CN1325125C - 一种防粘连生物膜 - Google Patents
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Abstract
本发明涉及医用生物材料技术领域，是一种预防创伤及术后粘连的生物膜。本发明生物膜组分包含羧甲基纤维索、羧甲基壳聚糖、硫酸铝铵、戊二醛、甘油和水。本发明生物膜拉伸强度大，有利于术后缝合；在体内维持时间长，能有效防止术后创面粘连。
Description
技术领域
本发明涉及医用生物材料技术领域，是一种预防创伤及术后粘连的生物膜。
背景技术
在施行腹腔、心血管、脊柱、关节及肌腱等部位的外科手术后，普遍存在手术性粘连问题。术后粘连不仅会影响手术效果，还可导致严重的术后并发症，甚至会使一个成功手术归于失败。因此防止术后粘连一直是研究者努力解决的问题。许多研究者用了不同的材料试图用物理或化学的方法来阻止瘢痕产生及与组织的粘连，所得结果各不相同，但均有这样或那样的缺陷，如抗粘连效果不佳、不能完全解决免疫性、生物降解性问题、机械强度不够等。近年来国内外研究较多的抗粘连、可降解的生物材料是透明质酸钠、壳聚糖、羧甲基纤维素，它们在临床中的抗粘连效果也得到证实。但大多应用的只是它们的溶液及凝胶，其缺点在于放入体内后可随体位及引流而使创面部位浓度下降，削弱了抗粘连的效果。目前国外研制的防术后粘连并已在市场上应用的薄膜中效果较好是Seprafilm，其主要成分为透明质酸HA和羧甲基纤维素CMC，该生物膜具有良好的生物相容性，能生物降解而不影响吻合口愈合(见：Beck DE.The role of Seprafilmbioresorbable membrane in adhesion prevention.Eur J Surg Suppl，1997；(577)：49-55.)。但是Seprafilm也有非常明显的缺陷：其一是膜的强度不够，难以满足术中缝合之需要，尤其在湿态下可操作性较差；其二是膜在体内维持时间较短，24-48小时就水化成凝胶，一周左右就被降解吸收。对于需要抗粘连持续时间较长的部位就难以满足临床需要。
发明内容
本发明提供一种拉伸强度大、在体内维持时间长的防粘连生物膜。其组分包含羧甲基纤维素、羧甲基壳聚糖、交联剂、增塑剂、保湿剂和水。主要成分为羧甲基纤维素和羧甲基壳聚糖，有实验已证实壳聚糖比透明质酸钠有更强的抑制成纤维细胞增殖的作用，因此具有更强的抗粘连作用(见：汤朝辉，侯春林，张玲珍。几丁聚糖和透明质酸钠对成纤维细胞增殖影响的实验研究。中国矫形外科杂志，2002，10(1)：1092-1093)。羧甲基壳聚糖除具有壳聚糖的特性外，因其为水溶性，故比壳聚糖具有更好的生物相容性(见：郑立，陈西广，刘万顺，等。羧甲基壳聚糖膜对皮肤成纤维细胞相容性研究。生物化学与生物物理进展，2003，30(2)：314-320)。更重要的是羧甲基壳聚糖抗术后粘连效果优于透明质酸钠，其与羧甲基纤维素形成膜后不仅使抗粘连效果叠加增强；而且抗张强度明显增大，尤其是在湿态下，膜的拉伸强度最大可达4.5Mpa，这有利于术中的缝合；还延长了膜的水化时间，使膜在体内可维持10-14天，从而可充分发挥抗粘连作用。经动物实验证实本发明的生物膜抗粘连效果良好。
本发明生物膜以水为溶剂各成分的浓度如下(即混合溶液中所占的质量百分比w/v)：
羧甲基纤维素0.5-1％ 羧甲基壳聚糖0.5-1％ 硫酸铝铵0.1-0.2％ 甘油0.5％-1.0％ 戊二醛0.002-0.004％
其中，硫酸铝铵为羧甲基纤维素的交联剂，戊二醛为羧甲基壳聚糖的交联剂，甘油为增塑剂和保湿剂。
制备方法有两种：
一.按比例先将硫酸铝铵固体溶于蒸馏水配成硫酸铝铵溶液。再将羧甲基纤维素粉末和羧甲基壳聚糖粉末分别加入硫酸铝铵溶液，快速搅拌溶解。然后加入甘油、戊二醛充分搅拌。最后将溶液放入真空干燥箱中脱泡、流延、烘箱中干燥成膜。
二.按比例先将羧甲基纤维素粉末和羧甲基壳聚糖粉末加入蒸馏水中配成溶液(或分别配制后再混合)，再分别加入甘油、戊二醛、硫酸铝铵充分搅拌。然后将溶液放入真空干燥箱中脱泡、流延、烘箱中干燥成膜。
在本发明的生物膜制备过程中，羧甲基纤维素的交联剂采用含Al3+的化学试剂如氯化铝、硫酸铝铵等均可，优选为硫酸铝铵，因无毒、人体可吸收，目前多用作食品添加剂。羧甲基壳聚糖的交联剂可选自环氧氯丙烷、苯二异氰酸酯、甲醛、戊二醛、乙二醇双缩水甘油醚等，优选为戊二醛。羧甲基纤维素和羧甲基壳聚糖在膜中的组成比可按需选择，但经试验反复证实，羧甲基纤维素和羧甲基壳聚糖按质量比1∶1时各项性能最佳，采用第一种制备方法成膜效果最好。
