛方面具有显著的作用,且质量稳定,成本低,使用方便,与组织的粘附性好,符合临床使用要求。
Description
技术领域
本发明属于医药领域,具体涉及一种骨科手术用防粘连粉雾剂及其制备方法。
背景技术
关节粘连是指关节周围的皮肤、肌肉、肌腱,血管神经等发生变化而引起的运动障碍。人体的组织中有疏松成分和致密成分,前者构成关节囊、肌肉结合组织层、皮下组织等,都是经常活动的部分,组织学上胶原纤维和细网纤维没有网状,不具备一定的构造。与此相反,致密的结合组织,像肌膜、腱膜等的构成致密网状结构。伤后形成的瘢痕就是这种组织。骨科关节创伤的治疗过程中,若保持该处的运动,则疏松的结合组织得以保持存在,相反若治疗过程中运动受限,则致密结合组织增殖,受损处的运动性显著受限,这是外伤后粘连的发生机制。除此之外的粘连即最常见的关节不活动所致的粘连机制也与此相同,由于缺乏运动,血液循环减慢疏松组织短缩,失去弹性、滑动及伸展性而形成致密组织。这样的过程发生在关节囊、肌膜、肌肉结合组织、韧带等,而导致关节活动受限。即使是正常的关节固定4周的话,也会产生相当程度的粘连。
骨科手术中发生关节粘连常见有以下三种原因:(1)创伤后关节粘连,如膝关节韧带,半月板损伤等;(2)内固定术后,石膏固定后,小夹板固定术后。(3)废用性关节粘连,如长期卧床所致腰椎关节粘连,髋关节粘连,膝关节粘连。
发明内容
根据以上现有技术的不足,本发明提供一种骨科手术用防粘连粉雾剂及其制备方法,用于预防关节内窥镜检查、神经组织周围、肌腱修复等骨科手术后组织粘连,具有体内存留时间长,防粘连效果显著的作用。
本发明所述的一种骨科手术用防粘连粉雾剂,由透明质酸钠、甲壳素衍生物和大分子隔离物组成,其中,透明质酸钠、甲壳素衍生物和大分子隔离物三者的质量比为1:0.3~1:0.1~0.5。
其中,所述的甲壳素衍生物优选为羧甲基甲壳素、羟丙基甲壳素或琥珀酰甲壳素中的一种。
大分子隔离物优选为羧甲基纤维素、羟丙基纤维素、右旋糖酐、硫酸软骨素或海藻酸钠中的一种。
一种骨科手术用防粘连粉雾剂的制备方法,将透明质酸钠、甲壳素衍生物和大分子隔离物按上述配方称取混合,然后研磨成细粉,将细粉过200目筛,过筛后细粉用铝箔袋包装,经环氧乙烷或微波除菌后,即得骨科手术用防粘连粉雾剂。
透明质酸钠是一种线性聚阴离子多糖,作为人体生理所必需的物质,它广泛存在于动物的各种组织中,包括结缔组织、皮肤、软骨、眼玻璃体和滑液等。透明质酸钠分子量可达四百万至五百万道尔顿,在水溶液中,以无规则螺旋形式存在,有很大的分子容积,在低浓度下能够交织缠绕并互相透入,使其具有特定的流变学特性。透明质酸钠防止术后关节组织粘连的机理可归纳为:(1)溶解后形成多分子网络结构,将受伤的组织与正常浆膜分离,起到空间阻隔作用和润滑作用,减少摩擦;(2)抑制出血和渗出,减少能形成永久粘连骨架的血块数量,抑制蛋白沉着;(3)抑制术后炎症细胞迁移和吞噬作用,抑制血小板的沉积,促进伤口愈合;(4)刺激浆膜细胞的生长和分化,使创伤浆膜达到生理性修复。此外,透明质酸钠粉雾剂在防止术后粘连方面优于透明质酸钠溶液和凝胶,透明质酸钠溶液和凝胶由于浓度低,分子量小,在体内很快就被吸收降解,削弱了它在组织表面的阻隔作用,而透明质酸钠粉雾剂喷洒于组织表面后,有一逐步溶解过程,同时在局部形成高浓度凝胶,局部粘弹性高且体内存留时间长,在浆膜修复期形成有效的屏障,所以它的防粘连效果显著。
甲壳素衍生物是一种壳聚糖,本发明选用羧甲基甲壳素、羟丙基甲壳素或琥珀酰甲壳素中的一种。甲壳素衍生物对人体细胞具有良好的亲和性,抗原性低,安全性高,在人体受伤部位能活化细胞,大量产生胶原纤维,胶原纤维可迅速形成细致的皮肤,不会留下疤痕,在治疗烧伤、烫伤、外伤、加速伤口愈合、止血、消炎方面疗效独特。甲壳素衍生物制成的粉雾剂在预防术后组织粘连、创面修复愈合和镇痛方面具有显著的作用。
本发明将透明质酸钠与甲壳素衍生物相结合,再配以大分子隔离物,发明人经过大量实验研究,确定三者配比关系,从而达到防止粘连效果的最大化。