具体实施方式
现结合实施例，对本发明作详细描述：
实施例1：将0.015g硫酸铝铵固体放入10ml蒸馏水中，在60℃下使其溶解，配成硫酸铝铵溶液。再将0.1g羧甲基纤维素粉末溶于硫酸铝铵溶液中，快速搅拌至溶解后再加入0.1克羧甲基壳聚糖粉末继续搅拌至完全溶解。再依次加入10％甘油0.8ml、0.25％戊二醛0.14ml充分搅拌。然后将溶液放入真空干燥箱中脱泡，真空压力为0.1mpa。最后将溶液加入5cm×5cm的不锈钢盒中流延，置70℃烘箱中干燥成膜。
实施例2.：分别将0.1g羧甲基纤维素和0.1g羧甲基壳聚糖两种粉末依次加入10ml的蒸馏水至完全溶解。再依次加入10％的甘油0.8ml、0.25％戊二醛0.14ml、硫酸铝铵固体0.015g充分搅拌。然后将溶液放入真空干燥箱中脱泡，真空压力为0.1mpa。最后将溶液加入5cm×5cm的不锈钢盒中流延，置70℃烘箱中干燥成膜。
生物膜拉伸强度采用CMT6202拉力机(长春第一机械制造厂)
在室温下进行测试。将生物膜剪成长40mm，宽20mm，以20mm/分钟的速度缓慢拉伸，测试膜在干态下的拉伸强度。然后再将同样大小的膜放入蒸馏水中浸泡1小时，测试膜在湿态下的拉伸强度。经测试，实施例1干膜拉伸强度为15.0Mpa，湿态下为4.5Mpa；实施例2干膜拉伸强度为8.6Mpa，湿态下为2.4Mpa。
动物实验：采用20只SD大鼠，分10组，每组2只，观察降解情况。再用20只分成对照组与实验组，每组10只，观察抗粘连情况。以3％戊巴比妥钠2mL/Kg腹腔内注射麻醉大鼠，麻醉成功后仰卧位固定大鼠，剪去腹正中约5cm×3cm的毛发，常规消毒腹部皮肤，取腹正中长约3cm的切口逐层进腹，探查腹腔无明显炎性病变后，找到并提出蚓突(相当于人的阑尾)，从系膜无血管区游离蚓突盲端约3cm，以手术刀片轻刮盲端前侧面至浆膜层充血伴渗血，将按上述方法制备的生物膜包绕蚓突一圈(盲端3cm范围内)后用可吸收缝合线缝合膜两端，再将蚓突送回腹腔，关腹。分别于术后第1，2，4，8，10，12，14，20，24，30天解剖，肉眼观察膜的体内降解变化、对大鼠肠粘连预防情况，取局部蚓突组织及膜周围组织进行病理组织学检查。结果表明该生物膜在术中能够满足手术缝合之需要，在体内约10-14天膜水化成凝胶状态，一月后完全吸收降解。与对照组相比明显减轻了蚓突与腹腔的粘连程度、粘连范围，病理组织学检查显示膜周围组织炎性反应较轻，膜的生物相容性较好。
本发明生物膜拉伸强度大，有利于手术缝合；在体内维持时间长，能有效防止术后创面粘连。
Claims (2)
1.一种防粘连生物膜，其组分包含羧甲基纤维素、羧甲基壳聚糖、交联剂、增塑剂、保湿剂和水，其特征在于交联剂为硫酸铝铵和戊二醛，羧甲基纤维素的交联剂为硫酸铝铵，羧甲基壳聚糖的交联剂为戊二醛，保湿剂和增塑剂为甘油，以水为溶剂各组分的质量百分比浓度为：
羧甲基纤维素0.5-1％ 羧甲基壳聚糖0.5-1％
硫酸铝铵0.1-0.2％ 甘油0.5-1％
戊二醛0.002-0.004％，
制备方法如下：按所说配比先将硫酸铝铵溶于蒸馏水配成硫酸铝铵溶液，再将羧甲基纤维素粉末和羧甲基壳聚糖粉末分别加入硫酸铝铵溶液，快速搅拌溶解，然后加入甘油、戊二醛充分搅拌，最后将溶液在真空干燥箱中脱泡、流延、干燥成膜。
2.按权利要求1所述的防粘连生物膜，其特征在于各组分配比如下：
羧甲基纤维素0.1g 羧甲基壳聚糖0.1g
硫酸铝铵0.015g 10％甘油0.8ml
0.25％戊二醛0.14ml 蒸馏水10ml。
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Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101099874B (zh) * | 2006-07-04 | 2010-08-25 | 孙雨龙 | 生物偶连材料及其制备方法 |
| WO2009078492A1 (ja) * | 2007-12-17 | 2009-06-25 | Teijin Limited | セルロース誘導体およびそのハイドロゲル |
| CN102397587A (zh) * | 2010-09-08 | 2012-04-04 | 舒朝锋 | 一种宫腔防粘连材料及其制备工艺和用途 |
| CN102653600B (zh) * | 2011-03-04 | 2015-04-22 | 温州医学院 | 一种可食性包装膜及其制备方法 |
| CN109206641A (zh) * | 2017-07-07 | 2019-01-15 | 孙雨龙 | 一种可生物降解膜及其制备方法和应用 |
| CN108586133A (zh) * | 2018-05-21 | 2018-09-28 | 施秀英 | 玉米专用有机肥的制备方法 |
| CN108409453A (zh) * | 2018-05-21 | 2018-08-17 | 施秀英 | 番茄专用有机肥的制备方法 |
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| US5017229A (en) * | 1990-06-25 | 1991-05-21 | Genzyme Corporation | Water insoluble derivatives of hyaluronic acid |
| US5527893A (en) * | 1987-09-18 | 1996-06-18 | Genzyme Corporation | Water insoluble derivatives of polyanionic polysaccharides |
| US5760200A (en) * | 1987-09-18 | 1998-06-02 | Genzyme Corporation | Water insoluble derivatives of polyanionic polysaccharides |
| US6150581A (en) * | 1995-06-07 | 2000-11-21 | United States Surgical Corporation | Chitosan/alginate anti-adhesion barrier |
| US6472379B1 (en) * | 1999-03-15 | 2002-10-29 | Trustees Of Boston University | Angiogenesis inhibition |
| CN1429559A (zh) * | 2001-12-26 | 2003-07-16 | 阿米带有限公司 | 一种抗粘连隔离物 |
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| US5527893A (en) * | 1987-09-18 | 1996-06-18 | Genzyme Corporation | Water insoluble derivatives of polyanionic polysaccharides |
| US5760200A (en) * | 1987-09-18 | 1998-06-02 | Genzyme Corporation | Water insoluble derivatives of polyanionic polysaccharides |
| US5017229A (en) * | 1990-06-25 | 1991-05-21 | Genzyme Corporation | Water insoluble derivatives of hyaluronic acid |
| US6150581A (en) * | 1995-06-07 | 2000-11-21 | United States Surgical Corporation | Chitosan/alginate anti-adhesion barrier |
| US6472379B1 (en) * | 1999-03-15 | 2002-10-29 | Trustees Of Boston University | Angiogenesis inhibition |
| CN1429559A (zh) * | 2001-12-26 | 2003-07-16 | 阿米带有限公司 | 一种抗粘连隔离物 |
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