本发明的优点在于:药物的各成分之间相互配合,并制成粉雾剂使用,在预防术后关节组织间粘连、创面修复愈合和镇痛方面具有显著的作用,且质量稳定,成本低,使用方便,与组织的粘附性好,符合临床使用要求。
具体实施方式
以下结合实施例对本发明做进一步说明。
实施例1:
一种骨科手术用防粘连粉雾剂,由透明质酸钠、羧甲基甲壳素和羧甲基纤维素组成,三者的质量比为1:1:0.5。
实施例2:
一种骨科手术用防粘连粉雾剂,由透明质酸钠、羟丙基甲壳素和右旋糖酐组成,三者的质量比为1:0.5:0.3。
实施例3:
一种骨科手术用防粘连粉雾剂,由透明质酸钠、琥珀酰甲壳素和海藻酸钠组成,三者的质量比为1:0.3:0.2。
实施例1~3按照下述制备方法制备,将透明质酸钠、甲壳素衍生物和大分子隔离物按上述配方称取混合,然后研磨成细粉,将细粉过200目筛,过筛后细粉用铝箔袋包装,经环氧乙烷或微波除菌后,即得骨科手术用防粘连粉雾剂。
Claims (4)
1.一种骨科手术用防粘连粉雾剂,其特征在于由透明质酸钠、甲壳素衍生物和大分子隔离物组成,其中,透明质酸钠、甲壳素衍生物和大分子隔离物三者的质量比为1:0.3~1:0.1~0.5。
2.根据权利要求1所述的骨科手术用防粘连粉雾剂,其特征在于甲壳素衍生物为羧甲基甲壳素、羟丙基甲壳素或琥珀酰甲壳素中的一种。
3.根据权利要求1所述的骨科手术用防粘连粉雾剂,其特征在于大分子隔离物为羧甲基纤维素、羟丙基纤维素、右旋糖酐、硫酸软骨素或海藻酸钠中的一种。
4.一种权利要求1所述的骨科手术用防粘连粉雾剂的制备方法,其特征在于将透明质酸钠、甲壳素衍生物和大分子隔离物按上述配方称取混合,然后研磨成细粉,将细粉过200目筛,过筛后细粉用铝箔袋包装,经环氧乙烷或微波除菌后,即得骨科手术用防粘连粉雾剂。
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| WO2001082863A2 (en) * | 2000-04-28 | 2001-11-08 | Fziomed, Inc. | Polyacid/polyalkylene oxide foams and gels and methods for their delivery |
| CN1899265A (zh) * | 2006-07-08 | 2007-01-24 | 青岛博益特生物材料有限公司 | 一种医用粉雾剂或颗粒剂及其应用 |
| CN101537205A (zh) * | 2009-04-10 | 2009-09-23 | 暨南大学 | 一种可降解型医用止血防粘连材料及其制备方法 |
| US20120064145A1 (en) * | 2010-09-09 | 2012-03-15 | China Medical University | Wound dressing |
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Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2001082863A2 (en) * | 2000-04-28 | 2001-11-08 | Fziomed, Inc. | Polyacid/polyalkylene oxide foams and gels and methods for their delivery |
| CN1899265A (zh) * | 2006-07-08 | 2007-01-24 | 青岛博益特生物材料有限公司 | 一种医用粉雾剂或颗粒剂及其应用 |
| CN101537205A (zh) * | 2009-04-10 | 2009-09-23 | 暨南大学 | 一种可降解型医用止血防粘连材料及其制备方法 |
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